Roche Products and Diagno.

Products and Solutions 2016
Roche Diagnostics
Diagnostics – the building block of healthcare
Healthcare is undergoing a paradigm Roche, as global leader in diagnostics,

shift. As people live longer, grow older and is pioneering this shift in the healthcare
face serious illness – such as cancer, landscape. Through our unrivalled
heart disease and diabetes – there are investment in research and development;
new challenges for both patients and our novel and medically differentiated
care-givers. The strain on healthcare assays; our integrated systems; connected
systems and resources is undeniable workflows and technologies, we are trans-
but not insuperable. forming laboratory practice now and forever.
As we continue to innovate across the
A more intelligent and effective approach patient care pathway, we are pursuing our
to healthcare is now in our grasp – vision of making data available anytime
one in which in vitro diagnostics plays an and anywhere and delivering real value to
integral role. healthcare systems.
Through providing the right information, The result is better, healthier lives for
diagnostics enable healthcare professionals patients, and healthcare systems poised for
to work more knowledgeably so that the long term.
they can make better treatment decisions.
Driving this change are the new biomarkers That is the power – the power of knowing.
and testing technologies, which give
laboratories an expanded role in delivering
improved patient outcomes.
The value of in vitro diagnostics Roche is the leader in
Laboratories play a pivotal role in clinical Personalized Healthcare
decision-making
IVD accounts for ~ 2 % of worldwide IVD influences > 60 % of clinical Diagnostics Pharmaceuticals
healthcare spending decision-making
At Roche we combine technical competence with therapeutic insights.
Increased value of Diagnostics patients can now benefit from targeted With our leading Pharmaceuticals and identify patient subsets for clinical trials,
In vitro diagnostics (IVDs) have long been treatments based on the presence of Diagnostics businesses under one roof, we and once the targeted medicine is in the
considered as the “silent champion” of specific genetic defects or biomarkers in are better positioned to deliver Personalized marketplace, the approved IVD test is used
healthcare, influencing over 60 % of clinical their blood or tissue. Targeted therapies Healthcare than any other company. An for treatment selection, response prediction
decision-making, while accounting for only and diagnostic tests that help to improve exchange of know-how and intellectual and therapeutic monitoring. Personalized
about 2 % of total healthcare spending. medical decision-making not only offer property, combined with our breadth of Healthcare is our core strategy and around
clinical benefits for patients but are also diagnostic technologies, allows for fast 60 % of our solutions in the pipeline involve
The role of IVDs is set to grow with today’s attractive through health economic assay development and technical validation. this approach.
changes in healthcare. With the develop- enefits to regulatory authorities and payers.
b A robust research diagnostic is essential to
ment of Personalized Healthcare (PHC),
2|3
Our business strategy
Differentiation with testing efficiency and
medical value throughout the entire healthcare
value chain
In modern healthcare, in vitro diagnostics decision-making along the entire continuum

go far beyond simply telling a doctor of a patient’s health or disease, enabling • Revalue Diagnostics
whether a patient has a certain disease physicians to make full use of IVDs along • Focus on unmet needs
• Deliver clinical evidence
Importance
or not. Today, they are an integral part of the healthcare value chain.
Medical Value
• Total lab solutions

Screening Diagnosis Prognosis Stratification Monitoring • Modular offerings
Testing Efficiency • Comprehensive menues
• Lab IT and workflow
HPV NT-proBNP Troponin T HER2 Prothrombin
time 2015 2020
Knowing whether Knowing whether Knowing whether Knowing whether Knowing you Roche Diagnostics differentiates itself We prioritize those areas with the highest
a woman is a patient has a patient could it’s HER2 positive are taking the through innovation in testing efficiency unmet medical need and devote substantial
at risk of heart failure, a die within 30 days breast cancer right dosage of and medical value resources to acquiring the necessary inte
developing disease that after surgery anticoagulant
cervical cancer can be misdiag- We develop evidence-based diagnostic tests llectual property to develop new tests and
nosed half the that address unmet medical needs. Our then demonstrate their clinical utility and
time based on tests and highly efficient laboratory solutions health economic benefit.
symptoms alone
help improve people’s health and quality
of life. Increasing testing efficiency
Healthy Asymptomatic/Symptomatic disease Chronic disease
Roche continues to develop diagnostic
Enhancing medical value solutions with improved speed, accuracy
Improve people and patients’ lives and making healthcare sustainable Increasingly our efforts are concentrated on and reliability through automation,
leveraging advanced scientific knowledge workflow, and IT integration. We enable
and technological progress to increase the laboratories to better manage expanding
Continuum of care with examples of diagnostic tests in different disease areas and the support they give in clinical
decision-making. medical value of our diagnostic offering. testing and data volumes. We further
Medical value is delivered by tests for drive laboratory efficiency by providing
screening, diagnosis, prediction, and moni- our customers with modular solutions
toring of disease, as well as by companion and comprehensive test menus.
diagnostic tests used for treatment selection
or predicting a patient’s response to a
specific drug.
4|5
Roche Diagnostics’ areas of expertise “We are committed to delivering the best possible
diagnostic solutions to improve people’s lives.
Covering all in vitro diagnostic segments Sustainable healthcare depends on diagnostics,
in all major healthcare areas and as the leader in the industry, we have the
opportunity to shape healthcare delivery and to opti-
mize resources in order to ultimately benefit society
as a whole.”
Roche Diagnostics serves customers Roche Diagnostics offers the industry’s Roland Diggelmann, COO Roche Diagnostics
spanning the entire healthcare spectrum – broadest range of diagnostic tests. Our
from research institutions, hospitals and pioneering technologies and solutions not
commercial laboratories to physicians and only help ensure an accurate diagnosis,
patients. Performed on blood, tissue or they can detect the risk of disease, predict
other patient samples, in vitro diagnostics how a disease may progress, and enable
are a critical source of objective information the right treatment decision at the outset.
for improved disease management and
patient care. We help patients gain control over chronic
conditions by enabling both physicians
and patients to monitor treatment progress.
And, through our successful collaboration
with laboratories, we provide the fast and
reliable results needed for life-changing We focus on all major healthcare areas
Research
Research
Research Clinical Clinical
Clinical applications
applications
applications
Research Research
Research Clinical applications
decisions.Clinical
Clinical
applications
applications Oncology Cardiology & metabolism Infectious diseases
Research Clinical applications
Academia Pharma Blood bank Commercial Hospital Physician’s Patient

lab office homes
mia PharmaPharma
Academia
Academia
Academia
Academia Commercial
Pharma
PharmaPharma lab labHospital
Commercial
Commercial
Commercial
Commercial lab
lab HospitalPhysician’s
lab Hospital
Hospital
Hospital office
Physician’s Patient
Physician’s
Physician’s officehomes
Physician’s
office
office office
PatientPatient
homes
Patient
Patient homes homeshomes
Academia
• Life sciences Pharma
• Blood •Commercial lab
Central laboratory Hospital
• Molecular testing •Physician’s
Self-testing office Patient homes
• Sequencing screening • Point of care • Anatomic pathology
• Life sciences
• Life• •Life
Lifesciences
sciences
sciences• Life sciences • Central •laboratory
• Central
Central • Central
laboratory
Central • Molecular
laboratory
laboratorylaboratorytesting
• •Molecular
• Molecular •testing
Molecular
Molecular testing •testing
testing Self monitoring
• Self
• Self monitoring
•monitoring
Self monitoring
monitoring
• Self
• Life sciences • Central laboratory • Molecular testing • Self monitoring
• Sequencing • •Sequencing
Sequencing
• Sequencing • Sequencing • Point of• care•• Point
Point of
of care
Point of care •ofAnatomic
• Point
care pathology
care • Anatomic
• •Anatomic
• Anatomic
Anatomic pathology
pathology pathology
pathology Blood safety Women’s health Critical care
• Sequencing • Point of care • Anatomic pathology
6|7
Roche Diagnostics commitment Contents
Providing innovation and excellence today
and tomorrow
We offer a pioneering partnership Global and local expertise and dedicated Serum Work Area soutions.�� 13 Elecsys® TORCH panel��68
to make the maximum contribution service and support teams in over 130 cobas® modular platform�� 14 Elecsys® Troponin T
to patient care countries are there to support you every cobas® 8000 modular analyzer series��16 high sensitive (TnT hs)�� 70
As a leader in IVD solutions, we are your step of the way. Our commitment and rich cobas 6000 analyzer series��20
®
Elecsys® NT-proBNP��72
dedicated partner supporting you through pipeline of differentiated solutions and cobas 4000 analyzer series��24
®
Lp(a), hsCRP and Homocysteine�� 74
our technologies for centralized and technologies are there all the way to sup- cobas c 111 analyzer��26 Elecsys® IL-6, PCT and Tina-quant® CRP�� 76
decentralized settings, in molecular and port you in providing improved patient care COBAS INTEGRA 400 plus��28
®
Elecsys® tumor marker portfolio�� 78
tissue testing as well as automation – today and also tomorrow. NEW cobas c 513 analyzer��30 Elecsys® HE4��80
and IT solutions. Automation & IT solutions��32 Elecsys® ProGRP��82
cobas middleware solutions��34 NEW Elecsys® SCC��84
In a pioneering partnership we provide cobas infinity IT solutions��36
®
Elecsys® Calcitonin��86
products that increase testing efficiency Standalone and connected automation��40 Elecsys® Tg II��88
and to deliver medical value, whilst cobas p 312 pre-analytical system��41 Elecsys® Anti-TSHR��90
supporting you with our expert people cobas p 512 and cobas p 612 Elecsys® Vitamin D total��92
worldwide. pre-analytical systems��42 Elecsys® Anti-Mullerian Hormone (AMH)��94
cobas p 501 and cobas p 701 Elecsys® sFlt-1/PlGF��96
post-analytical units��44 Tina-quant® Hemoglobin A1c��98
MODULAR® PRE-ANALYTICS EVO��45 NEW The full SWA immunosuppressive
cy M
Total solution en Pioneer in
cobas® 8100 automated workflow series��46 drug assay panel��100
provider Personalized
ed
i
ic
ica
eff
Healthcare cobas® connection modules (CCM)��48

l val
Testing
Overview of Serum Work Area tests��50

ue
ECL – unique immunoassay technology��56

Personalized Comprehensive Turbidimetry – superior homogeneous Hemostasis testing�� 103
solutions for different and differentiated
throughput needs testing menu immunoassay technology��58 NEW cobas t 411 coagulation analyzer��104
Diagnostics excellence in Multiplate® analyzer��106
Pa r t
n ership Infectious Diseases��60
The Roche Hepatitis diagnostic portfolio��62
Global and local Commitment Elecsys® HIV combi PT
experts in >130 and innovation 4th Generation (Ag+Ab test)��64
countries for diagnostics
The Syphilis test panel��66
Elecsys® Syphilis immunoassay�� 67
8|9
Urinalysis�� 109 COBAS® AmpliPrep/ Point-of-care testing�� 177 Hematopathology diagnostics��228
Urinalysis from Roche�� 110 COBAS® TaqMan® HIV-1 Test, v2.0��139 Overview of point-of-care Lung cancer diagnostic solutions��230
Micral-Test® strip for albumin in urine�� 111 COBAS® AmpliPrep/ diagnostic tests��178 Prostate cancer diagnostics��232
Combur-Test® strip��112 COBAS® TaqMan® HBV Test, v2.0��141 cobas® POC IT solution��181 Connectivity solutions��233
Urisys 1100 analyzer��113
®
COBAS AmpliPrep/
®
NEW cobas® infinity POC mobile��184 VANTAGE workflow solution��234
cobas u 411 urine analyzer��114 COBAS® TaqMan® CMV Test��143 cobas® bge link software��186 Companion diagnostics��236
cobas® 6500 urine analyzer series��116 COBAS® TaqMan® MTB Test��145 cobas b 221 system��188 Digital pathology��238
LightCycler® MRSA Advanced Test��147 cobas b 123 POC system��190
cobas® 6800/8800 Systems��148 Accu-Chek® Inform II solution��192
cobas 4800 System��150
®
cobas h 232 POC system��194
Molecular diagnostics�� 119 COBAS® AmpliPrep/ Roche CARDIAC® Trop T Sequencing solutions�� 241
Molecular diagnostics solutions��120 COBAS® TaqMan® System��152 Sensitive test��196 Genome Sequencer FLX+ System��242
Test Overview��122 cobas® Liat System��154 CoaguChek® XS system��198 GS Junior System��244
cobas® HPV Test��124 cobas s 201 System��156 CoaguChek® Pro II system��200 NimbleGen sequence capture��246
cobas® Oncology Portfolio��126 NEW FLOW Solution��158 Accutrend® Plus system��202
cobas HSV 1 and 2 Test��128
®
LightCycler Systems��160
®
Reflotron® Plus system and
cobas Cdiff Test��130
®
LightCycler 2.0 Instrument��162
®
Reflotron® Sprint systems��204
cobas® MRSA/SA Test��131 MagNA Pure Systems��164 cobas b 101 system��206 Consultancy services�� 249
NEW cobas® HCV for use on cobas p 480 instrument��166 Consultancy services��250
the cobas 6800/8800 System��132
®
cobas p 630 instrument��168
NEW cobas® HCV for use on cobas p 680 instrument��170
the cobas® 4800 System��133 Tissue diagnostics�� 209
NEW cobas® HCV Genotyping Tissue diagnostics��210 Roche DiaLog�� 253
for use on the cobas® 4800 System��134 NEW VENTANA HE 600 system��212 Roche DiaLog��254
COBAS® AmpliPrep/ Roche Blood Safety Solutions�� 173 BenchMark Special Stains��214
COBAS® TaqMan® HCV qualitative NEW Roche Blood Safety solution�� 174 BenchMark IHC/ISH platform��216 Trademarks�� 256
and quantitative Tests, v2.0��135 IHC detection��218
NEW cobas® HIV-1 for use Primary antibodies��220
on the cobas® 6800/8800 System ��137 Breast cancer diagnostics��223
NEW cobas® HIV-1 for use on Cervical disease diagnostics��224
the cobas 4800 System��138
®
Colorectal diagnostics��226
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Serum Work Area solutions

Immunochemistry Laboratories have to manage critical work-
flow processes and provide uninterrupted
Roche’s flexible cobas IT systems include
middleware applications, laboratory infor-
Clinical chemistry service. Our cobas® platforms offer fully

harmonized end-to-end solutions covering
mation systems and hospital point-of-care
solutions. They enable you to use your
Laboratories
everything from sample entry to result resources more effectively, while monitoring
reporting and archiving. With their scalable laboratory performance and increasing
modular design, they can be customized quality and confidence.
IT solutions to meet any laboratories needs.

Our innovative and comprehensive
Elecsys Roche’s automated pre- and post-analytical

solutions are integral to providing complete
test portfolio meets demands for workflow
consolidation while also addressing
SWA solutions flexibility and process optimization. We offer

a full array of stand-alone and networked
previously unmet medical needs. With our
ready-to-use reagents and Elecsys®
cobas solutions to meet all of your laboratories

needs. From laboratory layout to full imple-
mentation of systems and services, you can
immunoassay and DuREL homogeneous
assay technologies, we guarantee
high quality results, combined with proven
Pre- and post-analytics get everything from a single source. workflow convenience.
An integrated solution combining IVD and For more information please

IT reduces risk and complexity for your visit www.cobas.com
laboratory.
Instruments Automation
• Designed to
work together
• Easy onsite
upgradability
Reagents • Maximum IT Solutions
consolidation
• Future proof
12 | 13
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cobas® modular platform

www.cobas.com
Flexible family concept for tailor-made solutions
Today, laboratories are challenged to deliver Your benefit Product characteristics

reliable and high-quality diagnostics, while Increased efficiency • Flexible combinations of clinical chemistry
at the same time ensuring efficient analytical • Consolidation of 98 % or more of Serum (c) and immunochemistry (e) modules for
workflow. To meet these demands, Roche Work Area workload Serum Work Area or dedicated immuno-
has developed the cobas modular platform. • Consistent and predictable turnaround chemistry/clinical chemistry solutions
It is an intelligent and flexible s olution based times for smooth laboratory operation • More than 120 assays and applications on
on a common architecture that delivers • Further enhanced automation through a the clinical chemistry platform, ready-to-
tailor-made solutions for diverse workload broad offering of pre- and post-analytic use in cobas c packs
and testing requirements. The cobas and c
obas IT solutions from Roche • More than 100 assays on the immuno
modular platform is designed to reduce chemistry platform, ready-to-use in
the complexity of laboratory o peration and Reduced complexity cobas e packs
provide efficient and compatible solutions • Unique, ready-to-use reagents for maxi-
for network cooperation. mum convenience of handling, m inimal cobas® 8000 modular analyzer series >100 configurations
logistic effort and cost-effective operation Large volume
• Common look and feel of the user interface
Unique reagent concept for maximum of on all systems for reduced training time
handling convenience and minimal and flexible staff allocation
<c 702> <c 701> <c 502> <e 602>
logistic efforts
Consistent and fast patient results cobas 6000 analyzer series 7 configurations
• Standardized results across the entire Mid volume
obas modular platform ensured by using
c
the same reagents
• 9 min. STAT assays for superior support of <c 501> <e 601>
No mixing Ready to use Easy logistics emergency samples
No preparation Fail-safe Minimal storage cobas 4000 analyzer series 3 configurations
space
Reliable and future proven Low volume
• Proven Hitachi instrument reliability
ensures maximum uptime for economic
operation and reliable service to physicians
<c 311> <e 411>
• Over 30,000 cobas modular platform
system installations worldwide
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cobas® 8000 modular analyzer series

www.cobas.com
Intelligent LabPower
The cobas 8000 modular analyzer series Your benefit Consolidation

is designed for high workload laboratories Efficiency • Real tailor-made solutions for every lab
with a throughput of 2.5 to 15 million tests • Maximizes walk-away time and highly efficient change management
per year. A modular configuration consists • Optimizes cost management • Maximizes throughput and consolidation
of a core unit, an optional ISE unit (cobas • Improves sample turn-around time power without compromising workflow
ISE module), and up to four analytical and availability • Consolidates very frequently requested
modules: high throughput clinical chemistry tests with less frequently requested tests
modules (cobas c 702 and cobas c 701), Productivity
medium throughput clinical chemistry • Delivers throughput with maximum Product characteristics
module (cobas c 502) and the immuno- consolidation power • High speed: From 170 to 680 immuno
chemistry module (cobas e 602). • Manages peak times efficiently assay tests/hour and 2,000 to 9,800 • Multidimensional modularity: more than
• Increases sample capacity on board clinical chemistry tests/hour depending 100 configurations for tailored solutions
cobas 8000 modular analyzer series acts on configurations with fast on-site expandability
intelligently, empowering the laboratory Process innovation • Up to 280 reagent channels • More than 120 clinical chemistry and
to improve customer and patient services. • Ensures unrestricted rack traffic flow for almost 100 immunochemistry assays
intelligent sample routing
• Optimizes workflow Multidimensional modularity
• Provides confidence in results
Theoretical throughput (tests/hour, with ISE)
10,000
8,000
6,000
4,000
2,000
0
100 200 300
cobas 8000 modular analyzer series Reagent channels
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cobas® 8000 modular analyzer series
4a 4a
2 3 4 4 5 6
7 7 7 7
cobas 8000 modular analyzer series
1 cobas 8000 data manager 4 cobas c 702 module* 5 cobas c 502 module • Throughput of up to 170 tests/hour
• Traceability records, for easy tracking • More than 120 assays and applications on • More than 120 assays and applications on • 25 reagent channels directly accessible
of calibration and reagent information, the clinical chemistry platform including the clinical chemistry platform including for pipetting
offers more transparency substrates, enzymes, proteins, DATs, and substrates, enzymes, proteins, DATs, • Carryover-free disposable tips
• User-defined, fully automated, selective TDMs TDMs, and electrolytes • Clot, liquid level, and air bubbles detection
rerun and reflex testing • Throughput of up to 2,000 tests/hour • HbA1c (whole-blood measurement)
• 70 reagent channels directly accessible • Throughput of up to 600 tests/hour 7 Module sample buffer
2 Core unit for pipetting • 60 reagent channels directly accessible • Capacity for 20 sample racks resulting
• Loading capacity of 300 samples • Specimen integrity via serum indices, clot for pipetting in additional capacity of 100 samples
• Unloading capacity of 300 samples and liquid level detection • Automatic reagent loading and unloading per module
• Throughput of up to 1,000 samples/hour • Contact-free ultrasonic mixing during operation • Freely definable STAT positions
• Dedicated STAT port • Specimen integrity via serum indices, clot • Environmentally controlled compartment
• Optional sample rotation unit 4a Reagent manager and liquid level detection for 5 Auto QC racks
• 10 reagent positions • Contact-free ultrasonic mixing • Backup operation port
3 cobas ISE module • Reagent RFID reader • Switch gates for shortcuts; gripper for
• Sodium, potassium, and chloride • Continuous reagent cassette loading and 6 cobas e 602 module moving the racks from line to line
• 900 or 1,800 tests/hour unloading during operation • Heterogeneous immunochemistry testing • Random access to racks; racks can go
• ISE-specific sample probe with clot • Reagent cassette decapping with almost 100 assays for anemia, bone, from anywhere to everywhere
detection • Reagent cassettes can be placed in tumor markers, hormones, cardiac and
• Independent processing line the reagent manager at any time and infectious diseases
as convenient • 9 min. STAT applications for hsTnT,
* Alternatively, cobas c 701 module can be used. It is based on the same technology and it offers the same number of TnI, CK-MB, NT-proBNP, Myoglobin, PTH
channels as cobas c 702, but has no reagent manager function. and hCG
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cobas® 6000 analyzer series

www.cobas.com
The success story continues
The cobas 6000 analyzer series is a Your benefit Product characteristics First class performance
member of the cobas modular platform Increased efficiency High system reliability • State-of-the-art immunoassay testing
family. It offers medium to high workload • Perfect fit of throughput and reagent • More than 10,000 systems in operation using ECL technology
laboratories tailor-made solutions for channels achieved across the seven worldwide • High quality results by ensuring sample
clinical chemistry and immunochemistry different configurations • Proactive automated maintenance for and result integrity
testing. Depending on the configuration, • Consolidation of 98 % of the Serum over 96 % uptime including maintenance
the cobas 6000 analyzer series can be Work Area testing on a 24/7 basis Intelligent sample workflow
placed in laboratories processing up to • Simplified lab processes and reduced costs • Combines STAT with routine testing
2.5 million tests per year. The cobas 6000 Unique reagent concept without disruption
analyzer series is the result of vast know- Quality of results • No preparation and no mixing required,
how, and decades of experience, combined • That you can trust and are right the economic usage with high stabilities and Professional management
into one successful concept. With over first time convenient kit sizes of lab processes
10,000 systems in operation worldwide, • Predictable turnaround time • Wide range of pre- and post-analytical
the cobas 6000 analyzer series is the • Peace of mind solutions from small task target automa-
most successful SWA analyzer worldwide. tion to total lab automation
Maximum uptime
• Highly reliable system based on more Delivers customized solutions for various work and testing requirements
than 35 years of experience
Tests per hour
• Superior support provided by Roche
organizations worldwide 2,000
Optimized workflow 1,500
• Wide range of pre- and post-analytical

solutions and complete IT solutions 1,000
• Workflow efficiency and reduced

complexity 500
0
50 100 150
Channels
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www.cobas.com
The success story continues
True workflow consolidation Just as every patient requires individualized

care, every laboratory is unique. Striking a
2
balance between high standards and efficient
operation requires tailor-made solutions.
1 3 4 cobas p 312 pre-analytical system is

the ideal companion for the cobas® 6000
analyzer series, for a fully harmonized
and complete solution.
cobas 6000 analyzer series
1 Core unit • Throughput of up to 1,000 tests/hour Safe and efficient workflows with minimum The simplicity of this solution and the small
• Loading and unloading capacity of • 60 reagent channels directly accessible complexity, using a single square meter space requirements allow its easy imple-
150 samples for pipetting footprint. The cobas p 312 pre-analytical mentation in almost any laboratory.
• Throughput of up to 600 samples/hour • Automatic reagent loading and unloading system is Roche’s answer to fulfill automa-
• Dedicated STAT port during operation tion needs of many small to mid-sized The cobas p 312 pre-analytical system will
• Simple operation with continuous loading • Specimen integrity via serum indices, clot laboratories. It includes the necessary executes the following key tasks:
and unloading and liquid level detection functionality to significantly improve labo- • Sample registration at a single entry point
• Contact-free ultrasonic mixing ratory organization and increase workflow • Sorting and distribution of samples
2 Rack rotor efficiency. This on a single square meter. • Recursive workflow
• Capacity for 20 sample racks 4 cobas e 601 module • Archiving
• Freely definable STAT positions • More than 100 assays on the immuno-
• Option of three Auto QC racks chemistry platform including anemia,
• Random access for the racks bone, tumor markers, hormones, cardiac
and infectious diseases
3 cobas c 501 module • 9 min. STAT applications for hsTnT,
• ISE measurements (K, Na, Cl) TnI, CK-MB, NT-proBNP, Myoglobin, PTH
• More than 120 assays and applications and hCG
on the clinical chemistry platform • Throughput of up to 170 tests/hour
including proteins, enzymes, DATs, TDMs, • 25 reagent channels, directly accessible
substrates and electrolytes for pipetting
• HbA1c (whole-blood measurement) • Carryover-free disposable tips
• Clot, liquid level, and air bubble detection
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www.cobas.com
Freedom to realize your lab’s potential
The cobas 4000 analyzer series is a Your benefit Product characteristics cobas c 311 analyzer
member of the cobas modular platform Increased efficiency First class performance
family and designed for laboratories • Consolidation of 98 % or more of Serum • More than 120 assays and applications
processing 25,000 to 500,000 tests per Work Area workloads available including DATs, TDMs, specific
year or 50 to 250 samples per day. proteins and whole blood HbA1c
It consists of the c
obas c 311 analyzer Maximum uptime • Throughput: up to 300 tests/h; ISE: 150
for clinical chemistry and the cobas • Highly reliable system based on more samples/h (corresponding to 450 tests/h)
e 411 analyzer for immunochemistry than 35 years of experience
testing. Together with cobas infinity • Superior support by Roche organizations Intelligent sample workflow
standardized 3R (Request, Result, Reporting) worldwide • 108 sample positions with continuous
solution and the ability to integrate the random access and flexible STAT priority • Disposable tips and cups for carryover-
cobas p 312 pre-analytical system, the Quality of results settings free sample pipetting
cobas 4000 analyzer series provides a • Integrated safety features for results
comprehensive Serum Work Area solution you can trust Unique reagent concept Intelligent sample workflow
that brings workflow efficiency to the • Predictable turn-around time • Convenient and error-free handling • 75 sample positions (rack system)
next level. of c
obas c packs • 30 sample positions (disk system)
• Economic usage with high stabilities • Continuous random access and flexible
and convenient kit sizes STAT priority settings
Multiple LIS
High system reliability Unique reagent concept
• Programmable automated maintenance • Convenient and error-free handling
cobas infinity 3R virtual automation
functionalities of cobas e packs
• Economic usage with high stabilities
Product characteristics cobas e 411 analyzer and convenient kit sizes
First class performance
• More than 100 assays available High system reliability
• Throughput: up to 86 tests/h • More than 12,500 analyzers installed
• Superior immunoassay testing using worldwide
ECL technology • High uptime of 99.8 %
cobas p 312 cobas c 311 clinical cobas e 411 immunochemistry • 9 min. STAT applications including Troponin,
pre-analytical system chemistry analyzer analyzer (rack system) CK-MB, Myoglobin, ß-hCG and PTH
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cobas c 111 analyzer

www.cobas.com
Small box. Big performance.
The cobas c 111 analyzer is the smallest Your benefit Product characteristics
member of the cobas® serum work area High quality of results World-class performance
platform family and the ideal solution for • Comprehensive testing capabilities • More than 40 assays and applications
clinical chemistry testing in laboratories • Results you can trust the first time, available including whole blood HbA1c,
running ten to 50 samples per day. With a every time hsCRP, and D-dimer
comprehensive test menu and easy inte- • Externally rated world-class performance1
gration of STAT samples, it can support Increased efficiency
testing of both routine clinical chemistry • Essential routine testing on a small Good fit for labs <50 samples/day
panels and rapid turnaround critical care footprint • Throughput of up to 100 tests/hour
markers. In addition, the cobas c 111 • Simplified system operation • Compact benchtop system for labs with
analyzer uses the same reagent formula- limited floor space
tions as the larger cobas clinical chemistry Maximum uptime • Easy, intuitive software handling
analyzers. This standardizes patient results, • Highly reliable system delivering
which is vital to integrated laboratory net- > 99 % uptime High system reliability
works serving outpatient services, emer- • Superior support provided by Roche • Robust system design
gency departments and clinics, as well as organizations worldwide • Wizard-guided maintenance procedures
private laboratories serving primary care
physicians. Optimized workflow Network compatibility
• Reducing complexity for a range of labo- • Ability to connect to local IT environment
ratories, both networked or standalone • Common reagent chemistry across the
• Consistent results across the cobas cobas® platform
platform
cobas c 111 analyzer 1 Bowling, J.L., Katayev, A. (2010). Labmedicine, 41(7): 398-402.
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COBAS INTEGRA® 400 plus

www.cobas.com
The specialist in the routine laboratory
The COBAS INTEGRA 400 plus analyzer is Your benefit Product characteristics
the perfect solution for laboratories running High quality of results First class performance
50 to 400 samples per day. Its broad test • Results you can trust the first time, • More than 120 assays and applications
menu comprises over 120 assays and appli- and every time available including clinical chemistry,
cations that consolidate clinical chemistry specific proteins, TDMs, DATs and whole
with specific proteins, therapeutic drug Increased efficiency blood HbA1c
monitoring and drug abuse testing. This • Comprehensive testing capabilities on a
compact tabletop analyzer offers maximum compact footprint Good fit for labs processing
versatility to improve efficiency and reduce • Simplified processes and reduced costs 50 to 400 samples/day
costs. It uses the convenient cobas c pack • Throughput of up to 400 tests/hour
reagent f ormat, which standardizes patient Optimized workflow • Compact benchtop system for labs with
results across integrated laboratory networks. • Consistent results across the cobas® limited floor space
platform
High system reliability
• Robust system design
• Clot detection and pipetting safeguards
Unique reagent concept

• Convenient and error-free handling
of cobas c packs
• Economic usage with high stabilities
and convenient kit sizes
COBAS INTEGRA 400 plus
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cobas c 513 analyzer

NEW
www.cobas.com
Setting a new precedent in HbA1c lab efficiency
The prevalence of patients with diabetes Your benefit Product characteristics

has been significantly increasing in recent Manages high HbA1c workload Analyzer Reagents
years and is anticipated to rise by a further • Up to 400 HbA1c patient results/hour • High throughput of up to 400 HbA1c • Ready to use cobas c pack large
53 % until 2035. Managing the resulting patient results/hour • Tina-quant® HbA1c Gen. 3
growth of HbA1c testing volume is putting Fully automated and highly efficient • Test capacity of 14,000 determinations • Standardized according to IFCC
a strain on healthcare providers. workflow on board transferable to DCCT/NGSP
• Minimized operator intervention from • Closed tube sampling • Direct result reporting
The cobas c 513 analyzer is a dedicated sample registration to result delivery • No need for sample pre-mixing (in IFCC and NGSP units)
high throughput HbA1c solution designed • Closed tube sampling delivers maximum • Proven and trusted cobas technology
to cope with this increasing HbA1c testing safety to the operator • cobas link for remote services
volume. The analyzer offers a fully automated
and highly efficient workflow by delivering up Proven result reliability
to 400 patient results per hour, yet requiring • Standardized according to IFCC and
minimized operator intervention from transferable to DCCT/NGSP
sample registration to result delivery. Its • Delivers risk identification, diagnosis
closed tube sampling function delivers and monitors the level of HbA1c
maximum safety to the operator.
The cobas c 513 analyzer runs Roche’s

e stablished Tina-quant® HbA1c Gen. 3 test
which is standardized according to IFCC
and transferable to DCCT/NGSP in order
to ensure high quality and standardized
results. With no interference by most known
HbA1c variants, Roche’s Tina-quant HbA1c
assay delivers accurate risk identification,
diagnosis and monitors the level of
HbA1c delivering results that clinicians
and patients can trust.
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Automation & IT solutions

www.cobas.com
Personalized Lab Automation
At Roche, laboratory automation solutions 1. Virtual automation 1. Virtual automation

deliver the quality and reliability you To have the control you need, ensuring Workflow manager for your laboratory, consolidating Roche
cobas middleware solutions
expect, with the personalization required quality and efficiency across your lab, instruments, third-party instruments and host systems to enable
efficient sample and data flow
by low-, mid- and high-volume laboratories. virtual automation gives you the capability to
track your samples and reduce manual tasks Scalable IT solution that goes beyond workflow management and
cobas ® infinity IT solutions
With the most complete portfolio in the mar- through cobas IT solutions. operates across various lab disciplines. It provides modules
from connectivity, work area management and extended laboratory
ket, Roche's Personalized Lab Automation
IT functionality
provides the best customized solution for 2. Standalone automation
every lab. Pre- and post-analytical tasks are automated,
offering maximum efficiency through flexible 2. Standalone automation
standalone solutions. It significantly reduces Maximum efficiency in a minimal space. A compact solution with
cobas p 312 pre-analytical system
manual steps in the lab, enhancing error single point of entry for all lab disciplines, sorting, decapping and
archiving IVD test tubes
handling, safety and process quality.
cobas p 512/p 612 High throughput solutions for sorting, decapping, extensive sample
1. Virtual automation 3. Connected automation pre-analytical systems quality inspection, aliquoting, and re-capping of IVD test tubes
In addition to having all the benefits of Refrigerated archiving systems enabling automated sample retrieval
cobas p 501/p 701
standalone automation, connected auto- post-analytical units and add-on test management
mation offers transportation. Physically
connecting different instruments allows
for maximum predictability of time to 3. Connected automation
test results.
MODULAR® PRE-ANALYTICS EVO Consolidation of analytics and process organization through
integration of automation solutions
2. Standalone automation Hospital network
cobas® 8100 automated Fully automated solution featuring intelligent sample routing
workflow series and prioritizing STAT workflow
cobas® connection modules Designed for high throughput labs. Connection of flexible pre-
(CCM) analytical systems to analytical and post-analytics systems through
a fast track
3. Connected automation Commercial Independent

laboratories hospitals
3 Levels of Automation Customized solutions for every lab
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Intelligent workflow management
for your laboratory
cobas middleware solutions are the Your benefit Easily accessible management information
workflow manager for your laboratory, Effective use of your resources • Task-oriented for proactive exception
consolidating Roche instruments, • Manage your laboratory instruments management
third-party instruments and host systems and the people that use them from a • Sample archive management for automated
to enable e fficient sample workflows. single application or manual post-analytical phase
Different IT solutions are available to meet • Expert system allows you to focus on
regional customer needs (cobas IT critical information Save time and reduce duplication
middleware & cobas infinity IT solutions). * of effort
Improve quality performance • Configurable automated validation
The intuitive automated validation and • High level of traceability and transparency with multiple levels of expertise ensuring
quality control tools reduce operator through audit trail for each sample reproducible outcome
intervention, while allowing laboratory • Support to achieve compliance with • Task-oriented and easy-to-use
production to be monitored through regulations user interface
real-time dashboards.
Efficient workflows for today and
the future
Intelligent workflow management for your laboratory • Connects multiple instruments and soft-
wares, multiple LIS from multiple sites
• Scalable to follow the growth of your
organization
• Automated or manual pre-analytics and
Pre-analytical Analytical Post-analytical
post-analytics with complete traceability
Sample ID and Result generation Add-on test
tracking management
Helping to improve your quality processes
Sample preparation Quality control Archiving and retrieval • Quality control management including
multi-rules and drift control

* P lease check with your local Roche representative for
availability of the IT solution in your country.
34 | 35
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cobas® infinity IT solutions

www.cobas.com
One expert package to empower all
of your expertise
cobas infinity IT solutions is a web- cobas infinity IT solutions enables a Your benefit
based application with scalable modules paperless workflow, and is structured around Right solution for every environment
that are designed to manage complex work areas that focus on the tasks in hand. • Specialized modules designed for different
lab processes and give sample testing and The unique workflow engine removes the test disciplines – matching the structure
result data an efficient and transparent need to write complex rules to manage the and processes of different areas of the
flow. It automates the three main areas of sample automation. Autovalidation enables laboratory. It helps automate many manual
lab operations: pre-analytics, analytics efficient result management, and integrated tasks and optimizes productivity
and post-analytics; but also extends beyond quality management tools organize the • Scalable and expandable for every kind
the lab to ordering, blood collection quality process to support accreditation. of laboratory, now and in the future
validation and reporting.
Makes work flow • A comprehensive Integrated Quality
• The unique workflow engine drives Management tool that not only manages
Hospital network sample and data flow, streamlining job assay performance but also enables
tasks and optimizing all process your organization to improve overall quality
Hemato Urinalysis Micro
logy biology steps in the different levels of automation processes supporting accreditation
• Consistent look and feel across all
user interfaces help staff learn quickly and
POC SWA
Standalone Extended lab enables better communication in and
systems IT functionality
across disciplines including Point of Care
• Designed for easy of use on PC’s, tablets
Blood Pre/Post Specimen
safety analytics reception and mobile phones to see whats important
Standalone lab and act fast- from wherever you are
Flexile intelligence across lab disciplines and POC One decision for all choices – scalable to your needs
and work areas. again and again. Dynamic production monitoring
• Real time information for timely Designed to be easy to use, everywhere.
decision-making with the live view tool
• The Insights module retrieves retro
spective accessible data from all process
steps and turns the unsorted data
into meaningful statistical reports to
demonstrate lab performance
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cobas® infinity IT solutions

www.cobas.com
One expert package to empower all
of your expertise
cobas infinity central lab cobas infinity microbiology cobas infinity live view cobas infinity POC mobile
• Empowering lab experts to manage • Turns testing complexity into efficient • See what’s important • Always with you
complex processes workflow • Shares real time information for lab • A mobile application designed for POC
• Designed for labs to manage complex • Designed for work area and technicians and lab managers on coordinators in hospitals to keep
sample testing and result data flows in processes specific for microbiology. PC, tablets and mobile devices. While control and act on what is important
an efficient and transparent way It offers management of cultures, out of the office, laboratory users while away from their PCs
related biochemical testing and anti- can access valuable real-time information
cobas infinity central lab – 3R biotic susceptibility on turnaround time, sample load cobas infinity blood safety
• Standardized for request, result, and and delayed samples in a core lab • Part of the Roche Blood Safety Solutions
reporting in small labs cobas infinity total quality management • Optimizing process management and
• Pre-configured central lab module • Empowering management of a high level cobas infinity insights monitoring
for smaller labs for simple set-up with quality culture • Demonstrate your value as a trusted • Designed to increase workflow
basic functionalities • Designed for proactive documentation-, partner efficiency by optimizing the specific
issues-, indicators- and audits • Designed to turn objective lab statistics work area processes of the blood
management to achieve and maintain into meaningful information to improve donor testing environment
accreditation process performance and understand the
value of the lab
cobas infinity lab link

• Links health care professionals to your
lab, from order to result
cobas infinity central lab
• Connects customers with the lab to
streamline interactions when ordering
Ordering Blood Transport / Pre Analytics Validation Sample Reporting tests, checking patient results and
collection scan analytics archiving automating the collection process for
phlebotomists
Pre-analytical Analytical Post-analytical
Manages more than the complexity of lab operations.
38 | 39
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Standalone and connected automation cobas p 312

Personalized solutions for every lab pre-analytical system
Compact automation
www.cobas.com
for maximum efficiency
Your benefit cobas p 312 pre-analytical is a standalone

At an early pre-analytical stage, the solution offering maximum efficiency with
automation solutions from Roche perform minimal space requirements. In less than
a comprehensive inspection of sample 1 m2, cobas p 312 can be used for decap-
quality and volume, maximizing an overall ping, sorting and archiving IVD test tubes.
optimization of lab workflow through:
• Early error detection May be used to automate and simplify
• Reduced workload and reagents waste processes in clinical laboratories and blood
Standalone automation offers maximum efficiency • Shortest time to consistent results banks. This compact standalone solution
through flexible solutions that automate pre- and is validated for cross-contamination
post-analytical steps in the laboratory
Workflow your way compliance.
Personalized workflows enable you to
choose from primary, aliquot or mixed Product characteristics
workflow • Compact automation in less than 1 m2
• Primary sample workflow – if the focus • Throughput up to 450 samples/hour
is on cost efficiency • Registration of samples
• Aliquot workflow – if the focus is on • Selective decapping of samples
sample integrity and parallel testing • Archiving of samples
• Mixed workflow – to optimize the • Flexible and freely definable input/output
benefits of both sorting area
• Traceability and control of lab process
Short and predictable time to results
Connected automation, besides having all the benefits • Improving patient care by offering
of standalone automation, adds transportation by reliable results within predictable short
physically connecting pre-analytics, analytics and cobas p 312 pre-analytical system
post-analytics turnaround time, even during peak
workflows
40 | 41
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cobas p 512 and cobas p 612

pre-analytical systems www.cobas.com
Adapting to today’s needs.

Flexible for tomorrow’s demand.
Evolution of cobas p 512/612 pre-analytical • Tube type identification Product characteristics • Spin status detection:
systems – new and innovative standalone • Sample volume check • Freely definable input and output Detects if blood samples have been
solutions for high throughput laboratories. • Spin status detection sorting areas already centrifuged or not
cobas p 612 differs from cobas p 512 • Sample quality check • Input with capacity of 600 samples and • Early detection and sorting of tubes
due to the aliquot functionality. output of 1,200 samples with errors and issues
Flexibility • Connection to a bulk loader • Selective decapping of sample tubes
These standalone automation solutions Adapts to the lab’s sample handling needs. • Connection to single or double centrifuge • cobas p 612 includes an aliquoting
are validated for cross-contamination • A solution compatible with all lab disciplines • Handling of Roche and non-Roche racks section with barcode labelling of
compliance and therefore may be used to • Adapted sorting areas to your workflow and centrifuge buckets secondary tubes
automate and simplify processes in to stay flexible • Throughput up to 1,400 samples/hour • Sorting of tubes directly into analyzers
clinical laboratories and blood banks. • Single point of entry and bulk loading • Registration of primary samples target racks
of tubes for convenient sample loading • Orientation of barcode in a • Archiving of processed samples with
Your benefit • Long walk-away time “good-to-read” position optional recapping
Innovation • Tube type identification • Upgradeability to connected automation
The best answer to face emerging c hallenges • Sample volume and quality check
in laboratory operations.
• Upgradable to connected automation
• Easy to add functionalities
• Comprehensive inspection of sample
quality
• Increased productivity in the same
footprint
Quality comes first

The new generation of cobas p 512/612
perform a comprehensive inspection
of samples at an early stage, optimizing
the lab workflow and ensuring the best
use of time and resources.
cobas p 512 pre-analytical system Complete configuration: cobas p 612 pre-analytical system with
single centrifuge cobas p 471 and bulk loader module
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cobas p 501 and cobas p 701 MODULAR® PRE-ANALYTICS EVO

post-analytical units Pioneer in laboratory efficiency
The automated archive
www.cobas.com
Product characteristics • Identification of primary sample tubes MODULAR PRE-ANALYTICS EVO is

• Can be operated as standalone or • Automated storage, disposal and retrieval a modular system for the fully automated
connected to cobas® 8100, cobas of sample tubes processing of primary samples from centrif-
connection modules and MODULAR® • Selective recapping of tubes for storage ugation to archiving, including automated
PRE-ANALYTICS EVO • Selective decapping of tubes for retrieval delivery of samples to cobas® 6000 analyzer
• Storage throughput: up to 950 tubes/hour series and cobas 8000 modular analyzer
• Retrieval throughput: up to 70 tubes/hour series. There are three models, plus options
(retrieval, without influence on storage and upgrades to provide the greatest flexi
throughput) bility. Thus, MODULAR PRE-ANALYTICS
• Anytime easy access of samples due EVO meets a wide range of demands
to the walk-in refrigerator area with regard to sample throughput, Your benefit
• Storage capacity: laboratory layout, instruments connected Full automation
cobas p 501: 13,500 tubes and functionalities. • From sample entry to archive
cobas p 701: 27,000 tubes • Reduced biohazard risks for personnel
• Retrieval of samples within three minutes
after ordering Consolidation of analytics
• Reduced complexity with fewer analyzers
and fewer process steps
Process organization
• Streamlining of processes by providing IT
networking of all components along with
complete data and workflow management
Integration by automation
• Shorter, predictable TAT
• Reduction of labor-intensive processes
cobas p 501 post-analytical unit cobas p 701 post-analytical unit
44 | 45
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cobas® 8100 automated workflow series

www.cobas.com
3-D intelligence in lab automation
cobas 8100 intelligent tube transport • Primary sample workflow – if the focus
provides a short predictable time to results, is on cost efficiency
including prioritization for emergency • Aliquot workflow – if the focus is on
samples. With flexible workflows, early error sample integrity and parallel testing
detection and fully automated add-on • Mixed workflow – to optimize the benefits
handling, cobas 8100 allows for personalized of both
solutions to suit individual laboratory
needs, guaranteeing that quality comes first. Short and predictable time to results
• 3D intelligent tube transport improves Solution with cobas 8100 automated workflow series
cobas 8100 covers the needs of high- patient care by offering reliable results
throughput laboratories achieving 1,100 within predictably short turnaround times, Product characteristics
samples/hour. Designed with options for even during peak workflows cobas® 8100 is made up of three stations: needs in order to optimize the required
connectivity to Serum Work Area analyzers, • Multi-level and bidirectional tube transport: output, input and aliquot stations. Each workflow now. In the future, it can easily
hematology, coagulation, selective third- empty tube holders and holders with tubes station can be configured according to the grow as needed.
party analyzers and archiving, cobas 8100 run separately to avoid traffic jams number of samples and individual laboratory
fully automates the laboratory process • Tubes always have a clear destination and
from beginning to end. do not circle the track, guaranteeing first-
in first-out sample processing Output station Input station Aliquot station
Your benefit • Tubes can bypass modules if processing
Quality comes first is not required
At an early pre-analytical stage, Roche • Prioritized STAT workflow
automation solutions check the sample
quality and volume, maximizing workflow Flexible tube storage
efficiency. A solution with cobas 8100 offers 3 storage 1 2 3 4 5 6 7 8 9
• Early error detection concepts, ensuring fast access as soon as
• Reduced workload a tube is needed.
• No reagent waste • Short-term storage for an immediate re-run 1 Restopper flex-cap/screw cap 6 Sample check module
• Mid-term storage in the Add-on Buffer 2 Add-on/output buffer 7 Destopper
Workflow your way Module – for optimized add-on request 3 Output buffer/sorter 8 Barcode labeler/tube feeder
Personalized workflows enable you to choose processing within the same day 4 Input buffer 9 Aliquot module
from primary, aliquot or mixed workflow. • Long-term storage 5 Automatic centrifuge unit
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cobas® connection modules (CCM)

www.cobas.com
Everything designed to work together as one
cobas connection modules (CCM) allow Quality comes first • Adapted sorting areas to your workflow
the connection of the standalone automation CCM performs a comprehensive inspection to stay flexible. Automates sorting areas
systems, cobas p 512 and cobas p 612, of samples at an early stage, optimizing also for non-connected work areas
to analytics and post-analytics through a the lab workflow and ensuring the best use • Long walk-away time
fast track. of time and resources. • Flexibility of layouts with the possibility
• Tube type identification to easily adapt for future changes
You can still take advantage of the huge • Sample volume check
flexibility of the standalone automation • Spin status detection Possible solutions
concept, while adding predictability of time • Sample quality check The fast track to sample flow efficiency
to results by getting connected through CCM connects pre-analytical system to
cobas® connection modules. Workflow your way multidisciplinary targets streamlining and
Personalized workflows enable you to optimizing laboratory processes.
Your benefit choose from primary, aliquot or mixed
Multidisciplinary connectivity workflow. CCM is a connected automation
• Serum Work Area – cobas® 6000/8000 • Primary sample workflow – if the focus solution validated for cross-contamination
analyzer series, MODULAR® ANALYTICS is on cost efficiency compliance and therefore may be used
• Hematology – Sysmex HST/XN-9000 • Aliquot workflow – if the focus is on to automate and simplify processes in clinical
hematology analyzers sample integrity and parallel testing laboratories and blood banks.
• Coagulation – Stago STA-R Evolution® • Mixed workflow – to optimize the benefits
Expert Series System and Stago STA-R of both workflows Combined forces for maximum value
Max® System CCM can connect a cobas p 512/612
• Urinalysis – cobas® 6500 urine analyzer Flexibility pre-analytical systems to MODULAR
series Adapts to the lab’s sample handling needs. PRE-ANALYTICS EVO. This combination
• Molecular Diagnostics – cobas® 6800/ • A solution compatible with all lab makes it possible to maximize the
8800 system disciplines throughput of existing MPA systems, add
• Post-analytics – cobas p 501/701 post- • Single point of entry and bulk loading of new features and connections.
analytical unit tubes for convenient sample loading
Please note that not all versions are distributed in all countries. For further details contact your local affiliate.
48 | 49
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Overview of Serum Work Area tests

www.cobas.com
COBAS INTEGRA®
COBAS INTEGRA®
COBAS INTEGRA®
COBAS INTEGRA®
platform: e module
platform: e module
platform: e module
platform: e module
platform: c module
platform: c module
platform: c module
platform: c module
cobas® modular
cobas® modular
cobas® modular
cobas® modular
cobas modular
cobas modular
cobas modular
cobas modular
cobas c 111
cobas c 111
cobas c 111
cobas c 111
400 plus
400 plus
400 plus
400 plus
analyzer
analyzer
analyzer
analyzer
Anemia CK-MB • • • Drugs of Abuse Testing Calcitonin •
Ferritin • • • CK-MB (mass) • Amphetamines (Ecstasy) • • Cortisol •
Folate • CK-MB (mass) STAT • Barbiturates • • C-Peptide •
Folate RBC • CRP hs • • • Barbiturates (Serum) • FT3 •
Iron • • • Cystatin C • • Benzodiazepines • • FT4 •
Iron binding capacity D-Dimer • • • Benzodiazepines (Serum) • hGH •
– Unsaturated • • Digitoxin • • • Cannabinoids • • Hydroxybutyrate • •
Soluble transferrin receptor • • Digoxin • • • Cocaine • • Dehydrogenase
Transferrin • • GDF-15 5 • Ethanol • • IGF-14 •
Vitamin B12 • HDL Cholesterol direct • • • LSD • 2
• Insulin •
Lactate Dehydrogenase • • • Homocysteine • • • Methadone • • Lipase • • •
Bone Hydroxybutyrate Dehydrogenase • • Methadone metabolites • • PTH STAT •
Calcium • • • LDL Cholesterol direct • • • (EDDP) T3 •
N-MID Osteocalcin • Lipoprotein (a) • • Methaqualone • • T4 • •
P1NP • Myoglobin • • • Opiates • • Thyreoglobulin (TG II) •
Phosphorus • • • Myoglobin STAT • Oxycodone • 3
• Thyreoglobulin confirmatory •
PTH • NT-proBNP • Phencyclidine • • TSH •
PTH (1-84) • NT-proBNP STAT • 1
Propoxyphene • • T-uptake • •
b-CrossLaps • Troponin I • 1
Endocrinology Fertility
Vitamin D total • Troponin I STAT • Amylase – pancreatic • • • Anti-Mullerian Hormone •
Cardiac Troponin T hs • Amylase – total • • • DHEA-S •
Apolipoprotein A1 • • Troponin T hs STAT • ACTH • Estradiol •
Apolipoprotein B • • Coagulation Anti-Tg • FSH •
Cholesterol • • • AT III • • Anti-TPO • hCG •
CK • • • D-Dimer • • • Anti-TSH-R • hCG plus beta •
1
Not on cobas e 411 3
Not on cobas c 701 and c 702 5
Launch in 2016 Please check with your local Roche representative for
2 Not on cobas c 311 4 In development 6 Only on cobas c 501 and c 502 availability of the assays and tests in your country.
50 | 51
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www.cobas.com
COBAS INTEGRA®
COBAS INTEGRA®
COBAS INTEGRA®
COBAS INTEGRA®
platform: e module
platform: e module
platform: e module
platform: e module
platform: c module
platform: c module
platform: c module
platform: c module
cobas® modular
cobas® modular
cobas® modular
cobas® modular
cobas modular
cobas modular
cobas modular
cobas modular
cobas c 111
cobas c 111
cobas c 111
cobas c 111
400 plus
400 plus
400 plus
400 plus
analyzer
analyzer
analyzer
analyzer
LH • Anti-HBc IgM • Inflammation Metabolic
Progesterone • Anti-HBe • Anti-CCP • Bicarbonate (CO2) • • •
Prolactin • HBeAg • ASLO • • Calcium • • •
SHBG • Anti-HBs • C3c • • Chloride • • •
Testosterone • HBsAg • C4 • • Fructosamine • •
Hepatology HBsAg confirmatory • Ceruloplasmin • • Glucose • • •
Alkaline phosphatase (IFCC) • • • HBsAg quantitative • CRP (Latex) • • • HbA1c (hemolysate) • • 3
•
ALT/GPT with Pyp • Anti-HCV • Haptoglobin • • HbA1c (whole blood) • • 3
•
ALT/GPT without Pyp • • • Chagas 4
• IgA • • Insulin •
Ammonia • • • CMV IgG • IgE • Lactate • • •
AST/GOT with Pyp • • • CMV IgG Avidity • IgG • • Magnesium • • •
AST/GOT without Pyp • • • CMV IgM • IgM • • Potassium • • •
Bilirubin – direct • • • HIV combi PT • Immunglobulin A CSF • Sodium • • •
Bilirubin – total • • • HIV-Ag • Immunglobulin M CSF • Total Protein • • •
Cholinesterase Acetyl • 3
HIV-Ag confirmatory • Interleukin 6 • Triglycerides • • •
Cholinesterase Butyryl • • HSV-1 IgG • Kappa light chains • • Triglycerides Glycerol blanked •
Gamma Glutamyl Transferase • • • HSV-2 IgG • Kappa light chains free • 6
• Vitamin D total •
Glutamate Dehydrogenase • • HTLV-I/II • Lambda light chains • • Oncology
HBeAg • Rubella IgG • Lambda light chains free • 6
• Acid phosphatase • •
HBsAg • Rubella IgM • Prealbumin • • AFP •
Lactate Dehydrogenase • • • Syphilis • Procalcitonin • CA 125 •
Infectious diseases Toxo IgG • Rheumatoid factor • • CA 15-3 •
Anti-HAV • Toxo IgG Avidity • a1-Acid Glycoprotein • • CA 19-9 •
Anti-HAV IgM • Toxo IgM • a1-Antitrypsin • • CA 72-4 •
Anti-HBc • TPLA (Syphilis) • 6
1
Launch in 2016 Please check with your local Roche representative on
52 | 53
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www.cobas.com
COBAS INTEGRA®
COBAS INTEGRA®
COBAS INTEGRA®
COBAS INTEGRA®
platform: e module
platform: e module
platform: e module
platform: e module
platform: c module
platform: c module
platform: c module
platform: c module
cobas® modular
cobas® modular
cobas® modular
cobas® modular
cobas modular
cobas modular
cobas modular
cobas modular
cobas c 111
cobas c 111
cobas c 111
cobas c 111
400 plus
400 plus
400 plus
400 plus
analyzer
analyzer
analyzer
analyzer
Calcitonin • PTH (1-84) • Primidone • PAPP-A •
CEA • Total Protein • • • Procainamide • • PlGF •
Cyfra 21-1 • Total Protein, Urine/CSF • • Quinidine • • sFIt-1 •
hCG plus beta • Urea/BUN • • • Salicylate • • P1NP •
HE4 • Uric acid • • • Sirolimus • Progesterone •
Kappa light chains free • 6
• a1-Microglobulin • • Tacrolimus • Prolactin •
Lambda light chains free • 6
• b2-Microglobulin • Theophylline • • SHBG •
NSE • Therapeutic drug monitoring Tobramycin • • Testosterone •
proGRP • Acetaminophen (Paracetamol) • • Valproic acid • CMV IgG •
PSA free • Amikacin • • Valproic acid free • CMV IgG Avidity •
PSA total • Carbamazepine • • Vancomycin • • CMV IgM •
SCC • Cyclosporine • • Women's health Rubella IgG •
S-100 • Digitoxin • • • Anti-Mullerian Hormone • Rubella IgM •
Thyreoglobulin (TG II) • Digoxin • • • AFP • Toxo IgG •
Thyreoglobulin confirmatory • Everolimus • b-Crosslaps • Toxo IgG Avidity •
b2-Microglobulin • Gabapentin6 • DHEAS • Toxo IgM •
Renal Gentamicin • • Estradiol •
Albumin (BCG) • • • Lidocaine • FSH •
Albumin (BCP) • • Lithium • ISE free ßhCG •
Albumin immunologic • • • Methotrexate6 • hCG •
Creatinine (enzymatic) • • • Mycophenolic acid • • hCG plus beta •
Creatinine (Jaffe) • • • NAPA • • hCG STAT •
Cystatin C • • Phenobarbital • • HE4 •
Potassium • • • Phenytoin • • LH •
PTH • Phenytoin free • N-MID Osteocalcin •
1
Launch in 2016 Please check with your local Roche representative on
54 | 55
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ECL – unique immunoassay technology

www.cobas.com
Still light years ahead
ECL (ElectroChemiLuminescence) is Roche’s Your benefit Product characteristics

technology for immunoassay detection. Rapid response times ECL is an innovative technology with Elecsys® diagnostic markers with
Based on this technology and combined • 93 % of assays with 18 min. assay time distinct advantages advanced assay design
with well-designed, specific and sensitive or less • Extremely stable non-isotopic label for • Robustness against interference
immunoassays, our Elecsys® tests deliver • 9 min. STAT applications for emergency long onboard stability and economic use (e.g. HAMA) due to a multidimensional
reliable results. The development of ECL samples of reagents approach: blocking proteins, fragmented
immunoassays is based on the use of a • High sensitivity for patient-friendly low catcher or tracer antibodies or chimeric
ruthenium complex and tripropylamine. Wide measuring range sample volumes and fast results due to antibodies
The chemiluminescence reaction for detec- • Linear signal response over six orders short turnaround times • Reference-traceable results with high
tion of the reaction complex is initiated by of magnitude • Broad measuring range for fewer repeats lot-to-lot stability allow accurate long-
applying a voltage to the sample solution and a streamlined workflow term monitoring
resulting in a precisely controlled reaction. Low sample volume • High precision over the entire measuring • Unique reagent concept with ready-to-use,
ECL technology can accommodate many • High analytical sensitivity allows low range for reliable results fail-safe and convenient reagent packs
immunoassay principles while providing s ample volumes • Applicable for the detection of all analytes (cobas e pack) for consistent handling
superior performance. • Patient-friendly 10 – 50 μL per test for a broad assay menu including innova- • Consistently precise results across
tive markers obas® immunochemistry platforms
c
Controlled reaction based on standardized reagents and
• High on-board stability and long shelf-life low inbuilt variability
due to highly stable constituents
ElectroChemiLuminescence (ECL) technology
Precision and sensitivity
• Superior low-end detection limits
• Excellent precision over the entire
measuring range
Attach Attach p ara- Attach to Voltage Signal count

ruthenium magnetic electrode; starts
microbead bound/free reaction
separation
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Turbidimetry – superior homogeneous

immunoassay technology
Integrate specific protein testing into
your routine
Turbidimetry setting new standards: Your benefit Product characteristics

Consolidation without compromise Efficiency and accelerated result re- Turbidimetry is Roche’s technology for
The testing of “specific proteins” continues porting homogeneous immunoassay detection.
to be one of the key routines in laboratories • High throughput without the associated Continuous development of the classical
due to their wide-ranging clinical utility. cost of a dedicated instrument for protein antigen-antibody assay design to the pat-
In the past, specific proteins were analyzed assays ented DuREL (Dual-radius enhanced latex)
using a variety of specialized methods, • High sample throughput capability and technology forms the b asis for high sensi-
such as radial immunodiffusion, immuno- no sample split tivity and broad dynamic range detection.
electrophoresis or using dedicated nephe- • Most efficient assay usage with high
lometers. This incremental investment and onboard stability and low calibration The use of bichromatic wavelengths in
the resulting additional costs, handling frequency spectrophotometry in conjunction with the
complexity and reductions in throughput measurement of a sample blank minimizes
were accepted due to the perceived benefits Consolidation without compromise interference effects.
in performance offered by these methods. • Broadest specific protein menu on a fully
consolidated platform including open Technological advances and future-oriented assay design
Today, specific protein determinations are channel offering
frequently carried out on consolidated, • Broad system platform portfolio for
random-access clinical chemistry systems every lab size with standardized reagents
using turbidimetric technology. Routine across the platforms
efficiencies such as reduced turnaround
times are thereby achieved for these
parameters.
Classical HIA Latex-enhanced HIA DuREL
Differently-sized particles working together
DuREL technology
Δ Absorbance
Radius I
Radius II
0 20 40 60 80 100 100 140 160

CRP concentration (mg/L)
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Diagnostics excellence in
Infectious Diseases
One step ahead
S D P S D P
Elecsys immunoassays Molecular assays
Anti-HAV total • • HBV DNA quantitative •
Roche Diagnostics offers a comprehensive The extensive infectious diseases portfolio Anti-HAV IgM • HCV RNA qualitative •
Viral hepatitis
portfolio of infectious diseases assays is expanding every year. We are not only HBsAg • • HCV RNA quantitative •
along the continuum of care, thereby en- focusing on launching new parameters
HBsAg confirmatory • HCV genotyping •
Viral hepatitis
abling laboratories to provide the right but we are also continuously updating
HBsAg quantitative • • HEV RNA qualitative •
Anti-HBs • • MPX (HIV/HCV/HBV) •
information, from screening and diagnosis our existing portfolio seeking continuous Anti-HBc • • DPX (B19V/HAV) •
to patient management and treatment improvement, as well as keeping pace Anti-HBc IgM • CT DNA • •
monitoring. with the evolution of pathogens. Anti-HBe • • CT/NG DNA • •
Our complete Infectious Diseases offer
HBeAg • • HSV1 and HSV2 DNA •
Anti-HCV • • HIV RNA quantitative •
STDs
includes serology and also molecular HIV combi PT • • HIV RNA qualitative • •
testing (please refer to chapter «Molecular HIV Antigen • HPV DNA •
Diagnostics» for more information) which, HIV Antigen confirmatory • HPV genotyping •
thanks to our Personalized Lab Automation Syphilis • • MPX (HIV/HCV/HBV) •
STDs
solutions can be configured, connected Syphilis TPLA • • CMV DNA quantitative • •
TORCH
and integrated to suit the requirements of Syphilis RPR • • •
any laboratory.
HSV-1 IgG • •
HSV-2 IgG • • C. Difficile DNA •
Each Roche Diagnostics infectious diseases HTLV-I/II • • MRSA DNA •
test is designed with a clinical benefit CMV IgG • • MRSA/SA DNA •
•
Others
in mind. A few examples that have been
CMV IgM • • MTB DNA
CMV IgG Avidity • MAI DNA •
described in scientific publications are: •
HSV-1 IgG • • Sepsis
• The Anti-HCV II and HIV Combi PT •
HSV-2 IgG • • VRE 2
excel in seroconversion sensitivity allowing Rubella IgG • • West Nile Virus •
TORCH
earlier intervention1-3 1 Combined data from “Study report: Performance Rubella IgM • • Part of the Roche Blood Safety Solutions panel
• Studies have confirmed the superior evaluation CE: Elecsys Anti-HCV II; 20 Feb.; Version2;
Study Number: CIM RD 001230/B10P010”
Toxo IgG • • 1 I n development
capability of HBsAg and HIV Combi PT to Penzberg, Germany. Toxo IgM • • 2
For research use only
detect mutants and rare variants, there- 2 Esteban, et al. (2013). J Med Virol. Toxo IgG Avidity •
3 Mühlbacher, et al. (2012). Med Microbiol Immunol.
fore driving screening effectiveness 4-7 Miller et al. (2010). (HIV).
Syphilis • • Please check with your local Roche representative on
• The CMV tests allow for a reliable 4 Ly et al. (2012). J Clin Virol. Syphilis TPLA • • the availability of the assays and tests in your country.
5 Mühlbacher, et al. (2008). Med Microbiol Immunol. 6. Syphilis RPR • • •
discrimination between an acute and a Jia, et al. (2009). Med Microbiol Immunol.
Chagas 1 • •
Others
7 Louisirirotchanakul, et al. (2010). J Med Virol.

remote infection, therefore preventing 8 Revello, M.G. et al. (2012). Eur J Clin Microbiol Infect
unnecessary repeat testing 8 Dis. (CMV)
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The Roche Hepatitis diagnostic portfolio

A clear direction ahead
Anti-HAV w v
HAV
Anti-HAV IgM
Every diagnostic test – from the initial many major reference and clinical research
screening through to viral load testing – laboratories using Roche hepatitis products HBsAg II HBsAg II quant II
can empower viral hepatitis treatment and services.
decisions and improve patient outlook. Anti-HBc IgM Anti-HBs
Not surprisingly, Roche customers regularly
HBsAg Anti-HBe
Roche offers the cobas® family of diagnostic leverage our experience as the provider confirmatory
platforms to run all the tests required for of high quality hepatitis immunoassays and
Anti-HBc HBeAg
HBV
the screening, diagnosis and management the most clinically validated hepatitis viral
of viral hepatitis. With more than 25 load assays worldwide. HBeAg HBV DNA
years of experience in the area of infectious quantitative
diseases, Roche covers all relevant From screening to patient management, Anti-HBe
diagnostic fields to help provide the best Roche’s diagnostic excellence and
patient care. Roche is in more laboratories efficiency provides answers today for a Anti-HBs
around the globe than any other vendor, with healthier tomorrow.
HCV RNA HCV genotyping* HCV RNA
qualitative quantitative
HCV
Anti-HCV II
Reticulum
Iron
General Hepatitis
A clear Trichrome
direction ahead
in hepatitis AFP
ALTLP GGT-2 AFP
Bilirubin
Roche Serum Work Area Roche Tissue Diagnostics

Roche Molecular Diagnostics *In development
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Elecsys® HIV combi PT

4th Generation (Ag+Ab test) www.cobas.com
Designed for early detection of HIV infection
The human immunodeficiency virus (HIV), Your benefit Product characteristics

the causative agent of the acquired immuno- Earlier detection of infection Elecsys® HIV combi PT test
deficiency syndrome (AIDS), belongs to the • Due to improved sensitivity by lysis of the characteristics
family of retroviruses. HIV can be trans- virus using a pre-treatment (PT) step • Indications: Diagnostic use and for
mitted through contaminated blood and screening of blood donations
blood products, through sexual contact or Compliant with recent international • Fast results: 27 min.
from an HIV infected mother to her child guidelines • Analytical sensitivity: ≤ 2.0 IU/mL
before, during and after birth. Reliable • Analytical sensitivity ≤ 2.0 IU/mL Human immunodeficiency virus type 1
screening and diagnosis constitutes a crucial (HIV-1 p24 antigen) – 1st International
aspect of the global strategy for reducing Robust to viral change Reference Reagent 1992, code 90/636
the human and financial burden of HIV • Multiple target concept to ensure excellent • Sample material:
transmission. inclusivity: special detection of HIV-1 – Serum, standard or separating gel tubes
subtypes, group O and HIV-2 antibodies – Plasma types: Li‑heparin, Na-heparin,
With the Elecsys HIV combi PT assay, the K2‑EDTA, K3‑EDTA, ACD, CPD, CP2D,
HIV-1 p24 antigen and antibodies to HIV-1 Cost efficiency CPDA, Na-citrate and Li‑heparin plasma
and HIV-2 can be detected simultaneously • High clinical specificity reduces the need tubes containing separating gel
in one determination. This leads to improved for repeat testing • Low sample volume: 40 μL
sensitivity and, therefore, a shorter • Clinical sensitivity: 100 % (n = 1,532)
diagnostic window as compared to anti-HIV Elecsys® ARCHITECT® HIV-1 group M, O and HIV-2
assays. The assay uses recombinant AxSYM® ADVIA® Centaur • Clinical specificity
antigens derived from the Env and Pol- PCR detection – Blood donors: 99.88 %
region of HIV-1 (including group O) and (95 % LCL: 99.77) (n = 7,343)
0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 Days
HIV-2 to determine HIV-specific antibodies. – Samples from unselected daily routine,
Mean seroconversion obtained using Ag/Ab assays
Specific monoclonal antibodies are used across different systems dialysis patients and pregnant women:
for the detection of HIV-1 p24 antigen. 99.81 % (95 % LCL: 99.62) (n = 4,103)
Comparison of the time required until acute infection
The test includes an automated sample can be detected using different HIV antigen/antibody
pretreatment step with detergent incubation combination immunoassays.1
in order to lyse HIV virions and maximize
exposure of the HIV p24 antigen to 1M ühlbacher, A. et al. (2012). Performance evaluation of a new fourth gen. HIV combination
increase sensitivity. antigen-antibody assay. Med. Microbiol. Immunol. DOI: 10.1007/s00430-012-0250-5.
64 | 65
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The Syphilis test panel Elecsys® Syphilis immunoassay

Fully automated for complete assessment Confidence in all stages of treponemal
of the disease syphilis infection
www.cobas.com
Syphilis is caused by the intracellular gram- Your benefit The Syphilis immunoassay has been
negative spirochete bacterium Treponema • Reliable and complete solution using your designed using the latest recombinant
pallidum subspecies pallidum. It is mainly algorithm of choice thermostable-antigen technology, to
transmitted sexually, but can also be • Integrated with other tests in the TORCH achieve unprecedented high sensitivity
transmitted from mother to fetus during and blood safety solutions portfolios and specificity performance across all
pregnancy or at birth, resulting in • Treponemal test suitable for screening in stages of infection.
congenital syphilis. Syphilis facilitates the the general population, pregnant women
acquisition of HIV. and blood donations Your benefit
Designed for high sensitivity
Roche offers an automated panel of • High sensitivity minimizes the probability
three assays for efficient and reliable of missing new infections Product characteristics
assessment of syphilis patients. • Serum, standard or separating gel tubes
Cost efficiency • Plasma types: Li-heparin, Na-heparin,
• High specificity reduces the need K2-EDTA, K3-EDTA, Na-citrate, ACD, CPC,
Treatment
Screening Diagnosis for re-testing CP2D, CPDA and K2-EDTA plasma tubes
monitoring
containing separating gel
• Syphilis • Syphilis • RPR
Clear results interpretation • Sample volume: 10 μL
• TPLA • TPLA
• RPR • RPR • Clear cut-off separation of positive • Assay time: 18 min.
and negative results • Test format: IgM/IgG (three antigens:
Panel for the complete assessment of the syphilis patient.
Screening, diagnosis, confirmation and activity monitoring of the disease. TpN15, TpN17, TpN47)
TPLA and RPR are SEKISUI, Japan products distributed by Roche. Efficient use of sample volume • Clinical sensitivity: 100 % (n = 924)
TPLA = T. pallidum Latex Agglutination • Maximizes the chance to order all the • Clinical specificity: 99.88 % (n = 8,079)
RPR = Rapid Plasma Reagin tests required from the same sample – Blood donors: 99.93 % (n = 4,579)
– Routine samples: 99.80 % (n = 3,500)
100 µL Vendor A
80 µL Vendor B
30 µL Vendor C
10 µL Elecsys® Syphilis
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Elecsys® TORCH panel

www.cobas.com
Reliable screening for early diagnosis
Infections with Toxoplasma gondii, Rubella Your benefit Product characteristics

virus, Cytomegalovirus (CMV) and Herpes High efficiency Roche has been continuously developing
simplex virus (HSV) are especially risky • Consolidation of TORCH panel on cobas® innovative TORCH assays. Based on recom-
during pregnancy. Prenatal diagnosis of immunology analyzers binant antigens and specific assay formats
such infections is important and demands such as μ-capture and DAGS (double
assays of outstanding quality and reliability. Early detection antigen sandwich), these assays combine
• Allows early management of acute high clinical sensitivity and specificity.
Opportunistic infections with Toxo and CMV congenital infections
can also have severe consequences for Elecsys® Toxo IgM, IgG and IgG Avidity
immunodeficient patients. A combination Fewer confirmation tests and • The Elecsys® Toxo IgM assay design and
of high clinical sensitivity and specificity is fewer reruns respective cut-off minimize the probability Elecsys® CMV IgM, IgG and IgG Avidity
therefore essential. • Due to highly specific assays of missing any new infection • Designed to detect all suspect primary
• The Toxo IgG detects past infections with infections
Fast reporting superior accuracy therefore immediately • Less sensitive to persistent IgM antibodies
• Results in less than 20 min. ruling out non-relevant cases • Prevents cross reactivity with other
• Combined use of the three assays herpes viruses
allows accurate determination of primary
Lower sensitivity to persistent IgM (not linked with a primary infection) infections Elecsys® HSV-1 IgG and HSV-2 IgG
• Identification of silent carriers of Herpes
Samples from pregnant women with positive CMV IgM values with routine assay but no Elecsys® Rubella IgM and IgG simplex virus infection
evidence of a recent primary CMV infection (high-avidity IgG titer). Clearly discriminates between an acute • Type-specific assays for reliable
and a remote infection differentiation between HSV-1 and HSV-2
Assay Site 1 (n = 20) Site 2 (n = 28) Site 3 (n = 20)
• Rubella IgG test ultrasensitive to remote (two Elecsys HSV IgG assays available)
Roche Diasorin ** Roche Siemens ** Roche Abbott **
infections
Elecsys Liaison Elecsys Enzygnost Elecsys Architect
• Complemented with early detection of
Positive
IgM */Total
6/20 20/20 4/28 28/28 7/20 20/20 acute infections by the Rubella IgM test
The combination of these assays provides

* Pos = Ind + Pos
** Routine method in the lab. an excellent tool for identifying and charac-
terizing Rubella infections.
R evello, M.G. et al. (2012). Eur J Clin Microbiol Infect. Dis. 31(12), 3331-9.
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Elecsys® Troponin T high sensitive (TnT hs)

www.cobas.com
Improved performance – better clinical decisions
In a clinical setting consistent with myo Your benefit Product characteristics

cardial ischemia, detection of a rise and/or Guideline compliant • Fully automated test
fall in troponin is the cornerstone of myo- • Test complies with the guidelines of ACC/ • Sample material: Heparin, EDTA plasma
cardial infarction diagnosis. The Elecsys ESC* and NACB/AACC** and serum
Troponin T hs test complies with the guide- • STAT test: 9 min.
lines of ACC/ESC* and NACB/AACC** Safe and reliable results • 99th percentile upper reference limit*:
in achieving less than 10 % coefficient of • Particularly at lower levels 14 ng/L (pg/mL)
variation (CV) at the 99 percentile upper • 10 % CV precision: 13 ng/L (pg/mL)
reference limit of the reference population. Earlier diagnosis
• Greater sensitivity allowing the detection
These requirements result in significant of more patients at risk Key benefit: Earlier diagnosis of AMI
dvantages in the diagnosis of acute
a Roche conventional cTnT Roche cTnT-hs
coronary syndrome (ACS): High prognostic value for cardiac events 100 Using the cTnT-hs assay, results in
Positive results (%)

• Significantly earlier detection of a cTn • Especially in patients with renal failure 80 NSTEMI compared with the conventional
increase during an acute myocardial 60 cTnT test report:
Time to diagnosis:
infarction (AMI) Early identification 40 ~ 3h shorter
• Time to diagnosis shorter by almost
• Earlier rule-out and rule-in of AMI • Of acute and chronic myocardial damage 20 with cTnT-hs three hours
• Increased number of patients correctly that would not be discovered at all or only 0 • 20 % more patients identified with a final
Admission 1 2 3 4 5 6
diagnosed with AMI, thanks to the greater later with conventional cTn assays Hours after admission
diagnosis of NSTEMI
sensitivity and better analytical precision
• Improved risk stratification of patients Consistent correlation Adapted from; Giannitsis, E. et al.Clin Chem (2010), 56(2), 254-261.
with elevated cTn levels without acute • Between POC devices for emergency The 2015 ESC guidelines for the management of acute coronary syndrome (ACS) without ST-segment elevation
officially endorse the use of cTnT-hs in rapid diagnostic algorithms (T0/1-h; and T0/3-h) for the early rule-out/
cardiac event testing and all cobas® immunoassay
rule-in of NSTEMI (Roffi, M. et al. (2015). Eur Heart J. [Epub ahead of print]).
analyzers in the central lab
These recommendations to adopt fast decision algorithms with hs troponin may help to reduce the hospitalization
time considerably (and thus costs) and to improve patient care.
* ACC/ESC: American College of Cardiology/European Society of Cardiology.

** NACB/AACC: National Academy of Clinical Biochemistry/Academy of the American Association
for Clinical Chemistry. * Elecsys® Troponin T high sensitive package insert.
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Elecsys® NT-proBNP
www.cobas.com
A leap forward in the diagnosis and
stratification of cardiovascular disease
Heart failure (HF) is a global health problem Your benefit Early diagnosis of HF
associated with high morbidity and mortality. Simplified testing process and • Even in early stages without symptoms
Detection in its early stages and appropriate improved efficiency of testing
treatment are key objectives in improving • NT-proBNP provides 72 hour room Objectivity
quality of life. Patients with HF – especially temperature stability without additional • NT-proBNP concentration correlates with
with mild symptoms – are often not diag- processing severity of disease
nosed. On the other hand, many patients • Test tube requirements allow one tube
with suspected heart failure are unneces- solution for all cardiac markers Strong prognosis
sarily referred to echocardiography. • High predictive value in cardiology risk
Consistent correlation patients
NT-proBNP is an innovative marker to im- • Between all cobas® immunoassay • Fast results: 9 min. as STAT assay
prove clinical decisions. It delivers accurate analyzers and POC devices Improved therapy • Longer sample stability: 3 days at room
data to help rule-out, rule-in, risk-stratify • Aids in the evaluation of the clinical temperature and even longer at 4° C
or monitor patients. Fast diagnosis situation and optimization of therapy • High test precision (CV 2.9 to 6.1 %)
• In cases of dyspnea; differentiation coupled with a wide dynamic measuring
between cardiac or pulmonary causes Product characteristics range (5 – 35,000 ng/L)
• Fully automated quantitative assay • Sample material: standard serum and
• Low sample volume: 50 μL heparin/EDTA plasma
Suspicion of acute heart failure because of symptoms and signs
NT-proBNP is formed by cleavage of proBNP

Examination, ECG, X-ray and NT-proBNP
pre-proBNP
Patient age (Years) NT-proBNP values (pg/mL)
Heart
< 50 <300 300 – 450 >450 proBNP muscle
50 –75 300 – 900 >900
>75 300 –1800 >1800
N-terminal proBNP BNP

Interpretation Acute HF unlikely Acute HF less likely, Acute HF likely, consider
alternative causes must confounding factors Half life 120 min. 20 min.
Myocardial
be considered
stretch and strain
NPV = 98 % PPV = 92 % Blood
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Lp(a), hsCRP and Homocysteine

www.cobas.com
Improving cardiovascular risk assessment –
allowing better treatment decisions
Cardiovascular disease (CVD) is a major • Official guidelines recommend using Lp(a), Your benefit Consolidation
health burden: a high proportion of hsCRP and Homocysteine, in combination Testing efficiency • Accurate and reliable measurement
patients are not classified correctly or even with conventional risk analysis to aid in the • Cost-effective, fast, robust, easy to on a fully consolidated platform
missed entirely for cardiovascular (CV) evaluation of CV risk assessment.2–4 This perform with excellent accuracy and
risk assessment leads to a more accurate categorization precision due to advanced assay design
• Up to 70 % of those who develop coronary of individuals at increased risk for CV
events have only one, or even none of the disease 5 (figure 2) Standardization 1 Young, I., Rifai, N. (2009). Clin Chem. 55, 201– 2 .
traditional risk factors, and more than half • Consistent patient results across all care 2 N ordestgaard, B.G. et al. (2010). Eur Heart J.
31(23), 2844–53.
have either normal or mildly increased settings due to standardized reagents on
3 Perk, J. et al. (2012). Eur Heart J. 33(13), 1635 – 701.
lipid values1 (figure 1) all Roche systems 4 R efsum, H. et al. (2004). Clin Chem. 50, 3–32.
• Excellent correlation to the reference 5 M ontgomery, J.E., Brown, J.R. (2013). Vasc Health
method/material Risk Manag. 9, 37– 4 5.
Figure 1: Only up to 70 % of cases can be identified
Product characteristics
Assay Tina-quant® Homocysteine Cardiac C-Reactive
Lipoprotein (a) Gen. 2 enzymatic Protein High Sensitive
Sample material Serum, Plasma Serum, Plasma Serum, Plasma

LDL HDL Sample volume 2 µL 14 µL 6 µL
Assay time 10 min. 10 min. 10 min.
Cholesterol Smoking Blood pressure Age Gender Weight Height
Measuring range 7– 240 nmol/L 3 – 50 µmol/L 0.15 – 20 mg/dL
Onboard stability 42 days 28 days 84 days
Figure 2: 90 % of cases can be identified Calibration frequency With every lot With every lot With every lot
Precision
(cobas c 501 module)
- Repeatability 0.8 – 5.6 % 1.4 – 2.0 % 0.4 –1.6 %
- Intermediate precision 1.1– 8.0 % 1.8 – 2.3 % 2.1– 8.4 %
Traceability SRM2B for nmol/L NIST SRM 1955 BCR470/CRM470
HDL
+ HCY Lp(a) hsCRP
LDL
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Elecsys® IL-6, PCT and Tina-quant® CRP

www.cobas.com
For early and effective sepsis management –
because time matters
Sepsis, the systemic inflammatory response Your benefit PCT, IL-6 and CRP: a biomarker
to infection, is a leading cause of death. Rapid diagnostics panel to support early recognition
With 18 million global cases annually, it is • Short total assay time and management of sepsis
a major burden on healthcare. IL-6: Early warning sign of (systemic)
Testing efficiency inflammation and sepsis
Early recognition is critically important • All parameters from one sample tube PCT: Follows IL-6 and indicates high
for patient survival, but clinical signs and probability of bacterial sepsis
symptoms are often ambiguous. Economical sample handling CRP: Released from the liver as a later
• Low sample volumes, especially important marker of inflammation
Elecsys IL-6, Elecsys BRAHMS PCT, in for pediatrics
combination with CRP, deliver rapid, reliable Product characteristics
information about the patient’s immediate Assay Elecsys BRAHMS PCT Elecsys IL-6 CRPL3 on
inflammatory status and likelihood of cobas c analyzers
bacterial sepsis, which is important for Sample material Serum, Li-heparin and Serum, Li-heparin Serum, Li-heparin and
K 3-EDTA plasma and K 2- and K 3-EDTA K 2- and K 3-EDTA plasma
antimicrobial therapy management. plasma
Sample volume 30 µL 30 µL 2 μL
Assay time 18 min. 18 min. 10 min.
Acute inflammatory Clinical indication Differential Severe sepsis/shock Measuring range 0.02 – 100 ng/mL 1.5 – 5,000 pg/mL 0.3 – 350 mg/L
episode of sepsis diagnosis
Analytical sensitivity <0.02 ng/mL 1.5 pg/mL 0.3 mg/L
Suspicion/treatment characterization Therapy stewardship
of infection* Functional sensitivity <0.06 ng/mL 5 pg/mL 0.6 mg/L
Traceability Standardized against WHO Standard NIBSC IRMM reference prepa-
• IL-6 • Temperature • Blood culture • PCT
– PCT BRAHMS PCT LIA 1st IS 89/548 ration CRM470 (RPPHS)
• Heart rate • IL-6
• Breathing rate – IL-6
• Leukocytes – CRP
• CRP
* R apid identification of sepsis pathogens is possible with LightCycler® SeptiFast Test.
Please see on page 65 for more details.
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Elecsys® tumor marker portfolio

Supporting improvements in cancer diagnosis
and monitoring
In the last decade, the sensible use of Reliable results Roche reagent and application portfolio for consolidated tumor marker testing
tumor markers and the careful interpretation • Robustness against interference Test Cancer indications Roche/ COBAS cobas e MODULAR cobas c
of their results have led to the continuous (e.g. HAMA) by blocking proteins, Hitachi INTEGRA systems ANALYTICS systems
systems EVO
enhancement of their clinical significance. fragmented catcher or tracer antibodies
AFP Liver, testicles  
The inclusion of tumor markers in clinical or chimeric antibodies1
Calcitonin Medullary, thyroid carcinoma  
management can help to provide more • Standardized to international standards CA 125 Ovary  
information for improved clinical decision- or, if no standard available, traceable to HE4 Ovary  
making and therefore maximize the quality a commonly accepted methodology CA 15-3 Breast  
of care. Nowadays, therapy management of CA 19-9 Pancreatic, colorectal  
cancer patients is guided by tumor marker Operational efficiency CA 72-4 Gastric, colorectal,  
mucinous ovarian
measurements based on the individual • High degree of system automation
CEA Colorectal- and lung  
base line levels before and after primary • Less retesting due to high precision and adenocarcinoma
treatment. An excellent long-term assay wide measuring ranges CYFRA 21-1 Non small cell lung  
accuracy, lot-to-lot stability and precision is • Broad tumor marker menu with specialties Ferritin Tumor related anemia     
crucial for the reliable evaluation of signifi- such as CA72-4, S100, NSE, CYFRA 21-1, HCG Chorion  
ß2 Microglo- Multiple myeloma    

cant differences in tumor marker levels in HE4, and ProGRP
bulin (non-Hodgkin)
cancer patients during therapy monitoring • Outstanding degree of SWA consolidation NSE Small cell lung  
and follow up. with > 210 parameters for clinical chemistry ProGRP Small cell lung  
and immunochemistry SCC Squamous cell lung, cervix  
Your benefit Free PSA Prostate  
Longitudinal accuracy for reliable Complete diagnostic picture with Total PSA Prostate  
S100 Malignant melanoma  

long-term patient monitoring Personalized Healthcare
Anti-TG Medullary, thyroid carcinoma  
• High reproducibility and analytical • Coverage of the whole chain from
Tg II (hs) Medullary, thyroid carcinoma  
precision over the entire measuring range, diagnostics, therapy decision and moni-
especially in lower concentration ranges toring by Roche’s broad oncology menu
• High lot-to-lot consistency across all in tissue diagnostics, Elecsys tumor
cobas® platforms markers and molecular solutions
1 B olstad, N. et al (2011). Heterophilic antibody interference in commercial immunoassays.

Clin Chem Lab Med 49(12), 2001-2006.
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Elecsys® HE4
www.cobas.com
An oncological biomarker improving ovarian
cancer care
Worldwide, ovarian cancer is the second Your benefit ROMA increases the diagnostic value Product characteristics
leading cancer in women and the fourth Early marker with increased sensitivity of the dual marker combination HE4 • Assay time: 18 min.
most common cause of death from cancer. for supporting the diagnosis of epithelial and CA 125 • Sample material: Serum collected using
It is a gynecological disease with one of ovarian cancer (EOC) Measured values of HE4 and CA 125 can standard sampling tubes or tubes con-
the highest mortality rates. • As a single tumor marker, HE4 had the be combined in an algorithm called ROMA taining separating gel Li-heparin plasma,
greatest sensitivity (at a specificity of — which takes into account the menopausal K2-EDTA and K3-EDTA plasma
The more the disease has progressed, the 75 %) in detecting of EOC, especially in status of the woman. Several published • Sample volume: 10 μL
lower the survival rate is and unfortunately the early non-symptomatic stage studies show that ROMA helps in the triage • Limit of detection: 15 pmol/L
most cases of ovarian cancer are d etected of pre- and postmenopausal women sus- • Measuring range: 15 – 1,500 pmol/L
in later stages where the chances of cure High discrimination between benign pected of having ovarian cancer. Moore et • Intermediate imprecision cobas e 411
are rather low. ovarian masses/cysts and ovarian al. (2009) found that the algorithm correctly analyzer, Elecsys 2010 analyzer: 2.7 – 4.3 %
cancer classified 94 % of women with epithelial cobas e 601/e 602 modules, E170: 2.6 – 3.4 %
In the early stages of ovarian cancer, symp- • The combination of HE4 and CA 125 ovarian c ancer.1 This high accuracy in • Repeatability cobas e 411 analyzer,
toms are unspecific and cause little, if any, shows the greatest accuracy in differen stratifying women with low or high risk for Elecsys 2010 analyzer: 1.3 – 1.8 %
discomfort. Therefore, new methods and tiating between patients with EOC vs. EOC contributes to better diagnosis, treat- cobas e 601/e 602 modules, E170: 1.5 – 1.9 %
biomarkers which can help in diagnosing those with benign pelvic masses ment and outcome.
this disease at an earlier stage are highly
desirable. The biomarker HE4 (human epi- Improved monitoring of ovarian cancer
Pelvic mass: Risk of Ovarian Malignancy Algorithm (ROMA)
didymal protein 4) together with the marker recurrence and progression
CA125 can play a very important role here. HE4 correlates with the recurrence status in
Pre-menopausal Post-menopausal
women with a diagnosis of EOC and is an
earlier marker for recurrence than CA 125.
PI = -12.0 + 2.38*LN[HE4] + 0.0626*LN[CA125] PI = -8.09 + 1.04*LN[HE4] + 0.732*LN[CA125]
PI = predictive index
Reliable results with efficiency
ROMA-value [%] = exp(PI) / [1 + exp(PI)] * 100
• Excellent precision and lot-to-lot
(exp(PI) = ePI)
consistency
• Comprehensive tumor marker menu <11.4% ≥11.4 % < 29.9 % ≥ 29.9 %
available on all cobas® platforms low risk high risk low risk high risk
Calculation of the ROMA-values for pre-and postmenopausal women and individual cut-points for the Elecsys assays
to separate between low and high risk patients.
1M
oore, R.G. et al. (2009). A novel multiple marker bioassay utilizing HE4
and CA125 for the prediction of ovarian cancer in patients with a pelvic
mass. Gynecologic Oncology, 112, 40-46.
80 | 81
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Elecsys® ProGRP
www.cobas.com
Crucial information for differential d iagnosis
in lung cancer and monitoring of small-cell lung
cancer patients
Progastrin-releasing peptide (ProGRP) In future, lung cancer biomarkers such as • Lung cancer biomarkers available on a
is a tumor marker with benefits for the ProGRP can also play an important role in single automated platform – CEA, CYFRA
management of small-cell lung cancer assessing therapy resistance of patients 21-1, NSE, ProGRP and SCC
patients. receiving targeted EGFR-tyrosine kinase • Equivalent performance between plasma
inhibitor (TKI) therapies. It has been de and serum for flexibility and convenience,
Lung cancer is one of the most common monstrated that a subset of NSCLCs with thus offering advantages over existing
cancers in the world with 1.35 million new mutated EGFR return as SCLC when resis- assays2
cases diagnosed every year. The two main tance to EGFR-TKIs develops and that this
histological types of the disease are small is caused by a transformation from NSCLC Product characteristics
cell lung cancer (SCLC) and non-small cell to SCLC.1 • Assay time: 18 min.
lung cancer (NSCLC). It is important to • Sample material: • Sample volume: 30 μL
distinguish between these two subtypes Your benefit – Serum collected using standard • Limit of detection (LoD): 3 pg/mL
as they have different treatments and prog- • High sensitivity and discrimination aiding s ampling tubes or tubes containing • Measuring range (lower end defined
noses. NSCLC (approx. 80 % of cases), the accurate differential diagnosis of SCLC separating gel by LoD): 3 – 5,000 pg/mL
when in the early stages, is curable with • Excellent precision across the entire – Li-heparin plasma, K2-EDTA and
surgery. SCLC, however, is an aggressively measuring range for reliable results K3-EDTA plasma
spreading neoplasm of rapid growth that
is usually only treatable with chemo and N=105 N=748 N=37 N=169
radiotherapy. Lung cancer 120,000
SCLC
differential
>80.1 pg/mL 20,000
diagnosis
ProGRP (pg/mL)
ProGRP is the tumor marker of choice for 5,000
SCLC as it aids in quick and decisive ProGRP 1,000
NSCLC
discrimination between SCLC and NSCLC serum/plasma 200
<80.1 pg/mL 100
for faster decisions on patient treatment. level 50
20
ProGRP is also a tumor marker that can be The 80.1 pg/mL cut-off value is based on the 95 % 10
used to assess response to therapy as well s pecificity of the NSCLC collective. 3
NSCLC NSCLC SCLC SCLC
as to monitor recurrence of the disease. China EU China EU
1 O ser, M.G. et al. (2015). Transformation from non-small cell lung cancer to small-cell lung cancer: Use of ProGRP for the primary differential diagnosis in lung cancer. The ability of ProGRP to distinguish
molecular drivers and cells of origin. Lancet Oncol.; 16: e165-172. SCLC from NSCLC was investigated in a study on 1059 patients in 5 centers in Europe and China
2K orse, C. et al (2015). Multicenter evaluation of a new progastrin-releasing peptide (ProGRP) (206 SCLCs and 853 NSCLCs), and ProGRP levels were correlated with biopsy proven histology.
immunoassay across Europe and China. Clinica Chimica Acta 438, 388-395. (Source: Elecsys ProGRP Method Sheet)
82 | 83
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Elecsys ® SCC
NEW
An important part of Roche’s portfolio

in tumor markers for managing patients
with squamous cell cancers
The SCC assay is used as an aid in types of lung cancer. Based on literature,
the management of patients with squamous SCCA elevated serum levels were
cell carcinoma in conjunction with found to be indicative of NSCLC if renal
other methods that align to the standard failure and dermatological diseases
clinical management guidelines. were excluded. Utility of SCCA in lung
cancer has been also reported to
SCC antigen (SCCA) has been studied in its indicate disease recurrence and residual
involvement in squamous cell malignancies disease following treatment and
including lung, uterine cervix, esophagus, response to therapy.
head & neck, anal canal and skin for many • The most common histology in cervical
years. SCCA levels can be elevated in cancer is SCC, with SCCA being the
squamous cell cancers and it has been biomarker of choice for this histology.
reported that more advanced cancer stages Serum levels of SCCA have been found
are associated with higher SCCA levels to correlate with tumor stage, tumor size
e specially in lung and cervical cancer. It and residual tumor after treatment,
was reported that measurement of the recurrent or progressive disease, and Your benefit Product characteristics
antigen, in serial determinations, aids in survival in patients with squamous • Combining SCC antigen with other lung • Assay time: 18 min.
the assessment of disease recurrence, cell cervical c ancer. cancer biomarkers (ProGRP, CYFRA 21-1, • Sample material: Serum, plasma
residual disease following treatment, and • 90 % of head & neck cancers are NSE and CEA) gives a clearer picture on • Sample volume: 15 μL
response to therapy. SCCs, in patients with primary tumors, the patient’s status • Measuring range: 0.1– 70 ng/mL
SCCA s erum levels were related to • SCC antigen as biomarker for cervical • LoQ: 0.24 ng/mL
SCC antigen in different types of nodal involvement with significantly higher cancer is another tool in patient • Precision: < 5 %
squamous cell cancers: levels in node-positive patients. Multi management together with other markers • Detection of SCC antigen 1 and 2
• SCCA has been reported as a biomarker variate analyses showed that SCCA is a for gynecological malignancies (i.e. CA • Standardization: Abbott Architect
for non-small cell lung cancer significant independent predictor of 125, HE4, CA 15-3, HPV, CINtec plus)
(NSCLC), mainly of the squamous d isease-free survival and pretreatment • High assay precision for accurate and
cell carcinoma type. SCC in lung levels are an independent prognostic sustainable results for patient monitoring
is closely correlated with a history of indicator in patients with head and neck • One blood sample for all lung cancer
tobacco smoking, more than other malignancies. biomarkers for time and cost efficiency
• High reagent on-board stability
• Short turn around time for fast results
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Elecsys® Calcitonin
www.cobas.com
A powerful tool for the diagnosis and monitoring
of medullary thyroid carcinoma (MTC)
Thyroid carcinoma is the most common Your benefit Product characteristics

malignancy of the endocrine system. In up A marker with high specificity • Assay time: 18 min.
to 10 % of all thyroid carcinoma patients a for MTC (Figure 1) • Sample material: Serum, Li-heparin
medullary thyroid carcinoma (MTC) is iden- • Sensitive tool for diagnosis and follow- plasma, K2-EDTA plasma, K3-EDTA plasma
tified. These carcinoma produce elevated up of MTC • Sample volume: 50 μL
serum concentrations of calcitonin and • High correlation with tumor burden, • LoB, LoD, LoQ*: 0.3 pg/mL, 0.5 pg/mL,
therefore can be diagnosed with an excep- supporting early detection of new or 1 pg/mL
tional degree of accuracy and specificity by residual disease • Measuring range: 0.5 – 2,000 pg/mL
immunoassays measuring serum calcitonin. • Traceability: IRP WHO 89/620
The diagnostic marker calcitonin is a sen Elecsys® Calcitonin with high precision • Total imprecision:
sitive and specific tumor marker for the • High sensitivity and precision at low – cobas e 411 analyzer, E2010: 2.6 – 5.2 % * LoB = Limit of Blank; LoD = Limit of Detection;
diagnosis as well as for the life-long moni- end concentrations ensure improved – cobas e 601/e 602 modules, E170: LoQ = Limit of Quantitation with a total allowable
error of ≤30 %
toring of MTC patients after thyroid surgery. follow-up and monitoring (figure 2) 1.6 – 2.3 %
• Excellent precision across the entire
Elecsys® Calcitonin – excellent precision measuring range support accurate results Elecsys® Calcitonin – high specificity for MTC
at low concentrations Cut-off Grey zone
Workflow efficiency with the most 1,000,000
MODULAR 2%
complete automated thyroid portfolio
Elecsys® Calcitonin (pg/mL)

ANALYTICS max. CV at 4.2 pg/mL 100,000
EVO < E 170 >, • All tests required for differential diagnosis
cobas e 601 /
e 602 module of thyroid diseases are consolidated on 10,000
Immulite® 1000/ 11.4 %

one platform, including routine thyroid 1,000
2000/2500 max. CV at 22.0 pg/mL assays and specialties such as Elecsys
Liaison® 13 % TgII, Elecsys Calcitonin, Elecsys Anti-Tg, 100
CT II-Gen max CV at 4.4 pg/mL Elecsys Anti-TPO and Elecsys Anti-TSHR 10
0 5 10 15
Interassay CV (%)
0
MTC MTC Apparently Apparently Thyroid Thyroid NET Malignant Graves’ Hashimoto’s
(medullary recurrence healthy healthy nodules nodules (neuro- diseases disease disease
Figure 2: Comparison of interassay CVs (coefficient of thyroid (n = 18) females males females males endocrine other (n = 88) (n = 138)
carcinoma) (n = 193) (n = 162) (n = 147) (n = 47) tumours) than MTC
variation) at the lowest concentrations tested. Source: (n = 15) (n = 5) (n = 14)
package inserts; March 2013.
Figure 1: Calcitonin is a highly specific marker for MTC, allowing early and specific diagnosis and reliable monitoring.
Source: Performance Evaluation Study 2013, data available upon request.
86 | 87
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Elecsys® Tg II
The power to offer more for differentiated
thyroid cancer (DTC) management
The main application for Thyroglobulin (Tg) Your benefit High quality patient results and
testing is the post‑operative follow‑up of Excellent functional sensitivity accurate long-term monitoring
patients with differentiated thyroid carcinoma and precision • Excellent precision across the entire
(DTC). Detectable levels of serum Tg after • Improved sensitivity comes with better measuring range supports accurate
total thyroidectomy are indicative of persis- precision in the range around the clinical results
tent or recurrent DTC. cut-off and improved negative predictive • Lot-to-lot consistency across all cobas®
value platforms allows a reliable long-term
• Sensitive Tg assays can avoid TSH- patient monitoring
stimulated Tg testing during follow-up • Elecsys Tg II shows lower TgAb interfer-
in low-risk patients ence compared to other assays
• Patients with a basal Tg below the
functional sensitivity of a sensitive Tg Higher sensitivity allows for potentially Product characteristics
assay have a high chance of being free earlier detection of persistence or • Assay time: 18 min.
of disease recurrence • Sample material: Serum, K2-EDTA plasma,
• Increasing concentrations of Tg (even K3-EDTA plasma
at low concentrations) are an early and • Sample volume: 35 μL
Analytical sensitivity/LoD Functional sensitivity
reliable indicator of recurrent disease • LoB, LoD, LoQ*: 0.02 ng/mL, 0.04 ng/mL,
2nd gen. 0.05–0.1 ng/mL 1st gen. 0.5–1 ng/mL
• Treatment is usually more successful 0.1 ng/mL
Roche (Elecsys Tg II) 0.04 0.09
with early detection as the tumor burden • Measuring range: 0.04 – 500 ng/mL
Siemens (Immulite®) 0.2 0.9
is lower • Traceability: BCR-CRM 457
Danaher (Access) 0.1
• Total imprecision:
DiaSorin (LIAISON®) 0.2
– cobas e 411 analyzer, E2010: 2.6 – 9.2 %
BRAHMS (Kryptor) 0.17 0.5
– cobas e 601/e 602 modules: 4.0 – 5.9 %
BRAHMS (K. compact plus) 0.09 0.15
0.01 0.1 1
Tg concentration (ng/mL)
Sensitivity of current automated Tg assays: Elecsys Tg II with best-in-class sensitivity.

Source: Package inserts, Feb. 2013.
* LoB = Limit of Blank; LoD = Limit of Detection;

LoQ = Limit of Quantitation with a total allowable
error of ≤20 %.
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Elecsys® Anti-TSHR
www.cobas.com
Complex testing simplified and automated
Elecsys Anti-TSHR (TRAK) is a fully auto- Your benefit Product characteristics

mated test for detection of autoantibodies Improved efficiency • Assay time: 27 min.
to the TSH receptor. • Fully automated test for more workflow • Sample volume: 50 µL
efficiency, allows for consolidation of tests • Measuring range: 0.3 – 40 IU/L
Clinical utility: required for differential diagnosis of • Functional sensitivity: 0.9 IU/L
• Detection or exclusion of Graves’ auto- thyroid diseases • Cut-off: 1.75 IU/L
immune hyperthyroidism and differentia- • Rapid availability of Anti-TSHR results • Precision: < 6 %
tion from disseminated autonomy of the supports cost- and time-efficient differen- • Strong discrimination between positive
thyroid gland (figure 1) tial diagnosis of thyroid diseases and and negative results
• Monitoring therapy and prediction early treatment • Standardization: NIBSC 1st IS 90/672
of relapse
• Assessing the risk of developing fetal High quality results High clinical accuracy of Elecsys® The clinical study comprised:
hyperthyroidism in the last trimester of • Advanced assay quality based on proven Anti-TSHR • 436 samples from apparently healthy
pregnancy and leading ECL technology 1 individuals
• Excellent precision across the entire 0.9 • 210 patients with thyroid diseases
measuring range (figure 2) 0.8 excluding Grave's disease
• High diagnostic value based on high 0.7 • 102 patients with untreated Grave’s disease
sensitivity paired with high specificity 0.6
Sensitivity
Area under curve (AUC): Using a cutoff of 1.75 IU/L a clinical
0.5
0.98 (95 % CI: 0.97– 0.99)
35 0.4 sensitivity of 97 % and a specificity of 99 %
30 0.3 was obtained.
25 0.2
FS (CV 20 %): 0.73 IU/L
CV [%]
20 0.1
15 0
Cut-off limit 1.75 IU/L: CV 11 % 0 0.2 0.4 0.6 0.8 1
10 Hermsen, D. et al. (2009). Technical evaluation of the
Specificity
5 first fully automated assay for the detection of TSH
0 Figure 1: Clinical accuracy of Elecsys Anti-TSHR. receptor autoantibodies. Clin Chim Acta, 84 – 8 9.
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
TRAb, mean values [IU/L]
Figure 2: The functional sensitivity of Elecsys Anti-TSHR at approx. 0.9 IU/L is significantly below the cut-off
(≥1.75 IU/L), allowing clear differentiation of pathological results.
90 | 91
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Elecsys® Vitamin D total

www.cobas.com
Allowing better patient care with results
you can trust
Vitamin D has a proven impact on bone Your benefit Product characteristics Proven accuracy with certified Vitamin D
mineral density and bone quality. Desirable • Standardized against LC-MS/MS (traceable • Assay time: 27 min. Reference Panel
levels of 30 ng/mL have been shown to to NIST) for confidence in patient results • Sample material: Serum and plasma 80 %
(Elecsys-Ref value) / Ref value

reduce the risk of falls and fractures. • High lot-to-lot consistency for optimal • Sample volume: 15 μL 60 %
Normalized difference
therapy monitoring • Functional sensitivity: 4.01 ng/mL 40 %
There is also growing scientific evidence • Excellent functional sensitivity and superior (10.0 nmol/L) (CV 18.5 %) 20 %
linking the level of vitamin D (25-OH) to an precision over the clinically relevant range • Repeatability: Within-run precision: 0% 3.9 %
increased risk of other indications such as • Efficiency due to consolidation of Vitamin D <15 ng/mL: SD ≤ 1 ng/mL, -20 %
diabetes, cardiovascular disease, autoimmune total, b-CrossLaps, P1NP, Osteocalcin and >15 ng/mL: ≤ 6.5 % -40 %
diseases, and different forms of cancer. PTH testing on one fully automated platform • Reproducibility: Intermediate precision: -60 %
The Elecsys Vitamin D total assay aids in <15 ng/mL: SD ≤1.7 ng/mL, -80 %
0 50 100 150
the assessment of vitamin D sufficiency. >15 ng/mL: ≤11.5 % 25-OHD (nmol/L)
Traceability and standardization
Assessment of Vitamin D Reference Panel, certified by
National Institute of Standards & Technology (NIST) University of Ghent LC-MS/MS reference measurement
Standard reference material (SRM) 2972 procedure.
Ethanolic solutions of vitamin D2 (25-OH) and vitamin
D3 (25-OH)
Consistent results from lot to lot
SRM 972
80
Four levels of serum with different concentrations of
vitamin D (25-OH), value assignment by LC-MS/MS 70
64.2
60
25-OHD (nmol/L)
50
LC-MS/MS
40
Liquid chromatography tandem mass spectrometry
NIST SRM2972 used for calibration, NIST SRM972 30
for quality control 20 20.9
10
0
Elecsys Vitamin D total 23.5.12 12.7.12 31.8.12 20.10.12 9.12.12 28.1.13 19.3.13 8.5.13 27.6.13
Fully automated protein binding assay Date
calibrators based on serum matrix, standardization
against LC-MS/MS Long-term recovery of serum pools over 4 different reagent lots.
Wielders et al. (2014). J Clin Lab Anal, Epub ahead of print DOI 10.1002/jcla.21793.
92 | 93
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Elecsys® Anti-Mullerian Hormone (AMH)

www.cobas.com
Providing clinical confidence in the assessment
of ovarian reserve
Mean female age at first birth has in- Your benefit Precision and sensitivity
creased steadily over the past few decades • Fully automated, fast, sensitive and robust Elecsys® AMH Manual method
in many developed countries. This post- measurement of AMH 100
ponement leads to couples attempting to • High precision over entire measuring 80
CV %
60
have children during a period where female range for reliable results
40
fertility is already in decline. 30 % of infer- • Clinical agreement with Antral-Follicle- 20
tility problems among women arise from Count (AFC) 0
0.23 ng/mL 0.79 ng/mL 0.96 ng/mL 2.73 ng/mL 4.92 ng/mL 13.6 ng/mL 17.96 ng/mL
diminished ovarian reserve. • Age specific reference ranges and PCOS HSP 1 HSP 2 PC AMH 1 HSP 3 PC AMH 2 HSP 4 HSP 5
(polycystic ovary syndrome) information Concentration
Anti-Mullerian hormone (AMH) is a Figure 1: Precision comparison between Elecsys and a manual method on the market as part of a method comparison
direct serum marker of functional ovarian Product characteristics study conducted. The study has been run according to CLSI Protocol (CLSI-EP5).
reserve and plays an important role in • Assay time: 18 min. HSP – Human Serum Pool, PC AMH – PreciControl AMH
assessing ovarian reserve levels and • Traceability: Standardized against BCI

therefore the capacity to provide eggs AMH Gen II ELISA (unmodified) Agreement and low variability in results vs. AFC
for fertilization. • Sample material: Serum and Li-heparin AMH (ng/mL) AFC
plasma N=37 N=55 N=59 N=111 N=57 N=115 N=17

45 15
40
AMH assists in assessment of ovarian • Sample volume: 50 μL
AMH (ng/mL)
35
30 10
reserve, for example identifying in patients • LoB, LoD, LoQ*: 0.007 ng/mL, 25
AFC
20
at risk of having diminished ovarian reserve. (0.05 pmol/L), 0.010 ng/mL, 15 5
10
AMH can also add prognostic information (0.071 pmol/L), 0.030 ng/mL, 5
0 0
to the counseling and planning process for (0.214 pmol/L) Site 1 Site 2 Site 3 Site 4 Site 5 Site 6 Site 7
infertile couples seeking treatment. • Measuring range: 0.01 – 23 ng/mL Figure 2: Distribution of AFC and AMH in 7 site multicenter evaluation. Multiple technicians performed AFC
(0.071 – 164.2 pmol/L) at each site.
There is also growing scientific evidence • Intermediate imprecision:
linking between the level of AMH and Poly- – cobas e 411 analyzer: 2.9 – 4.4 %
cystic ovary syndrome (PCOS), prediction – cobas e 601/e 602 modules: 2.7 – 3.5 %
of time to menopause, disorders of sex de- – Lowest conc. measured: 0.232 ng/mL
velopment in children, and ovarian function
in cancer patients under chemotherapy.
* LoB = Limit of Blank, LoD = Limit of Detection, LoQ = Limit of Quantitation
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Elecsys® sFlt-1/PlGF
www.cobas.com
Short term prediction and diagnosis
of preeclampsia
Preeclampsia is a serious multi-system Your benefit Product characteristics

complication of pregnancy, occurring in • Elecsys sFlt-1 and PlGF immunoassays Technical assay features on Elecsys® sFlt-1 and PIGF
3 – 5 % of pregnancies, and it is one of the for preeclampsia are the first available sFlt-1 PlGF
leading causes of maternal and perinatal and approved automated diagnostic Assay time 18 min.
morbidity and mortality worldwide. tests for fast and easy assessment in a Sample material Serum
clinical context Sample volume 20 μL 50 μL
Preeclampsia is defined as new-onset of • The measurement of the Elecsys sFlt-1/ Measuring range 10– 85,000 pg/mL 3 – 10,000 pg/mL
hypertension and proteinuria after 20 weeks PlGF ratio is a reliable tool to identify the
of gestation. The clinical presentation of patients that are at high risk to develop The Elecsys sFlt-1/PlGF ratio can improve the management of suspected preeclampsia
preeclampsia and subsequent clinical course preeclampsia requiring a closer monitoring patients allowing short-term prediction and diagnosis. An improved prediction and diagnosis
of the disease can vary tremendously, making and to confidently send home patients that of preeclampsia can allow a reduction of inappropriate discharges as well as a reduction
prediction, diagnosis and assessment of are not going to develop the disease of unnecessary hospitalizations, therefore a reduction of the health care burden.
disease progression difficult. • Early and precise diagnosis of pre-
eclampsia leads to effective clinical Early onset preeclampsia – Late onset preeclampsia –
gestational week 20 – 34 gestational week 34 to end of pregnancy
Angiogenic factors (sFlt-1 and PlGF) are management and improves the outcome
sFIt-1/ Diagnosis 99.4 % specificity sFIt-1/ Diagnosis 95.5 % specificity
proven to play an important role in the for both mother and child PIGF the patient has PIGF the patient has
pathogenesis of preeclampsia and their ≥ 85 preeclampsia ≥ 110 preeclampsia
concentrations in maternal serum are Sensitivity: 88.0 % Sensitivity: 58.2 %
sFIt-1/ Prediction 38.6 % PPV sFIt-1/ Prediction 38.6 % PPV
altered even before the onset of the disease
PIGF rule-in the patient is at PIGF rule-in the patient is at
making them a tool for prediction and < 85 in the next high risk to develop < 110 in the next high risk to develop
≥ 38 4 weeks preeclampsia within ≥ 38 4 weeks preeclampsia within
diagnosis of preeclampsia. the next 4 weeks
the next 4 weeks
sFIt-1/ Prediction 99.1 % NPV sFIt-1/ Prediction 99.1 % NPV
PIGF rule-out the patient will PIGF rule-out the patient will
< 38 for the next not develop < 38 for the next not develop
1 week preeclampsia in 1 week preeclampsia in
the next 1 week the next 1 week
Verlohren, S., Herraiz, I., Lapaire, O., Schlembach, D., Moertl, et al. (2012). Am J Obstet Gynecol. 206(1),58.e1– 8.
Verlohren, S., Herraiz, I., Lapaire, O., Schlembach, D., Zeisler, H., et al. (2014). Hypertension. 63(2),346–352.
Schnettler, W.T., Dukhovny, D., Wenger, J., Salahuddin, S., Ralston, S.J., Rana S. (2013). BJOG 120(10),1224–123.
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Tina-quant® Hemoglobin A1c

www.cobas.com
Efficiency for the diagnosis and monitoring
of diabetes
HbA1c is viewed as a significant and Your benefit Product characteristics

accepted diabetic marker. For most people One test for diagnosis and monitoring • Twin test reaction technology
with diabetes, the target HbA1c is below • First HbA1c assay on the market that can • Reagent lot-specific calibration
48 mmol/mol (6.5 % HbA1c), since evidence be used for the diagnosis of diabetes and • NGSP certified and traceable to the IFCC
shows that this can reduce the risk of to identify persons at risk of developing and DCCT reference method
developing diabetic complications. diabetes, and for monitoring (FDA/CE) • Dual reporting in mmol/mol and %
• Intermediate precision (CV) <1.5 %
In 2009 an international expert committee Reliable diabetes management • Whole blood and hemolysate application
recommended HbA1c as a test for the diag- • With excellent precision and accuracy • 70 % immersion depth into the primary
nosis of type 2 diabetes and prediabetes. tube for correct and reproducible recovery
The Tina-quant assay provides a fast and Uncompromised performance of fast settling whole blood samples
precise routine HbA1c measurement for • With no interference from HbAS, • FDA approved/CE
the comprehensive care of your diabetes HbAD, HbAD and HbAE or acetylated,
patient. carbamylated Hb and labile HbA1c
Glucose Val His Leu Thr Pro Glu

Efficiency, cost and workflow
improvements
• Easy integration into routine testing for Epitope of Roche antibody
efficiency, cost and workflow improve-

Glycated (HbA1c) N-terminal hexapeptide and
ments. Without post-analytical data epitope recognition of the Roche HbA1c antibody for
review (e.g. interpretation of chromato- measuring the “true” HbA1c as defined by the IFCC
grams) reference system.
98 | 99
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The full SWA immunosuppressive

NEW
drug assay panel www.cobas.com
Trusted and consistent results for

organ transplant patients
Optimal immunosuppressive therapy, Your benefit Consistent results for life-long

defined clinically and by therapeutic drug Consolidation for optimized workflow monitoring
monitoring (TDM), is essential to prevent The new Elecsys Sirolimus and Everolimus • Excellent lot-to-lot comparability and
acute rejection and ensure long-term survival assay complete the ISD menu and are an traceability
of both the patient and the allograft. Char- important addition to the cobas TDM • Consistent patient results across all
acterized by a narrow therapeutic window, menu making it the most complete ISD c obas® platforms due to universal
the use of immunosuppressive drugs product offering. reagent concept
(ISDs) requires both precise and consistent • The full ISD menu now available on one • Low variability across different customer
measurement of their concentration in automated and integrated Roche SWA labs proven in external quality schemes
whole blood during life-long monitoring. platform: • High comparability to well established
– Best-in-class automated MPA available and validated LC-MS/MS
on cobas c modules
– Elecsys Cyclosporine and Tacolimus
N = 1029 samples, Weighted Deming Regression now completed with Sirolimus and Product characteristics
y = 1,07 x – 0,269, r = 0,97 Everolimus on cobas e modules Tacrolimus Cyclosporine Sirolimus Everolimus
Kidney Liver Heart Unknown • One universal pre-treatment procedure Assay time 18 min.
40 for all ISD assays increase efficiency, en- Sample material EDTA whole blood
sure high quality results for every product Sample volume 300 µL
30 and reduce handling errors in the lab Sample pretreatment Identical sample pretreatment
cobas (ng/mL)
• Outstanding possibilities for consolidation Sensitivity LoB * 0.3 ng/ml 20 ng/mL 0.4 ng/mL 0.4 ng/mL
20 with >230 parameters on one cobas® LoD * 0.5 ng/mL 30 ng/mL 0.5 ng/mL 0.5 ng/mL
LoQ * 1.0 ng/mL 50 ng/mL 1.5 ng/mL 1.0 ng/mL
platform
Measuring range 0.5 – 40 ng/mL 30 – 2,000 ng/mL 0.5 – 30 ng/mL 0.5 – 30 ng/mL
10
Total imprecision
High precision for confidence cobas e 411 analyzer 2.1–14.2 % 4.2 – 9.2 % 2.8 – 10.9 % 2.7 – 8.1 %
0 in results cobas e 601/e 602 modules 2.4 –10.4 % 3.1– 6.4 % 3.4 – 9.5 % 3.9 – 6.7 %
0 10 20 30 40
LC-MS/MS (ng/mL)
• High precision at low drug concentrations * L
oB = Limit of Blank; LoD = Limit of Detection; LoQ = Limit of Quantitation
Elecsys® Tacrolimus: excellent correlation with a well

and across a wide measuring range
evaluated LC-MS/MS. (Source: Multicenter evaluation • Superior performance confirmed in
study 2013) routine customer laboratories
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Hemostasis testing
Platelet function testing Roche is moving towards a comprehensive

new hemostasis testing portfolio with a
The cobas t 411 coagulation analyzer is
the recent addition to Roche’s Hemostasis
Hemostasis
number of industry firsts and innovative portfolio. It serves low- to medium-volume
applications for early disease detection central coagulation laboratories. Featuring
and monitoring. From easy-to-use, low- innovative sample and reagent management
Coagulation volume analyzers for self- and professional

monitoring, to systems meeting the high
concepts, It enables increased operator
convenience and productivity.
Laboratories efficiency requirements of the laboratory,

Roche’s products provide the highest quality The coagulation portfolio will be expanded
Multiplate
results, offering outstanding productivity by instruments that will serve the medium-
while reducing complexity. to high-volume laboratories and for which
connectivity to Roche’s automation line will
Like Roche’s current instruments, the new be available.
generation of testing solutions is driven by
a commitment to deliver high-quality, cost- The new coagulation analyzers, combined
effective solutions capable of addressing with the point-of-care meters, the
the current and future testing needs of a Multiplate® analyzer and the LightCycler®
wide range of customers. for genetic hemostasis testing will allow
Roche to provide a full portfolio of solutions
for primary and secondary hemostasis
testing.
For more information please

visit www.cobas.com and
www.roche-multiplate.com
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cobas t 411 coagulation analyzer

NEW
www.cobas.com
For maximum efficiency
The cobas t 411 coagulation analyzer is Your benefit Premium safety

the powerful first member of the new Ease-of-use • Automated multi-vendor cap-piercing
coagulation family of products designed for • High reagent, sample and cuvette storage • Positive sample management via the
the low to medium throughput laboratory. capacity requires minimal interaction integrated automatic barcode scanner
during daily use • Patient results are fully traceable
The cobas t 411 analyzer is ideally suited for • Start mechanism via one button start
maximum efficiency and flexibility supported system Product characteristics
by innovative features like automated, multi- Throughput
vendor cap-piercing and integrated barcode Dynamic workflow • Up to 140 tests/hour (PT)
scanning for samples and reagents. • Continuous loading • Up to 100 tests/hour (mixed mode)
• Large onboard storage capacity, walk-
Featuring continuous loading of reagents, away time is maximized and hands-on Samples
samples and cuvettes, the cobas t 411 time minimized • Up to 100 samples on-board
analyzer ensures maximum productivity • Dedicated STAT port • Cap-piercing
and dynamic workflow. • Dedicated STAT port
• Continuous loading via 5 position racks
Reagents
• Continuous rack-based loading
• Up to 70 vials on-board capacity
• Extended Routine Menu inlcuding PT,
APTT, FIB, TT, AT and DD
Test principle Software

• Unique opto-mechanical measuring • Comprehensive QC program including
principle Levey-Jennings
• Clotting, chromogenic, immuno- • User-definable protocols
turbidimetric assays • LIS connectivity
cobas t 411 coagulation analyzer
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Multiplate® analyzer
www.roche-multiplate.com
Platelet function testing with best-in-class
predictivity
Blood platelets play a pivotal role in physi- have a 5 – 10 fold increased risk of stent Your benefit Consistent results
ological hemostasis, but also in the devel- thrombosis, stroke and myocardial infarc- Cost-effective therapies • using standardized reagents and
opment of arterial thrombosis (myocardial tion1-4 following percutaneous coronary • in cardiac surgery10 procedures
infarction and stroke). Platelet function interventions. Multiplate delivers best-in- • in coronary interventions11
testing is utilized in the analysis of inherited class predictivity5 and evidence is available Medical momentum
and acquired platelet function disorders demonstrating that Multiplate guided anti- Fast and easy assessment • More than 400 Medline publications,
that may cause a transient or permanent platelet therapy has the potential to improve • of platelet function from small volumes consensus papers with Multiplate and
bleeding tendency. The Multiplate analyzer patient outcome.6-8 of whole blood published guidelines for PFT
can detect platelet dysfunction and thus
aid in the therapeutic management of such The Multiplate analyzer also plays a role in Best predictivity Product characteristics
patients. the analysis of platelet function in anesthesia • for stratification of bleeding risk in • High throughput: 30 tests/hour
and intensive care, where platelet dysfunc- surgical procedures • Sample volume: only 300 μL per analysis
It can also be used for monitoring of anti- tion can lead to severe bleeding complica- • for tailored anti-platelet therapy • Fast turn-around time: 10 min./test
platelet drugs where both compliance and tions. The detection or exclusion of platelet
drug effectiveness are key issues. It was dysfunction before invasive procedures Comprehensive reagent menu of CE marked tests and controls
shown with Multiplate results1 that up to or in bleeding patients can aid the risk
Products Description
20 % of patients do not respond adequately stratification and management in these
ADPtest ADP induced platelet activation sensitive to clopidogrel, prasugrel and other ADP
to clopidogrel treatment. These patients situations.9-10 receptor antagonists
ASPItest Cyclooxygenase dependent aggregation (using arachidonic acid) sensitive to
1 Sibbing, D. et al. (2009). J Am Coll Cardiol. Mar 10; Aspirin®, NSAIDs and other inhibitors of platelet cyclooxygenase
53(10):849-56. COLtest Collagen induced aggregation
2 Sibbing, D. et al. (2010). Thromb Haemost. Jan;
103(1):151-9. RISTOtest vWF and GpIb dependent aggregation (using ristocetin)
3 Schulz, S. et al. (2010). Am Heart J. Aug; 160(2):355-61. TRAPtest Platelet stimulation via the thrombin receptor (using TRAP-6), sensitive to IIbIIIa
4 Siller-Matula, J.M. et al. (2010). J Thromb Haemost. Feb; receptor antagonists
8(2):351-9. Prostaglandin E1 reagent For the assessment of ADPtest HS (high sensitivity). For the assessment of positive
5 Bonello, L. et al. (2010). J Am Coll Cardiol. Sep 14; (i.e. abnormal) controls of the ADPtest
56(12):919-33. ASA reagent Inhibitor of cyclooxygenase. Addition of ASA reagent to the blood sample leads to
6 Siller-Matula, J.M. et al. (2013). Int J Cardiol. Sep 1; 167(5): reduced aggregation responses in ASPItest and COLtest
2018-2023.
GpIIb/IIIa antagonist reagent Inhibitor of the platelet GpIIb/IIIa receptor. Addition to a blood sample leads to
7 Sibbing, D. et al. (2012). J Am Coll Cardiol. 59; E265. strongly reduced aggregation in the TRAPtest
8 Aradi et al. (2013). J Am Coll Cardiol. 61(10): E1922.
Hirudin blood tubes Anticoagulant for platelet function analysis with physiological calcium
9 Ranucci, M. et al. (2011). Ann Thorac Surg. Jan; 91(1):123-9.
concentrations
10 Weber, C.F. et al. (2012). Anesthesiology, Sep; 117(3):531-47.
11 Straub, N. et al. (2013). Thromb Haemost. Oct 24; 111(2). Liquid control set Quality control for electrical signal in impedance aggregometry based on the
analysis of an artificial liquid control material
[Epub ahead of print]
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Urinalysis
Combur Urinalysis has always been an important

diagnostic tool in medicine. Even today,
Today Roche offers a broad portfolio of
urinalysis solutions for different customer
Laboratories
urine is still a key health barometer for needs. Drawing on our 50 years of experi-
many diseases, mainly urinary tract infec- ence in urinalysis, starting with the launch
Sediment
tions, kidney disease and diabetes. The of the first Combur-Test ® strip, we have
analysis of urine can reveal serious diseases continuously improved strip technology for
that show no symptoms in their early stages clinical and general practice. In response
Urine work area solution but are treatable. These diseases can cause
severe damage if they remain undetected.
to customer needs for increased efficiency
and safety, we have developed a range
Point of Care Urine test strips are a crucial diagnostic

tool and easy to use, yielding quick and
reliable information on pathological changes
of analyzers with differing degrees of
automation and throughput capabilities.
By combining the proven Combur-Test strip
Physician’s office in the urine. Their diagnostic significance

lies primarily in first-line diagnosis, screening
technology with Roche automation, we
offer customized urinalysis solutions for
50 years experience during routine or preventive examinations,

and treatment monitoring.
physician office laboratories, hospital point-
of-care and central laboratory settings.

visit www.cobas.com
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Urinalysis from Roche Micral-Test ® strip for albumin in urine

Expertise coming from a long tradition Quick and secure results of albumin
of more than 50 years in urine
www.cobas.com
The Micral-Test is an easy to use test Fast and easy

designed to deliver quick and secure results, After 60 seconds, result is ready for visual
specific for human albumin and sensitive reading with a convenient color comparison
across the diagnostic range. Using one test on the strip box. The Micral-Test is easy to
for all patient groups, the Micral-Test is a handle and improves testing workflow.
cost efficient way to gain actionable health
Micral-Test ® Combur-Test ® cobas u pack Urisys 1100 ® information. Unique design of the Micral-Test strip
delivers secure results
Your benefit • The Immunological test principle with
Specific for human albumin monoclonal antibodies is highly specific
The Micral-Test is based on an immuno for human albumin
logical test principle using gold-labelled • The urine sample is absorbed by the test
monoclonal antibodies with a chromo- strip and transferred through the
genic color indicator ensuring confidence following two zones before reaching the
Sediment terminal cobas u 411 urine analyzer cobas ® 6500 urine analyzer series in results. detection pad:
Zone 1 – Conjugate Fleece contains free
Urine diagnostics portfolio Sensitive across the diagnostic range gold-labelled antibodies
The cutoff for positive results is 20 mg/L Zone 2 – Capture Matrix Fleece with fixed
Micral-Test ® Combur-Test ® Urisys 1100 ® cobas u 411 cobas 6500 urine
urine analyzer analyzer series with an excellent sensitivity of 97 %. The human serum albumin (HSA)
Automation Visual reading strip Visual reading and Instrument Semi-automated Fully automated Micral-Test does not show a “hook-effect”
grade for microalbumin for all UA platforms intended for single urinalysis system urine work area
measurements for small to solution for large-
because it uses a chromogenic color
in wards or in medium sized scale laboratories reaction instead of an agglutination reaction.
physicians’ offices laboratories
Workloads Manual Manual 10 – 50 samples 30 –100 samples 100 –1,000 samples
per day per day per day
Wick fleece Zone 1: Detection pad
Test strips Micral-Test Combur 2,3,4,5,6,7,9,10 Combur 10 Test UX Combur 10 Test M cobas u pack Conjugate
Test Combur 5 Test Matrix Fleece
Combur 7 Test
Consumables cobas u cuvette
Zone 2:
Capture
Sample level Matrix Fleece Carrier foil
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Combur-Test ® strip Urisys 1100 ® analyzer

Established quality – proven to perform Small and easy
Urine reagent strips are a useful tool for • Test area colors prevented from flowing The Urisys 1100 analyzer is a small semi- Your benefit
investigating, diagnosing and screening with an absorbent paper automated benchtop instrument for a Compact
diseases immediately. Reliable and precise • Reduction of the risk of false results workload of 10 to 50 samples per day. It is • Semi-automated urine analyzer for the
results are important, since adulterated through compensation of strong intrinsic optimal for small labs, doctor’s offices or small lab, ward or doctor’s office
results can lead to false negative results urine coloration with the availability of a in decentralized settings.
or re-testing of patients. Roche’s unique color compensation pad* Easy handling
test strip technology is used for visual test The high quality Combur-Test ® strips • Automatic printing of results
strips and for all instrument test strips. Easy strip handling provide accurate results in one minute
• Facilitation of analysis with a consistent which can be optionally printed out for Simplify your life
Your benefit reading time of 60 seconds for all your convenient documentation. • Eliminate manual documentation through
Accuracy parameters the export of data via host connection
• Combur-Test ® strip * detects even low • Advanced and hygienic strip handling
concentrations of glucose and erythro- with possibility of reading tip down Safety
cytes/hemoglobin (5 – 10 Ery/mL) in the • Prevent unauthorized access and comply
ERY/Hb
presence of vitamin C with accreditation requirements via an
COMP
UBG
GLU
PRO
LEU
KET
NIT
BIL
SG
pH
operator lock-out feature

Efficiency
• Avoidance of retesting and false-negative Product characteristics
results in glucose and blood even Diazonium • Workloads: 10 – 50 samples per day
salt Iodate
with high levels of ascorbic acid (up to Nylon impregnated impregnated • Throughput: approx. 50 test strips/hour
mesh mesh mesh
400 mg/L) with the application of an • Combur-Test ® is resistant to ascorbic
iodate impregnated mesh layer Plastic Absorbent
acid interference
carrier foil paper • Control-Test M for weekly calibration
Safety • Test strips *: Combur 10 Test ® UX
Combur-Test urine test strips from Roche have
• Independence interference from of iodate impregnated mesh layers and are uninfluenced
• Memory capacity: 100 results
glued components as a result of a unique by ascorbic acid. • Printer: Thermal printer
sealing technology * For instrument tests only. • Connectivity to the cobas POC IT solution
* Combur 7 Test ® , Combur5Test ® are not available in

all countries.
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cobas u 411 urine analyzer

www.cobas.com
Consolidated result management
The cobas u 411 semi-automated urine Your benefit Product characteristics

nalyzer is designed for workloads of
a Fast and efficient workflow • Workloads: 30 – 100 samples per day
approximately 30 –100 samples per day. • By connecting analyzer to sediment • Throughput: 600 tests/hour
terminal and consolidating the results • Continuous loading of test strips without
When connected to the optional barcode requiring a measurement cycle
reader and sediment terminal, this analyzer Ensure reliable results – optional barcode reader simplifies
designed optimized work and data flow. • Ascorbic acid does not interfere with manual work steps
test strips • Entry of tracking information including user
identification and lot n umbers for test
Safe and hygienic handling of strips strips, calibration strips and control material
• Due to netsealing technology
Consolidated analysis
Parallel working on the cobas u 411 analyzer
and its connected sediment terminal as a
result of a consolidated work and data flow
for strip analysis and microscopy. Easier
documentation and improved overview of
patient records with single print-out for
strip and microscopic information.
1. Sample ID input 5. Upload of microscopic results

Work list via LIS, barcode
scanner or manual input
4. Consolidated results 3. One workplace

Upload to LIS / Host or Microscopic examination
print out in one single record and input via keypad
2. Result download
Display of sample
ID + test strip
cobas u 411 urine analyzer Semi-automated urine work area solution.
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cobas ® 6500 urine analyzer series

www.cobas.com
One tube, one touch – fully automated
urine workflow
The cobas 6500 urine analyzer series is a Precise and safe strip results Product characteristics
fully automated urine work area solution for • High quality results by proven unique strip cobas u 601 urine analyzer
laboratories processing 100 – 1,000 urine construction based on 50 years experience • Fully automated urine strip new generation
samples per day. • Accurate, safe results by new technology • 12 on-board parameters
• Throughput: 240 samples/hour
Due to its modular design cobas 6500 Consolidation of urine work area • cobas u pack;
urine analyzer series can be installed as a • Convenient validation – – cassette with 400 test strips
stand-alone urine analyzer or as a stand- all results on one screen – Combur-Test ® strips cobas u 601 urine analyzer
alone microscopy analyzer or together as a • Full menu covers urine strip testing – two weeks on-board stability
fully automated urine work area. and urine sedimentation (humidity protected)
• New photometer technology for the strip
Your benefit Workflow optimization result reading
Automation of the gold standard • Full integration into lab automation • Detecting the intact and lysed erythrocytes
• Taking real microscopy images – elimi
nating operator variability and the need cobas u 701 microscopy analyzer
for manual review, improving TAT • Fully automated urine microscopy system cobas u 701 microscopy analyzer
• 11 on-board parameters
• Reagent-free system
• Throughput: 116 samples/hour
• 400 cuvettes in one package
(cobas u cuvette)
• Excellent counting performance
• Storage of real images
cobas 6500 urine analyzer series
cobas® connection module (CCM) connected to 2 cobas 8000, cobas p 501 post-analytical unit, cobas 6500
and cobas u 601
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Molecular diagnostics
Real-time PCR Roche is a pioneer in molecular diagnos-

tics. Since 1992 we have been providing
to identify the molecular characteristics
of patients and diseases, thus enabling
Virology
innovative tests based on the Nobel Personalized Healthcare.
Prize-winning polymerase chain reaction
(PCR) technology. Roche products also help to ensure the
Women’s health Thanks to our wide range of products,

safety of blood and blood products
by using Roche Molecular Diagnostics
Genomics/Oncology services and solutions we are able to cover

the needs of different types of hospitals
approved systems to screen donations.
Full automation
and laboratories worldwide. Besides molecular diagnostic solutions,
we also provide a range of innovative
Roche provides solutions for indication products for nucleic acid purification and
Blood screening areas such as hepatitis, HIV, transplantation,

women’s health, oncology, genomics and
PCR in the field of molecular biology.
Microbiology microbiology. We have recently expanded

molecular testing point of care segment to
better serve customers needs with after-
visit www.molecular.roche.com
Companion diagnostics hours and STAT testing within the primary

care segment. These solutions are designed
Molecular Point of Care to provide information that allows health-

care professionals to diagnose diseases
and monitor patients’ response to therapy.
In addition we offer a range of products
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Molecular diagnostics solutions

www.molecular.roche.com
Innovative, reliable and efficient
Laboratory needs
Meeting the requirements for confidence in Your benefit
• Medium throughput Manual or COBAS® AmpliPrep Instrument COBAS® TaqMan® 48 Analyzer
PCR results and comprehensive high- • Flexible, efficient workflow Manual low throughput
quality solutions, Roche offers a wide range • Innovative real-time PCR technology meets solution available with
COBAS® TaqMan® 48
of systems including full lab automation international guidelines for sensitivity and Analyzer
for unrivalled efficiency, integrated IVD and linear measurement range • Very low throughput cobas® Liat System
LDT processing for greater consolidation, • Confidence in results due to integrated On-demand testing for the
Point of Care
and connectivity to pre- and post-analytics. quality controls and physical and
biochemical contamination control

Blood and Donor Screening Systems
Workflow solutions for molecular diagnostics
• Very high throughput cobas® 6800/8800 Systems and cobas p 680 Instrument
• Absolute automation
Laboratory needs • Unmatched flexibility
IVD Systems
•V ery high throughput cobas® 8800 System
• Absolute automation • High throughput cobas s 201 System
• Unmatched flexibility
• Mid-high throughput cobas® 6800 System

• Absolute automation
• Unmatched flexibility LDT Solutions
• High throughput FLOW Solution
• Complete Workflow
• Mid to low throughput cobas® 4800 System

• Full automation
cobas z 480 Analyzer
available as standalone
solution with manual Roche Primary MagNA Roche PCR Roche PCR
sample prep for oncology Sample Handling Pure 96 Set-up Instrument
cobas x 480 Instrument cobas z 480 Analyzer
• Medium and low High Pure or MagNA Pure LC 2.0 Systems LightCycler ® 96 or 480 System
• Mid to low throughput COBAS AmpliPrep/COBAS TaqMan System
® ® ® throughput
• Full automation
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Test Overview
cobas® Liat System
cobas® Liat System

cobas x 480/z 480
cobas x 480/z 480

cobas® 6800/8800
cobas® 6800/8800
COBAS® TaqMan®
COBAS® TaqMan®
cobas® 4800,
cobas® 4800,
cobas s 201
cobas s 201
LightCycler ®
LightCycler ®
AMPLICOR
AMPLICOR
Detection
Detection
COBAS®
COBAS®
Viruses Sepsis pathogens
Cytomegalovirus Quant. • • Bacteria/Fungi Qual., Diff. •
Hepatitis B Quant. • • • Bacteria/Fungi Qual., Ident. •
Hepatitis C quant Quant. • • • Blood screening
Hepatitis C qual Qual. • MPX: HIV-1 **, HIV-2, HCV, HBV Qual., Diff. • •
Hepatitis C GT Genot. • * • • DPX: B19V/HAV Qual., Diff. • •
Herpes Qual., Diff. • • West Nile virus Qual. • •
Human Immunodeficiency Quant. • • • Hepatitis E Qual. •
Human Immunodeficiency Qual. • * • Bacteria
Human Immunodeficiency RUO Qual. • Strep A Qual. •
Human Papillomavirus Qual., Genot. • * • Oncology
Influenza A/B Qual., Diff. • BRAF Qual., Mut. Detect. •
Influenza A/B+RSV Qual., Diff. • BRAF/NRAS (LSR) Qual., Mut. Detect. • *
Parvo B 19 (RUO) Quant. • KRAS Qual., Mut. Detect. •
Varicella-Zoster Qual. • KRAS V2 (LSR) Qual., Mut. Detect. • *
Other pathogens EGFR V2 Qual., Mut. Detect. •
Chlamydia trachomatis/Neisseria gonorrhoeae Qual. • * • • PIK3CA (RUO) Qual., Ident. •
Chlamydia trachomatis Qual. • BCR-ABL (RUO) Quant. Relative •
Chlostridium difficile Qual. • • * Genetics
Methyllicin resistant staphylococcus aureus Qual., Diff. • • * • Factor V Leiden Qual., Mut. Detect. • * •
Mycobacteria Tuberculosis Qual. • * • Factor II Qual., Mut. Detect. • * •
Trichonomas vaginalis/Mycoplasma genitalis Qual. • * HLA-B * 5701 Qual. •
Vancomycin resistant enterococcus Qual. • Qual. = Qualitative; Quant. = Quantitative; Genot. = Genotyping;
Diff. = Differentiation; Ident. = identification; Mut. Detect. = Mutation Detection
* In development. ** Groups M and O.
RUO = For research use only. Not for use in diagnostic procedures.
Please check with your local Roche representative on availability of the assays and tests in your country. LSR = Life Science Research
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cobas® HPV Test

www.hpv16and18.com
Know the risk
Almost all cervical cancer is attributable Your benefit Product characteristics Test principle:
to HPV, so knowing a woman’s HPV Evidence based Coverage: • Multiplex assay to detect 12 pooled
status is important to ascertain her risk • Clinically validated in Roche’s landmark • Identifies (types) HPV 16 and HPV 18 high risk genotypes, with simultaneous
of cervical cancer and to determine ATHENA trial, the largest U.S.-based regis- while concurrently detecting the rest of individual genotyping for highest risk
clinical management. tration study for cervical cancer screening, the high risk types (31, 33, 35, 39, 45, 51, HPV 16 and 18
including more than 47,000 women 52, 56, 58, 59, 66 and 68) at clinically • Beta-globin acts as control for extraction
The cobas 4800 HPV Test is the only • One in 10 women in the landmark ATHENA relevant infection levels and amplification
c linically validated CE-marked, and FDA- study who tested positive for either HPV
approved assay for first-line, primary genotype 16 or 18 had evidence of cervical Sample material: Throughput:
screening of cervical cancer, that simulta- pre-cancer, even though their Pap cytology • Cervical cells collected in cobas® PCR • Up to 282 tests in less than 12 hours
neously provides results on a pool of test was normal cell collection media (Roche Molecular
“high-risk” g enotypes, including individual • Expanded U.S. indication to include Systems, Inc.), PreservCyt® solution
results on the highest-risk genotypes, screening of women ages 25 – 29 years (Hologic) and SurePath® preservative fluid
HPV 16 and HPV 18, giving three results in (not approved in the US)
just one test. HPV genotypes 16 and 18 Clinically relevant results (BD Diagnostics-TriPath)
are known to be responsible for more than • Knowing the patients HPV 16/18 status • Sample volume of 1 mL is sufficient
70 percent of all cervical cancer cases. may impact patient management and allow
better risk stratification for patients at the Absolute risk of ≥ CIN2 by screening strategies assessed in ATHENA at baseline
This test enables physicians to focus on the highest risk ≥CIN2 ≥CIN2
20
Risk of high-grade
few patients who need more aggressive
disease (%)
15 +
treatment or careful management, and Report with confidence +
10 Immediate referral to colposcopy
reassures the vast majority of women they • Cellular internal control for assurance
5 Pooled hrHPV+ HPV 16+ or 18+
are at very low risk, protecting them from of sample integrity (14.0 %) (11.4 %)
0
potentially unnecessary interventions. • No cross reactivity with low risk HPV ASC-US triage NILM adjunct screening
genotypes (≥21 years) (≥30 years)
1 in 10 women ≥30 years of age with negative cytology who tested positive for HPV 16/18 using the cobas HPV test
Efficiency had underlying precancerous lesions. Women with negative pap cytology who are HPV 16+ and/or HPV 18+ and
• Suited for high volume screening p
rograms women with ASC-US who are pooled hrHPV+ share a similar absolute risk of precancer and should be managed
• By fully automated sample preparation similarly with immediate referral to colposcopy.
workflow process, and unique efficiency
feature
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cobas® Oncology Portfolio

Seven to ten days is a long time
to wait when every day counts
The cobas ® Oncology Portfolio Your benefit Portfolio menu cobas ® EGFR Mutation Test v2
exemplifies Roche’s commitment to Reliable results cobas 4800 BRAF V600 Mutation Test
® • Identifies patients with non-small
Personalized Healthcare. The tests • Complete and controlled IVD system • Identifies which metastatic melanoma cell lung cancer who benefit from anti-
detect mutations in key biomarkers consisting of the cobas ® DNA patients can be considered for BRAF EGFR TKI therapy, e. g. Tarceva ®
which helps identify p atients who Sample Preparation Kit, the cobas ® inhibitor therapy, e. g. Zelboraf® in first-line therapy or TAGRISSO ™ in
are most likely to respond to certain cfDNA Sample Preparation Kit, • Detects V600E mutations of the BRAF subsequent-line therapy
drug treatments. These clinically cobas ® BRAF, KRAS, EGFR v2 and PIK3CA gene (< 5 % mutant copies in formalin- • Specific detection of 42 mutations
validated companion diagnostics help (RUO) Mutation Tests, and the fixed, paraffin-embedded tissue [FFPET]); (insertions and deletions) in exons 18, 19,
physicians make therapy decisions cobas ® 4800 System, v2.1 or higher also sensitive to V600K and V600D 20 and 21 of the EGFR gene (less than
for p
atients suffering from metastatic • 24 reportable results from a single test kit or equal to 5 % mutant copies in FFPET or
melanoma, colorectal cancer, and Consistent, objective and • Only requires one 5 µm tissue section with 2 mL of Plasma *)
non-small cell lung cancer. Due to the reproducible results > 50 % tumor area for the PCR reaction • 24 reportable results from a single test kit
short testing time, physicians can • Automated result interpretation and
make decisions in hours instead of days test reporting provide from laboratory cobas ® KRAS Mutation Test cobas ® DNA Sample Preparation Kit
when using alternative methods. to laboratory • Offers broad mutation coverage of KRAS • Clearly defined workflow
codons 12, 13 and 61 * to identify • Validated with FFPET samples
Fast result reporting colorectal cancer patients not likely to • Isolation time: 3 – 4 hours only
• Delivering patient results in < 8 hours respond to anti-EGFR monoclonal
when testing tissue, and < 4 hours when antibody therapies, e. g., Erbitux ®, Vectibix ® cobas ® cfDNA Sample Preparation Kit
testing plasma * • Detects all of the reported mutations in • Cleary defined workflow
codons 12, 13, and 61 * of the KRAS gene • Validated with plasma samples
* Not available in all tests and markets. (< 5 % mutant copies in FFPET) • Isolation time: ~2 hours
• 24 reportable results from a single test kit
• Only requires one 5 µm tissue sections with Assay specific analysis packages
≥10 % tumor area for the PCR reaction • Software package containing cycling
conditions, algorithms and calculations
* Not available in all markets. for automated interpretation and report
RUO = For research use only. Not for use in of results
diagnostic procedures.
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cobas® HSV 1 and 2 Test

Bring more to your sexually transmitted
infections menu
Due to extremely different outcomes Your benefit Mixed batch testing on cobas® 4800 System
regarding recurrence, it is essential to Amplified reliability
determine whether a patient has type 1 or • Robust, dual-target detection amplifies
type 2 herpes simplex virus. The cobas two separate regions on each of the
HSV 1 and 2 Test, which runs on the cobas HSV-1 and HSV-2 genomes
MRSA/SA samples C. difficile samples HSV 1 and 2 samples
4800 System, offers exceptional sensitivity • Optimizes sensitivity and specificity
while delivering reliable answers that • Ensures reliable results as new HSV
result in optimal patient treatment and strains emerge
management decisions.
Reduced hands-on time
• Just load your primary sample vials Automated sample preparation
on the cobas 4800 System and you’re with cobas x 4800 Instrument
ready to go
Unmatched flexibility MRSA/SA

• Run as few as 6 or as many as 94 samples C . difficile
• Process different tests and sample types

HSV 1 and 2
simultaneously
Amplification and detection

with cobas z 4800 analyzer
Parallel sample processing offers the flexibility

to run different tests and sample types, including:
• Stool (cobas Cdiff test)
• Nasal (cobas MRSA/SA Test)
• Anogenital lesions (cobas HSV 1 and 2 Test)
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cobas® Cdiff Test cobas® MRSA/SA Test

The right result the first time Faster than a spreading infection
Clostridum difficile (C. difficile) infection Your benefit Staphylococcus aureus (SA) and methicillin- Your benefit
is a major cause of diarrhea in healthcare Exceptional performance resistant Staphylococcus aureus (MRSA) Exceptional performance
facilities. By rapidly detecting Cdiff in • Selectively detects a specific Cdiff toxin infections represent a critical threat to • Quickly identify colonized patients and
patient stool samples, the cobas® Cdiff Test, gene directly from unformed stool s amples public health. The cobas MRSA/SA Test, take decisive action
which is performed on the cobas 4800 using real-time PCR performed on the cobas 4800 System, • Get the sensitivity and specificity that only
System, provides accurate information for • Generates robust results automatically, provides innovative solutions for detecting PCR technology can deliver
timely treatment and prevention. using patented, state-of-the art algorithms both organism variances from a single
• Detects the presence of 31 Cdiff toxino- nasal swab specimen, providing timesaving Greater workflow efficiencies
types and 20 ribotypes efficiencies and lifesaving answers. • Save time with first-of-its-kind primary
sample vial loading
Confidence in results • Run MRSA/SA, Cdiff, and HSV 1 and
• Lower inhibition rate minimizes invalids 2 samples at the same time, on the same
and need for repeat testing resulting in system
cost efficiency • Simplify data interpretation with patented,
• Reduces possibilities for errors state-of-the-art software algorithms
Unmatched flexibility Automated efficiency

• Run as few as 6 or as many as 94 samples • Run 6 to 94 specimens using the fastest,
• Process different tests and sample types most advanced real-time PCR amplification
simultaneously and detection available today
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cobas® HCV for use cobas® HCV

NEW
NEW
on the cobas® 6800/8800 System for use on the cobas® 4800 System
See what truly matters See what truly matters
The cobas® HCV quantitative nucleic acid cobas® HCV performance summary cobas® HCV quantitative nucleic acid test • Accurate detection and quantification
test for use on the cobas® 6800/8800 for use on the cobas® 4800 System, of HCV genotypes 1 through 6
Parameter Performance
Systems delivers robust, clinically relevant delivers robust, clinically relevant assay • High sensitivity suitable for use with
Sample type EDTA plasma, serum
assay performance based on Roche’s performance based on the proprietary new HCV therapies
Minimum amount 650 µL or 350 µL
proprietary dual-probe assay design. cobas® of sample required
dual-probe assay design from Roche with • Excellent correlation with the COBAS ®
HCV provides built-in redundancy with Sample processing 500 µL or 200 µL built-in redundancy for broad genotype AmpliPrep/COBAS ® TaqMan ® HCV
broad genotype coverage and incorporates volume coverage and improved mismatch tolerance Quantitative Test, v2.0
Analytical sensitivity 15 IU/mL (500 µL)
mismatch tolerance to ensure confidence (LoD by hit rate of 40 IU/mL (200 µL)
to ensure confidence in viral load
in viral load monitoring. cobas® HCV is ≥ 95%) monitoring. cobas® HCV performance
designed to deliver high sensitivity to Linear range 500 µL: 15 IU/mL – 1×10 8 IU/mL
200 µL: 40 IU/mL – 1×10 8 IU/mL Parameter Performance
meet the requirements of current and future Specificity 100 % (one-sided 95 %
cobas® HCV accurately detects
Sample types Serum, plasma
chronic hepatitis C therapies. confidence interval: 99.5 %) and quantifies all HCV genotypes
Sample processing 400 µL and 200 µL
Genotypes detected HCV genotypes 1– 6 1 through 6 volume
cobas® HCV delivers: • Two non-overlapping detection Sensitivity plasma: 9.2 IU/mL (400 µL);
Not commercially available in all countries. (LoD by PROBIT 15.2 IU/mL (200 µL)
• Tight precision at medically-relevant probes, when combined with
at ≥95 % hit rate) serum: 7.6 IU/mL (400 µL);
decision points two staggered primers, ensure assay 15.3 IU/mL (200 µL)
• Accurate detection and quantification performance Linear range 400 µL: 15 – 1×108 IU/mL
200 µL: 25 – 1×108 IU/mL
of HCV genotypes 1 through 6 • Mismatch tolerance to accurately
Precision 0.06 to 0.10 log10 S.D. across an
• High sensitivity suitable for use with quantify with high specificity despite HCV RNA concentration range
new HCV therapies changes in the viral genome of 1×103 – 1×107 IU/mL
Accuracy plasma: ±0.20 log10
• Excellent correlation with the COBAS® (across the linear (400 and 200 µL)
AmpliPrep/COBAS® TaqMan® HCV cobas HCV delivers:
® range) serum: ±0.23 log10 (400 µL);
±0.25 log10 (200 µL)
Quantitative Test, v2.0 • Tight precision at medically-relevant
Specificity plasma: 99.5 %
decision points (95 % confidence limit: 98.7 %)
5’
NT
R
COR
E E1 E2 P7 NS2
HCV RNA serum: 100%
(95 % confidence limit: 99.5 %)
NS
3 TR
NS
3’N
4A
NS
Not commercially available in all countries.
Two 4B
Forward Primer Reverse Primers N S 5A N S5 B
Dual JA270-labeled Probes
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cobas® HCV Genotyping COBAS ® AmpliPrep/

NEW
for use on the cobas® 4800 System COBAS ® TaqMan ® HCV qualitative
See what truly matters and quantitative Tests, v2.0
Empowering change in HCV
Identification of the infecting genotype is Automated assay providing COBAS ® AmpliPrep/COBAS ® Your benefit
required before a patient is prescribed workflow efficiencies TaqMan ® HCV qualitative Test, v2.0 • Reliable results by enhanced mismatch
antiviral therapy as response to treatment • Time to first result: <4 hrs and quantitative Test, v2.0 tolerance and coverage of all genotypes
correlates to the HCV genotype. • Generates up to 90 reportable results The version 2.0 tests are developed • Economic sample usage
Determination of HCV genotype prior in 8 hours with a lower input volume, and innovative • Excellent sensitivity to meet guidelines
to treatment initiation has been • Mixed batching capability with HIV-1 dual-probe design to provide improved
implemented in international HCV and HCV viral load tests on the sensitivity and precise detection across all Product characteristics
treatment guidelines. cobas® 4800 System genotypes for the new era of direct • Kit configuration 72 tests/kit
• Small sample processing volume: 400 μL acting antiviral agents (DAAs) to distinguish • Sample types EDTA plasma and serum
cobas® HCV GT is a highly sensitive true signal from background noise. • Sample input volume 650 µL
real-time PCR based test for the qualitative Sensitivity to meet clinical needs • Limit of detection 15 IU/mL
identification of HCV genotypes 1 to 6 The COBAS ® AmpliPrep/COBAS ® • Genotype inclusivity genotypes 1 through 6
Limit of detection (LoD)*
and genotype 1 subtypes a and b in human TaqMan ® HCV qualitative Test, v2.0 • Diagnostic sensitivity 100 %
Genotype Serum (IU/mL) Plasma (IU/mL)
plasma or serum from individuals with This test provides a qualitative molecular • Specificity 99.9 %
1a 125 125
chronic HCV infection, using the cobas® diagnostic tool in HCV diagnosis. It is
1b 125 250
4800 System. indicated for patients who have clinical Workflow
2 50 125
and/or biochemical evidence of liver • Confirm active infection and monitor HCV
3 125 125
cobas® HCV GT uses three different target disease and antibody evidence of HCV viral load on the same system
4 125 125
regions in the HCV genome (5’-UTR, Core, infection, and who are suspected to • Flexible batch size with continuous loading
5 500 1,000
NS5B) to achieve excellent genotyping and be actively infected with HCV. Detection • Interleave with other COBAS ® TaqMan ®
6 125 125
subtyping accuracy compared to sequencing of HCV RNA indicates that the virus is Tests (HIV-1, HBV)
and the capability to detect both genotypes * Lowest tested concentration with correct genotype replicating and therefore is evidence of
results in at least 95 % of tests Not commercially available in all countries.
in mixed infections down to a ratio of 1:100. active infection.
HCV genome organization and targets of cobas® HCV GT
5’-UTR C E1 E2 NS2 NS3 NS4B NS5A NS5S 3’-UTR
p7 NS4A
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cobas® HIV-1 for use on
NEW
the cobas® 6800/8800 System
Stay one step ahead
COBAS ® AmpliPrep/COBAS ® TaqMan ® Product characteristics It takes more than just a single target. cobas® HIV-1 performance summary
HCV quantitative Test, v2.0 • Kit configuration 72 tests/kit As the challenges you face evolve,
The test can be used to a ssess the • Sample types EDTA plasma and serum stay one step ahead with the cobas®
Sample type EDTA plasma, serum
probability of a sustained viral response • Sample input volume 650 µL HIV-1 quantitative test with a dual
Sample process 500 µL or 200 µL
early in a course of antiviral therapy • Limit of detection 15 IU/mL target approach. volume
and to assess viral response to antiviral • Linear range 15 IU/mL – 1E108 IU/mL Analytical sensitivity 13.2 cp/mL (500 µL)
treatment as measured by changes in • Genotype inclusivity genotypes 1 through 6 Rapidly mutating HIV-1 virus can evade 35.5 cp/mL (200 µL)
Linear range 500 µL: 20 cp/mL – 1.0E+07 cp/mL
serum or plasma HCV RNA levels. • Diagnostic sensitivity 100 % quantification with a single target viral load 200 µL: 50 cp/mL – 1.0E+07 cp/mL
• Specificity 100 % assay. cobas® HIV-1 quantitative nucleic Specificity 100 % (one-sided 95 %
Your benefit acid test for use on the cobas® 6800/8800 confidence intervat: 99.5 %)
Genotypes detected HIV-1M (A-D, F-H, CRF01_AE,
• Precisely distinguish true signals from Workflow Systems targets two unique regions of CRF02_AG), HIV-1O, HIV-1N
background noise for more accurate viral • Confirm active infection and monitor HCV the HIV-1 genome, gag and LTR, which are
load results viral load on the same system not subject to selective drug pressure.
• Reliable results by enhanced mismatch • Flexible batch size with continuous loading This a
pproach improves test sensitivity, Drive better decisions for a positive
tolerance and coverage of all genotypes • Interleave with other COBAS ® TaqMan ® coverage and security in the event of impact on patients’ lives
• Perfect tool to aid in response-guided Tests (HIV-1, HBV) mutation in one primer/probe region. • Targeting two regions improves genotype
therapy with excellent sensitivity and inclusivity, detects HIV-1 variants and
specificity delivering accurate results potentially avoids under quantification
• Economic sample usage required which • Accurate quantification of HIV-1 RNA
provides laboratory with enough left over with a dual target assay contributes to
sample for other laboratory testing optimal treatment decisions for patient
management
Roche offers a complete continuum of care to run the key tests for the diagnosis and
management of HCV
HCV antibody test HCV RNA quantitative test: HCV RNA quantitative
HCV RNA qualitative test: Confirmation Viral load monitoring test: Viral load
of antibody-positive specimens monitoring
Diagnosis Treatment On treatment Evaluate End of treatment
decision treatment and follow-up (SVR)
HCV RNA quantitative test: HCV RNA quantitative test:

Viral load monitoring Viral load monitoring
Key steps in the diagnosis and management of HCV
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cobas® HIV-1 COBAS ® AmpliPrep/

NEW
for use on the cobas® 4800 System COBAS ® TaqMan® HIV-1 Test, v2.0
Stay one step ahead A dual-target approach for greater security
against the unexpected
It takes more than just a single target. Drive better decisions for a positive An in vitro nucleic acid amplification Your benefit
As the challenges you face evolve, impact on patients’ lives test for the quantitation of HIV-1 RNA in Dual-targeted approach for greater security
stay one step ahead with the cobas® • Targeting two regions improves genotype human plasma. against the unexpected:
HIV-1 quantitative test with a dual inclusivity, detects HIV-1 variants and • Provides diagnostic accuracy of test
target approach. potentially avoids under quantification This test enhances the reliability of test results even if mutations occur in one
• Accurate quantification of HIV-1 RNA results and provides greater confidence of the two regions
Rapidly mutating HIV-1 virus can evade with a dual target assay contributes to in assessing viral loads. It also increases • Compensates for the possibility
quantification with a single target viral load optimal treatment decisions for patient the probability of detection and expands of mismatch occurring with a primer/
assay. cobas® HIV-1 quantitative nucleic management coverage by targeting two highly conserved probe region
acid test for use on the cobas® 4800 regions of the HIV-1 genome to compensate • Ensures enhanced reliability of test
System targets two unique regions of the cobas® HIV-1 performance summary for the possibility of mutations or mis- results and more confidence in assessing
HIV-1 genome, gag and LTR, which are not matches. The test provides diagnostic viral loads
subject to selective drug pressure. This accuracy in test results even if mutations • Offers increased sensitivity and linear
Sample types EDTA plasma
approach improves test sensitivity, coverage occur in one of the two regions. range for accurate measurement of
Sample process 400 µL or 200 µL
and security in the event of mutation volume
viral suppression
in one primer/probe region. Analytical sensitivity 14.2 cp/mL (400 µL) This test uses the COBAS ® AmpliPrep
43.9 cp/mL (200 µL) Instrument to automate specimen processing
Linear range 400 µL: 20 cp/mL – 1.0E+07 cp/mL
200 µL: 60 cp/mL – 1.0E+07 cp/mL
and the COBAS ® TaqMan ® Analyzer or
Specificity 100 % (one-sided 95 % COBAS ® TaqMan ® 48 Analyzer to automate
c onfidence interval: 99.5 %) amplification and detection.
Genotypes detected HIV-1M (A-D, F-H, CRF01_AE,
CRF02_AG), HIV-1O, HIV-1N
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COBAS® AmpliPrep/
COBAS® TaqMan® HBV Test, v2.0
The trusted choice for Hepatitis B
viral load testing
Product characteristics • Offers increased sensitivity and linear Improve patient management and treatment Your benefit
• Offers primers and probes that are range for accurate measurement of viral success. • Confidence in assay design with opti-
used to amplify the gag and LTR regions suppression mized primer-probe selection targeting
• Provides LTR primers that have • Has a lower limit of detection (LOD) Fully automated viral load quantitative highly conserved pre-core and core
broad genotype inclusivity and are and 100 % specificity at 20 copies/mL than hepatitis B test used in the management of regions. The amplified region of the
well conserved phylogenetically previously available HIV-1 tests patients with chronic hepatitis B infection genome will not be affected by mutations
• Quantifies the clinically significant • Is fully traceable to WHO international undergoing antiviral therapy. that arise due to drug resistance
HIV-1 groups and subtypes with full standards
subtype coverage and quantification The test provides clinically relevant assay • Confidence in detection with multiple
of HIV-1 groups O and M performance, and high sensitivity to layers of contamination control including
• Quantitates HIV-1 RNA from deliver optimal results throughout critical built-in AmpErase enzyme, optimized
20 – 10,000,000 copies/mL medical decision points and across all pipetting and workflow settings and
genotypes, all combined with fully automated verified low rates of cross contamination
sample extraction and real-time PCR
amplification and detection for a highly • Confidence in measuring HBV DNA with
efficient laboratory workflow. high precision at medical decisions points
translates into confidence in each result
regardless of HBV DNA level
• Confidence through clinical validation –

Roche HBV viral load tests have been the
most widely used tests in pharmaceutical
trials worldwide providing a link between
clinical practice and clinical trials
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COBAS® AmpliPrep/
COBAS® TaqMan® CMV Test
Setting the standard in assessing virological
response in CMV infection
Roche HBV Tests in clinical trials for approved HBV drugs on the market Improve disease management and patient Your benefit
care with a Roche real-time, fully automated With the COBAS® AmpliPrep/COBAS®
Generic Name Trade Name Date FDA Approved
PCR test. TaqMan® CMV Test, you can be reassured
Interferon alfa-2b INTRON® A 1991
that you are requesting:
Lamivudine EPIVIR-HBV ®
1998
Cytomegalovirus (CMV) is a leading cause
Adefovir dipivoxil HEPSERA™ 2002
of morbidity and mortality in transplant • A test that fulfils international guideline
Entecavir BARACLUDE™ 2005
recipients. Severe CMV infection in recommendations – demonstrating
Peginterferon alfa-2a PEGASYS® 2005
high risk patients may develop soon after co-linearity to the WHO international
Telbivudine TYZEKA™ 2006
transplantation and without effective standard and reports results in IU/mL,
Tenofovir VIREAD (HIV) 2008
treatment, may lead to CMV syndrome, as recommended by the international
tissue invasive disease, and potential consensus guidelines for CMV manage-
rejection or loss of the graft. Roche’s CMV ment in solid organ transplant patients 1,8
Test reliably monitors Cytomegalovirus
(CMV) infection in patients receiving anti- • A test that is clinically validated – Used in
viral therapy. key clinical studies, demonstrating clinical
utility of CMV viral load monitoring 3,9
• A test that provides reproducible and

reliable results – proven to provide reliable,
comparable and reproducible viral load
results across different institutions, over
several orders of magnitude.6 The first
standadized CMV viral load test with CE
and FDA approval 8
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COBAS® TaqMan® MTB Test

Rapid MTB detection
CMV viral load test standardization enables improvement in CMV infection Tuberculosis is the world’s most common Your benefit
management4,5 infectious disease, with two million deaths • Fast results in only 3.5 hours including
annually. Due to the risk and severity of sample preparation
Comparability of the Roche CMV Test results Comparability of LTD results across five the disease, rapid diagnosis of the M. tuber • Reliability of test results
across five laboratory testing sites laboratory testing sites culosis-complex is extremely important. – high sensitivity and specificity
Routine cultures are time-consuming and – clear differentiation of the pathogen
can take up to eight weeks. Microscopic from atypical mycobacteria (MOTT)
examination of acid-fast smears is insensi- – contamination protection through
tive and nonspecific. The COBAS TaqMan AmpErase System
MTB test has further improved the rapid • Efficient workflow, no manual steps
diagnosis of tuberculosis by allowing required after sample preparation
direct detection of mycobacteria in clinical • Proven and safe sample preparation with
specimens. the A MPLICOR respiratory specimen
preparation kit
1 Asberg, A., Caliendo, A. M., Chou, S., Kotton, C. N., Kumar, D. et al. (2013). Updated international consensus
guidelines on the management of cytomegalovirus in solid-organ transplantation. Transplantation 96, 333-360.
3 Åsberg, A., Boisvert, D., Caliendo, A.M., Do, T.D., Rollag, H,, Duncan, J., Humar, A., Razonable RR, Yao, J.D. (2013).
Virologic suppression measured by a cytomegalovirus (CMV) DNA test calibrated to the world health organization
international standard is predictive of CMV disease resolution in transplant recipients. Clin Infect Dis. ;56:1546–1553.
4 Caliendo, A. M., Fenton, J. M., Fox, J. D., Miller, G. G., Pang, X. L. et al. (2009). Interlaboratory comparison of cyto-
megalovirus viral load assays. Am J Transplant 9, 258-268.
5 Abdul-Ali, D., Caliendo, A. M., Ingersoll, J., Schaper, C., Shahbazian, M. D. et al. (2009). A commutable cytomegalovirus
calibrator is required to improve the agreement of viral load values between laboratories. Clin Chem 55, 1701-1710.
8 COBAS® AmpliPrep/COBAS® TaqMan® CMV Test package insert data
9 Åsberg, A., Hartmann, A., Humar, A., Jardine, A. G., Mouas, H., Noronha, I.L., Pescovitz, M. D., Rollag, H.,
Sgarabotto, D., Tuncer, M., and on behalf of the VICTOR Study Group (2007), Oral Valganciclovir Is Noninferior to
Intravenous Ganciclovir for the Treatment of Cytomegalovirus Disease in Solid Organ Transplant Recipients. Am J
of Transplant, 7:2106–2113 COBAS TaqMan 48 Analyzer and MTB kits
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LightCycler® MRSA Advanced Test

Enabling improved infection control
Product characteristics The incidence of hospital-associated Your benefit

• Detects pathogens of the Mycobacterium methicillin-resistant Staphylococcus aureus • Fast results: Results available within
tuberculosis complex (M. tuberculosis, (MRSA) is on the rise around the globe. 100 min.
M. bovis, M. africanum, M. microti) Studies in Europe and the United States • Simple: Sample preparation procedure
• Test is performed on the IVD CE-marked suggest that 28 – 34 % of patients infected involves no pipetting steps
COBAS TaqMan 48 Analyzer that allows with MRSA will even die from their infec- • Flexible: Validated for use with
variable batch sizes – between 1 and tion. These findings have serious implica- 3 different swabs and provided in
48 tests per run tions for patients, physicians, and hospitals. a convenient, ready-to-use format
• Internal controls included in the same The increased rates of MRSA also have • Reliable results: The only rapid MRSA
reaction batch significant economic implications. test containing the Roche AmpErase®
• Specificity: 99 % enzyme, able to prevent carry-over
• Sensitivity: 0.46 CFU/PCR, corresponding The LightCycler MRSA Advanced test amplicon contamination that lead to
to a calculated concentration of offers a simple, flexible and reliable way false positive results
18 CFU/mL sputum to incorporate MRSA surveillance into
your hospital’s infection control program.
Ensure fast and simple operation
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cobas® 6800/8800 Systems

www.cobas68008800.com
Own the future
The cobas 6800/8800 Systems are new Your benefit Product characteristics
molecular testing platforms, available in Unparalleled Performance eady-to-use reagents do not
R Uni- and bi-directional LIS
medium and high throughput models, Rapidly complete daily testing requirements require thawing, mixing or pouring interface simplifies order and
designed for donor screening, viral load with trusted and reproducible results. result handling
monitoring, women’s health, and utomated onboard storage and
A
micro-biology testing. Absolute Automation refrigeration system enable ready ystem connectivity: up to five
S
Allows you to focus on more complex testing access and maintain inventory of analytic systems and four cobas
The cobas 6800 System and the higher demands while increasing productivity within consumables and reagents p 680 instruments managed
throughput cobas 8800 System are the lab. by a single instrument gateway
designed to be readily integrated into R adio-frequency identification
laboratory workflow from pre-analytic Unmatched Flexibility (RFID) and barcodes ensure Gain valuable “work-away” time
to post-analytic solutions. Run the tests you want when you want full traceability from sample in by consolidating your LDTs with
For more information visit www.cobas68008800.com with minimal user interactions. to results out routine IVD tests with the cobas
omni Utility Channel
Automated pre-analytic sample handling
Consolidated menu
Offers a broad and expanding menu to meet your needs today and in the future.
Blood Screening Viral Load Diagnostic Testing * Dual-target for HIV-1 and dual-probe for HCV
cobas p 312 Today Monitoring Tomorrow ** ** Currentliy in development
cobas p 512 cobas p 612 cobas connection
®
† Dual-target
pre-analytical system pre-analytical system pre-analytical system modules MPX* HIV-1† CT/NG †† Dual-probe
+ + WNV HBV HPV

Virus
Bacteria
Sorting Decapping Tube type Sample Aliquoting with barcode
ID volume labelling DPX HCV†† MTB/MAI
The cobas ® 6800/8800 Systems are not available
detection
HEV CMV HIV Qual in all markets.
Fully automated,
Sample Recapping multidisciplinary up to up to
quality connectivity 3 84 9 60
Archiving Recursive
te
te
sts
sts
workflows
*
Centrifu- Bulk 8 hours 4 hours
gation loading work-away work-away
time* time*
450 sample/hour 1,100 samples/hour 1,100 samples/hour
* m ay vary based on workflow demands
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cobas® 4800 System

Works the way you do
The cobas® 4800 System offers state-of-the- Your benefit Test menu
art, fully automated sample preparation, Reliable results
Virology Microbiology & Genomics & Oncology Diagnostic testing
real-time PCR amplification/detection and • Proprietary kinetic algorithm software Women’s Health tomorrow **
easy-to-use software for multiple sample provides clear and precise answers HIV-1 † HPV BRAF TV/MG
types (the detection of C. trachomatis (CT), reducing the need for retesting or HBV CT/NG KRAS Factor II/V
N. gonorrhoeae (NG), HPV (human interpretation
HCV †† HSV-1/2 EGFR V2 KRAS Plasma
papillomavirus) virology and an expanding
menu of assays. Efficiency HCV GT C.diff
• By fully automated sample preparation
MRSA/SA
It consists of the cobas x 480 Instrument and PCR set-up (for HPV, Virology,
for the nucleic acid extraction sample and CT/NG) ** Currently in development Virus
† Dual-target
Bacteria
preparation and PCR pipetting and the • By bidirectional connectivity with your †† Dual-probe
Variant
obas z 480 real-time PCR analyzer.
c LIS for automated results reporting
The cobas z 480 analyzer is also available Flexibility • Processes up to 376 samples in 10 h • Easy to use software
as single system and can be used for • Possibility to use multiple primary vial types • Bidirectional connectivity to LIS • Automated result interpretation
parameters in the oncology field like BRAF, • User defined workflow software for free for HPV and CT/NG
KRAS and EGFR. programmable PCR applications
cobas ® Pre-analytic Systems
Load-and-go reagents
• Save time and labor Primary & secondary automated
pre-analytical sample handling
• Low daily maintenance requirements
Decapping Recapping
Aliquoting Reagent addition

& heating
cobas p 480 Instrument
for use with cobas® 4800 System Four customizable workflows
cobas x 480 Instrument cobas z 480 analyzer
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COBAS ® AmpliPrep/
COBAS ® TaqMan ® System
Easy Begins Here
The COBAS ® AmpliPrep/COBAS ® Your benefit Product characteristics • Up to four independent thermocyclers,
TaqMan ® System, a real-time PCR system, Safety and reliability COBAS ® AmpliPrep Instrument each with 24 positions
unites primary tube handling with fully • Closed tubes for samples and purified • Ready-to-use reagents in barcoded • Run time: 2.5 – 3.5 hours
automated sample preparation, amplification nucleic acids minimize contamination cassettes • Run up to 192 samples in 24 hours
and detection of RNA or DNA. The • Sample tracking with barcoded tubes • Complete 72 samples; up to 144
easy-to-operate system provides high prevents sample mix-ups purifications per day or approximately Test menu
throughput processing for a menu 15 – 24 samples/hr With manual sample preparation
of important molecular tests including HIV, Efficiency • Detection of liquid level and clots • HCV quantitative
HCV, HBV, and CMV. The system • Handles up to four tests simultaneously; • Controllable via data station with • HBV quantitative
improves workflow efficiencies with the continuous reloading during the run AmpliLink ® software, for laboratory • HIV-1 quantitative
COBAS® AmpliPrep Instrument for • Ready to use reagents – no aliquotting or integration with LIS • Chlamydia trachomatis qualitative
automated extraction of DNA and RNA mixing required • Barcoded data input • Mycobacterium tuberculosis qualitative
using magnetic bead technology • Overnight runs
and the COBAS® TaqMan® or COBAS® • Additional generic sample preparation for COBAS ® TaqMan ® Analyzers With automated sample preparation
TaqMan® 48 Anayzers for automated other PCR systems increases the versatility • A docking station can combine • HCV qualitative and quantitative
real-time amplification and detection of of the instrument COBAS ® AmpliPrep Instrument and • HBV quantitative
DNA or RNA for up to 96 samples COBAS®TaqMan ® Analyzer into • CMV quantitative
and four assays at the same time. Reliability for routine PCR a single, fully automated system that • HIV-1 quantitative
• Reliable results within two to three hours can perform sample preparation, • HLA–B * 5701
• Sensitive, highly linear tests can PCR set-up and amplification/detection • HIV-1 qualitative *
handle both low titer and high titer
samples in the same run * Not commercially available in all countries.
• Greater safety due to AmpErase enzyme

contamination prevention and
internal controls for detecting possible
PCR inhibitors
COBAS® TaqMan® 48 Analyzer COBAS ® AmpliPrep/COBAS ® TaqMan ® System
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cobas® Liat System

www.cobasliat.com
We put a lab in a tube, because they put their
trust in you
The cobas Liat System incorporates Roche Your benefit Product characteristics
real-time PCR technology in a compact, fully Accuracy • No complex set up
automated bench top analyzer. • Roche PCR technology • Runs single assays on single
• Definitive, reproducible, objective patient samples
The self-contained cobas Liat Analyzer • All assay components fully enclosed — no
and its uniquely segmented assay tubes Speed direct operator contact with reagents or
allow the efficient use of Roche PCR in the • Analysis in less than 20 minutes, other solutions
time-sensitive analysis of individual patient to expedite diagnosis and treatment • Easy, 3-step process
samples — with definitive results generated • Single-sample testing, to enable • Definitive, objective results
in less than 20 minutes. immediate response • Over 20 controls including comprehensive
real-time monitoring
Closed-system design and multiple process Ease-of-use • Touchscreen options allow viewing of
controls make it ideal for adoption by satel- • No technical training required real-time PCR curve
lite labs, physician offices and pharmacies. • Touchscreen-guided operation, • Printer connectivity for report outputs
minimizes potential for human error
Analyzer dimensions and weight
Safety 24.1 × 11.4 cm × 19.0 cm, 3.76 kg
• Multiple process controls
• Completely closed system cobas® Liat Assay Menu
• Minimal risk of contamination
cobas Influenza A/B
Space-Efficiency cobas Influenza A/B + RSV *
• Small bench top footprint cobas Strep A
Additional assays in development
* Not available in all markets including the US.
Sample Scan Start
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cobas s 201 System

The first multi-dye nucleic acid testing (NAT)
screening system
The cobas s 201 system is a complete Your benefit Product characteristics cobas® TaqScreen DPX Test
NAT solution able to meet both current and • Full automation including optional pooling Scalable, modular system • Simultaneous quantitative detection
future needs of blood screening labs. and archiving with minimal hands-on time • Flexible, mix-and-match scalability helps of parvovirus B19V DNA and qualitative
for the entire testing process NAT labs work more efficiently detection of HAV
This system provides the efficiency • Confidence in the test results through full • Supports simultaneous multiple assay • B19V target values are traceable to the
and reliability of real-time polymerase process control processing WHO B19V International standard
chain reaction (RT-PCR) technology, • Comprehensive assay menu with ready- • Accommodates integrated backup to
modular automation, convenient ready- to-use reagents maximize lab productivity cobas ® TaqScreen WNV Test
to-use reagents and a r obust menu • Built-in viral target resolution through • Qualitative in vitro test for the direct
selection. New assays utilize multi- multi-dye technology makes confirmation Pooling and data management server detection of West Nile virus (WNV) RNA
channel capabilities to provide real-time testing obsolete • Single server, accommodating multiple in human plasma
discrimination of major viruses. instrument configurations and providing • Screening test for donations of whole
the added security of built-in redundancy blood and blood components
The system is backed by world-class • Capable of detecting other members
service and strong local support in over Test menu of flavivirus that have been implicated in
140 countries. • Reagents are ready-to-use with built-in fusion transmitted infectious disease
contamination control
• No freezers required, reagents are stored
at 2 – 8° C
• Stabilized reagents obsoletes calibrations
Pooling and data management server cobas ® TaqScreen MPX Test, v2.0
• Cover 5 critical viral targets (HIV-1
Group M, HIV-1 group O, HIV-2, HCV
and HBV) in one easy-to-use assay
• Immediate virus discrimination in a single
assay, no need for virus discriminatory
testing
Hamilton MICROLAB STAR COBAS® AmpliPrep Instrument and
Pipettor instrument for automated pooling COBAS® TaqMan® Analyzer combined
with a docking station
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FLOW Solution
NEW
ldtsolution.roche.com/FLOW
Unleash your potential
The Roche FLOW Solution delivers ultimate FLOW Flex

flexibility based on your instrument • Offers medium-throughput capabilities
configuration. It offers complete workflow • Uses one pipetting instrument for
standardization and data automation for improved cost effectiveness
your entire lab developed testing process.
By moving your sample information from FLOW Classic
your lab information system through all • Offers high-throughput capabilities
instruments with complete data safety and • Uses two pipetting instruments for higher
sample tracking, the FLOW Solution throughput capabilities
enables you to generate accurate results Your benefit
with less effort than ever before. Stay Flexible Increase Productivity
The FLOW Solution helps you stay ahead The FLOW Solution delivers automation
of a quickly shifting market: and higher throughput:
• React quickly and effectively to changing • Process more samples with less effort
environments • Minimize hands-on time
• Make use of self-developed assays or • Report more than 2,000 results in less
solutions supplied by Roche than 8 hours
• Adapt a highly modular instrument setup
Primary Sample Nucleic Acid qPCR Setup Amplification The FLOW Solution is for General Lab Use.
Purification Detection
to your needs
Ensure Result Safety

The FLOW Solution delivers more accurate
results:
• Utilize a completely paperless data
transfer process
• Enables software connectivity between
Roche Primary MagNA Pure 96 Roche PCR Set-up Roche qPCR the lab LIS and FLOW Solution
Sample Handling Instrument
• Use the Roche process control to monitor
the workflow
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LightCycler® Systems
www.lightcycler.com
Excellence in real-time PCR
Whether your interest is in gene expression Your benefit Available reagents

profiling or in detecting genetic variations, High precision • Generic kits for qPCR and RT-qPCR
there is a member of the LightCycler® • Reproducible results independent of • Parameter-specific kits Research Use Only
System family offering the analytical perfor- the sample position including assays from TIB MOLBIOL for
mance and throughput you need for your pathogen detection
research. High flexibility • Parameter-specific kits IVD
• Suitable for all common assay formats • Ready to use custom assays and panels
Supported by a broad range of software and dyes for all available LightCycler® Systems
tools, real-time PCR based analysis can be (e.g., Universal ProbeLibrary and RealTime
performed in 32 capillaries or plastic tubes, High sensitivity ready)
interchangeable 96-/384-well plates, or • Even single copies can be detected • Optimized line of LightCycler® consumables
using the unique 1536-well formats.
High operator convenience Product characteristics
For additional information, visit • Data analysis according to your needs LightCycler® 2.0 System LightCycler® 96 System LightCycler® 480 System (96/480)
lifescience.roche.com or www.lightcycler.com
Throughput 32 reactions 96 reactions 96 or 384 reactions
Versatility Hardware 6 detection channels 4 excitation and 5 excitation and
• Absolute or relative quantification, 4 detection filters 6 detection filters
melting curve analysis or genotyping – Disposable Capillaries 96 multiwell plates 96 or 384 multiwell plates
or tube strips or tube strips
the software offers all options System features • Excellent temperature homogeneity in all wells/vessels
• No need for passive reference dyes
• 40 cycles are possible in 40 minutes
• Freely programmable protocols, data import and export, creation of macros, and templates.
Assay formats SYBR Green I, hydrolysis SYBR Green I, hydrolysis SYBR Green I, hydrolysis and
and hybridization probes probes hybridization probes
Applications • Absolute Quantification • Absolute Quantification • Absolute Quantification
• Relative Quantification • Relative Quantification • Relative Quantification
• Tm Calling • Tm Calling • Tm Calling
• Melt-Curve Genotyping • Endpoint Genotyping • Melt-Curve Genotyping
• Endpoint Genotyping • Qualitative Detection • Endpoint Genotyping
• Qualitative Detection • High-Resolution Melting • Qualitative Detection
(HRM) • High-Resolution Melting (HRM)
• Multiple Plate Analysis
LightCycler ® 2.0 LightCycler ® 96 System LightCycler ® 480 System LightCycler® 2.0 Instrument is available as IVD in many countries.
System (IVD) Information about the high-throughput LightCycler® 1536 System is available on request.
For life science research only.
Not for use in diagnostic procedures unless otherwise noted.
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LightCycler® 2.0 Instrument

For medical research
The LC 2.0 System is a proven standard of Your benefit Product characteristics

excellence with its high precision thermo • Safety and ease of use in the IVD mode, • Compact benchtop model
cycling, state-of-the-art quantification including test-specific reagent kits, and • Fast run of 35 cycles in 40 minutes
software, and numerous high-quality kits PCR macros that can automate instrument • Reaction batch of 1– 32 samples 20 μL
for a wide range of applications in in vitro programming, test analysis and result or 100 μL capillaries
diagnostics and in medical research. reporting • 6 detection channels for 530, 560, 610,
• The research mode offers flexible 640, 670, and 710 nm Data display for a qualitative detection analysis
It generates fast and reliable results programming, editing and user evaluation • Versatile detection formats: SYBR Green,
through its innovative features, including - Versatility in application options e.g., hybridization probes, hydrolysis probes,
the single air-driven chamber, which en- qualitative and quantitative detection, SimpleProbe probes, Scorpion primers,
sures ultra-precise temperature regulation mutation detection by melting curve and other FRET-based detection formats
for the highest accuracy and reproducibility. analysis and SNP genotyping
- Broad choice of detection formats Test kits, validated for IVD
• CMV quantification
• EBV quantification
• HSV 1/2 detection and differentiation
• VZV detection
• MRSA advanced detection Genotyping analysis
• SeptiFast identification of bacteria
* More details on following page.
and fungi
• SeptiFast mec A resistance screening
• Factor V mutation detection
• Factor II mutation detection
For medical research

• HAV quantification
• Parvo B19 quantification
LightCycler ® 2.0
• VRE resistance screening
System (IVD) • Translocation (9;22) quantification
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MagNA Pure Systems

starthere.roche.com
Breakthroughs have a beginning
Your genomic workflow begins with Your benefit

nucleic acid purification. Roche Molecular • Extract a wide range of starting materials
Diagnostics has revolutionized automated • Simplified sample preparation for
sample preparation with nearly 2 decades dramatic reduction of handling errors
of expertise. Enhancing your laboratory • Preloaded protocols for a broad range
workflow, the MagNA Pure Systems offer of sample types
automated, flexible, and consistent • Pre-filled and barcoded reagent kits
solutions. • Intuitive software and guidance Discover the right solution for you
Start confidently and increase your workflow efficiency with Roche manual and automated
solutions. Use the table below to guide your next nucleic acid extraction.
MagNA Pure MagNA Pure LC 2.0 MagNA Pure 96

Compact System System System
# of Samples 1 – 8 samples per run 1 – 32 samples per run 1 – 96 samples per run
Run Time ~30 min. ~1 hour ~1 hour
Starting Samples Whole Blood, Plasma, Serum, Cell Culture, Tissue, Body Fluids, Fresh Frozen and FFPE
Tissue, Swab, Stool, Sputum
Nucleic Acid Targets Genomic and Bacterial DNA, Viral DNA/RNA, Plasmid DNA and Total RNA
MagNA Pure Compact and MagNA Pure LC 2.0 Systems are for general laboratory use.
MagNA Pure MagNA Pure LC 2.0 System MagNA Pure 96 System MagNA Pure 96 Systems are for in vitro diagnostic use.
Compact System
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cobas p 480 instrument

Automating your primary vial
preprocessing steps
The cobas p 480 instrument improves Product characteristics Reduces hands on time and repetitive motions with four unique workflows
laboratory efficiency by allowing valuable Improves sample reproducibility and
technician time to be used more productively, process reliability
eliminating repetitive, manual sample • Sample chain of custody is assured
handling, improving workflow and reducing with primary and secondary vial barcode
risk of contamination, human error and matching
workplace injury. • All vials are spun prior to opening to
remove potentially contaminating droplets 1 2
Your benefit from sample caps
Decapping Recapping
Improving laboratory efficiency • Precision pipetting using CO-RE tip, Total
Removes caps from primary tubes for testing Recaps sample vials with new caps to avoid
• Accepts PreservCyt®, SurePath™ liquid Aspirate and Dispense Monitoring and on the cobas® 4800 System. contamination.
based cytology vials as well as Anti-Droplet Control technologies reduce
cobas® PCR Media and cobas® PCR Cell opportunities for contamination and
Collection Media primary vials ensure sample integrity
• Processes four vials simultaneously • No LIS or data connection required
• Intuitive interface requires minimal training • Printable reports capture all sample
• High throughput automation allows a ID’s, sample error and reagent lot and
single cobas p 480 instrument to support expiration information 3 4
up to two cobas® 4800 Systems, delivering
Aliquoting Reagent addition and heating *
Aliquots configurable volumes from PreservCyt®, Addition of cobas® Sample Prep Buffer and
Up to 376 cobas® SurePath™ and cobas® PCR Cell Collection incubation of specimens collected in SurePath™
376 4800 System results Media primary vials into barcode matched medium to reverse cross-linking and free
in 8.7 hours secondary tubes Compatible with SurePath™ nucleic acids for testing1.
vials with plastic inserts.
Up to 470 cobas®
1 Kiernan, J.A. Preservation and retrieval of antigens * c obas® Sample Prep Buffer and use of SurePathTM
470 4800 System results for immunohistochemistry – methods and Medium with the cobas® HPV Test are not approved by
in 8.5 shift * mechanisms Part 2. Retrieving masked antigens
the FDA for use in the United States.
Department of Anatomy and Cell Biology.
The Cutting Edge, 5-11.
Decapping workflow using 1 cobas p 480
instrument and 2 cobas® 4800 Systems.
* Final run completes overnight.
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The pre-analytics solution that makes life easier
The cobas p 630 instrument offers in Your benefit Product characteristics

combination with the COBAS® Efficiency • Uncapping and recapping of the
AmpliPrep/COBAS® TaqMan® System • Automated handling of primary and sample tube
a fully automated pre-analytical secondary tubes • Pipetting Roche controls from control
solution for primary tube handling. tubes to sample tubes
The system automatically pipettes Flexiblility • Pipetting samples from primary and
primary and secondary tubes and • Compatible with a variety of sample tubes secondary tubes to sample tubes
controls into sample input tubes • Modular design • Multiple tests can be ordered on a single
for the COBAS ® AmpliPrep Instrument. primary tube
Full traceability • Only one LIS interface required
The cobas p 630 instrument can • Barcode tracking from patient tube to result
be combined with up to three Unit dimensions
COBAS ® AmpliPrep Instruments Process surveillance • 112 cm wide, 101 cm deep, 90 cm high
and AmpliLink software to • Monitors liquid handling
ensure full traceability of workflow. Sample processing throughput
• 320 samples on board
• 154 tubes per hour for 650 μL samples
• 149 tubes per hour for 1.0 mL samples
• 157 tubes per hour for 500 uL samples
cobas p 630 Instrument
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Supports the creation of sample pools for use
with the cobas® 6800/8800 Systems
The cobas p 680 instrument automates Your benefit Product characteristics

the creation of pools in secondary tubes Improved workflow efficiencies Flexible Pool Creation
and pipetting of samples into aliquot plates • Automated loading of racks onto Creation of pools with fewer samples than
for archiving. From a deck capacity of 500 instrument, once rack tray is deposited the configured pool size (e.g., creation of
tubes, primary pools of 1, 6, 24, 96 and 480 • Error lane allows user to easily identify a pool of six with five samples); additional
may be created. The instrument utilizes tubes with pipetting errors aliquots will be taken from samples to
Roche standard 5-position racks and rack complete the pool. Aliquot plates may be
trays to help streamline workflow with Confidence in full traceability created offline for sample archiving.
Roche pre-analytics and analytic systems. • Full integration in the cobas 6800/8800
The cobas p 680 instrument combines Systems software ensures full traceability TADM
proprietary pipette tip technology and liquid of sample pool creation to final result Total aspiration and dispense monitoring
level monitoring to ensure reliable sample • Secondary tubes are barcoded for (TADM) of the pressure within the pipette
transfer during pooling. Connect up to improved workflow efficiency and full tip during the pipetting process ensures
four cobas p 680 instruments to the cobas® traceability accurate sample transfer.
6800/8800 Systems to meet your lab’s needs.
Liquid level detection
Capacitive liquid level detection monitors the
level of sample in a tube or plate to prevent
overflow and carryover contamination during
pipetting.
CO-RE tip technology

Compressed O-ring expansion (CO-RE) tip
technology locks pipette tips in place with
an expanding O-ring. The tip is released
when the O-ring gently decompresses,
preventing the creation aerosols to minimize
contamination. Disposable filter tips are
utilized to prevent cross-contamination.
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Roche Blood Safety Solutions
Safe blood supply Blood screening laboratories are managing

critical workflow processes and provide
uninterrupted service to ensure timely release
The cobas systems are designed to
efficiently fulfill the demanding safety and
reliability blood bank standard. All
Nucleic Acid Testing of safe blood products. supported by a first-class team of skilled
professionals in your area who are
Serology Roche understands that challenge and

is dedicated to be a trusted partner now
ready to respond when needed most.
Blood screening laboratories and in the future.
Pre-analytics Roche Blood Safety Solutions offers a

comprehensive portfolio through
Personalized Lab Automation which
IT solutions integrates nucleic acid testing, serology
Reliable results
testing, pre-analytics and IT solutions.
Roche is the first company to offer a
connectivity of serology and nucleic acid
Full automation testing, setting new standards in your

daily routine.
Roche Blood Safety Solutions

Efficient processes
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Roche Blood Safety solution

NEW
Striving for continual improvement to meet

blood banks’ evolving needs
Your benefit Test menu

Reliability Safety Serology: NAT:
• Innovative technologies tailor-made to • State-of-the-art assay sensitivity and anti-HCV II anti-HAV TaqScreen MPX
meet individual needs genotype coverage allow reliable anti-HAV-IgM HTLV-I/II TaqScreen MPX, v2.0
• Systems which have the highest detection at the earliest detectable stage HBsAg II HBsAg II qu. Chagas TaqScreen WNV
reliability on the market while preventing of infection in all parts of the world anti-HBs II TaqScreen DPX
HIV combi PT HIV-Ag
cross-contamination and offering • Highly standardized processes which anti-HBc cobas® MPX
full s ample traceability reduce manual handling and risk of anti-HBc IgM CMV IgG Rubella
Basic Chart cobas® WNV
error HBeAg
CMV IgM Rubella IgM
cobas® DPX
Efficiency anti-HBe
CMV IgG av. Toxo IgG
• High assay specificity and the innovative

multi-dye technology reduce the need
A fully integrated HSV-1 IgG Toxo IgM cobas® HEV
cobas® CHIKV/DENV
HSV-2 IgG Toxo IgG av.
for retesting system for Syphilis

• Short turnaround times, automation
and uninterrupted workflow generate
standardizing blood Bloodscreening assays
Product under development
Additional serology assays
time savings bank workflow

Solution components
Technologies that support timely and reliable release of safe blood supply
Serology Nucleic Acid Testing Pre-analytics & IT
cobas e 411 cobas 6000 cobas 6800/8800 cobas cobas cobas CCM
p 312 p 512 p 612
cobas IT solutions
cobas infinity blood safety
cobas IT middleware
cobas 8000 cobas s 201
Please contact your local Roche representative for detailed information.
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Point-of-care testing
Point of Care The goal of Point of Care from Roche is to
help both healthcare professionals and
While the responsibility for providing the
service is in the hands of professionals, we
CoaguChek patients achieve improved clinical and

health-economic outcomes, by delivering
also provide IT tools to be able to control
all aspects of testing to ensure quality
Anticoagulation
robust, connected, easy to use point-of- patient care:
care solutions outside the central lab, pro- • Provide accurate and timely analyses and
viding immediate results and thus allowing match them to the right patient
Glucose treatment decisions to be made more

quickly – inside or outside the hospital.
• Ensure that operators are competent in
the use of the system
Accu-Chek Point of Care delivers those solutions meet-

• Provide reports that are useful to the
clinician treating the patient
POC IT ing the clinical need for quick and accurate

test results delivered where needed, when
• Document testing and QC for audit
purposes
cobas needed; on the device, in the electronic

healthcare record on a patient/ward monitor, For coagulation patient self-monitoring
Cardiovascular to the clinician on the move and directly to

the patient.
we also provide solutions for remote
support and monitoring.
Diabetes For more information please
Dyslipidemia visit www.cobas.com

and www.CoaguChek.com
Critical care
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Overview of point-of-care
diagnostic tests www.cobas.com
Reflotron® Plus and

TROP T sensitive
CoaguChek® Pro
TROP T sensitive
CoaguChek® Pro
Reflotron® sprint
Reflotron® sprint
Accutrend® Plus
Accutrend® Plus
CoaguChek® XS
CoaguChek® XS
cobas b 123*
cobas b 221*
cobas b 123*
cobas b 221*
(visual strips)
(visual strips)
cobas b 101
cobas b 101
cobas h 232
cobas h 232
Urisys 1100®
Urisys 1100®
Accu-Chek®
Accu-Chek®
(visual strip)
(visual strip)
Inform II
Inform II
Combur
Combur
Anemia Myoglobin •
Bilirubin • • • • D-dimer •
Bilirubin neonatal • • HDL cholesterol (or HDL-C) • •
Hemoglobin total • • • • • LDL cholesterol (or LDL-C) • •
Hematocrit • • NT-proBNP •
Oxygen saturation (sO2) • • Coagulation
Blood gas D-dimer •
pH • • PT (INR/% Quick/sec.) • •
pCO2 • • aPTT •
pO2 • • Metabolic
Electrolytes Ca2+ • •
Ca2+ • • Cl- • •
Cl- • • Glucose • • • • • •
K+ • • HbA1c •
Na+ • • HDL cholesterol (or HDL-C) • •
CO-oximetry Ketone • •
tHb-COOX • • LDL cholesterol (or LDL-C) •
O2Hb • • Lactate • • • •
HHb • • Potassium • • •
COHb • • Sodium • •
MetHb • • Total cholesterol (or CHOL) • • •
sO2 COOX • • Triglycerides (or TG) • • •
Bilirubin neonatal • • Hepatology
Barmetric pressure (Baro) • • Alkaline phosphatase •
Cardiac Bilirubin •
Troponin T • • Creatine kinase •
CK-MB • GGT •
* In addition several calculated parameters are available.
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cobas® POC IT solution

Bringing it all together

cobas POC IT is responsible for collecting
TROP T sensitive
CoaguChek® Pro
Reflotron® sprint
Accutrend® Plus
CoaguChek® XS
results from POC analyzers that are
cobas b 123*
cobas b 221*
(visual strips)
cobas b 101
cobas h 232
Urisys 1100®
Accu-Chek®
(visual strip)
distributed across hospitals and primary
Inform II
Combur
care centres.
Hepatology The cobas POC IT solution brings all POC

GOT (AST) • information together to provide oversight
GPT (ALT) • via your POC program. Furthermore, it
Pancreatic amylase •
provides you with the insight required to
Urobilinogen •
Renal and urine ensure compliance and the long-range
Bilirubin • • • view to plan for improvements and expan- Your benefit
Creatinine • sion in the future. Coordinated user management
Erythrocytes (Hb) • • • A central point of control for all POC
Glucose • • • Roche is committed to assisting POC testing devices and users ensures result
Ketone • • Coordinators with powerful tools required security
Leukocytes • • to e ffectively manage POC testing, improve • Most efficient customizable online e-
Nitrite • •
workflows and meet accreditation and learning with automatic operator recerti-
pH • •
Protein • • regulatory requirements around the world. fication saves a significant amount of time
Specific gravity • •
Urea (BUN) • • Proven open connectivity to a wide menu Innovative functionality
Uric acid • of POC devices gives you the freedom of • Over a decade of collecting user input
Urobilinogen • • choice to grow your POC program. and workflows has resulted in a high level
of innovation that are firsts on the market
* In addition several calculated parameters are available. Open connectivity at its best
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www.cobas.com
such as true wireless communication and • Connects the full Roche POC portfolio cobas® POC IT solution
observed competency on-board POC including Accu-Chek Inform II, Coagu-
Laboratory
devices, as well as positive patient ID – Chek XS Plus and Pro, cobas h 232, information system
ensuring patient safety cobas b 101, Urysis 1100, cobas b 121
system, cobas b 123 POC system and
Local service and support cobas b 221 system.
• Quick and easy access to Roche service
personnel in your time zone and language cobas academy Roche hotline cobas IT 1000 cobas cobas b 123
cobas e-support bge link POC system
provides efficient turnaround time for • With cobas academy you can customize
your questions and ensures maximum eLearning courses and deploy training
uptime for the systems content on your intranet, and also allow
user re-certification automatically – the
Proven commitment system will also automatically lock out
• The cobas® POC IT solutions are proven users who are not certified until they have
to perform in over 1,450 systems in > 50 completed the required training.
countries with 70,000 connected devices.
Emergency Outpatient General Operating
• Including over > 50 Roche and non-Roche cobas bge link department department wards room
POC devices – with a long-term commit- • The cobas bge link software gives you
ment to enhancing value for patients and complete and easy remote management
POC coordinators missing period of POC blood gas analyzers, allowing you
to view and control device operations
Product characteristics simply and efficiently.
cobas IT 1000 application
• cobas IT 1000 application gives you com- cobas eServices
plete management of POC testing, includ- • Gives your local Roche experts remote
cobas academy e-learning
ing remote configuration and control of access, enabling them to quickly and
devices, user management and LIS/HIS efficiently answer your questions in your
interfacing from a single point of control time zone and language.
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cobas® infinity POC mobile

NEW
www.cobas.com
Always with you
cobas® infinity POC mobile is a mobile Automate Operator Management Product characteristics
app for iOS and Android devices, which The POCC or Nurse Educator can easily Usability has been at the core of the design
works in conjunction with cobas IT 1000. review and update operator training status, process and cobas® infinity POC mobile
It is designed to help POC Coordinators quickly identifying those operators has been independently rated for usability,
(POCCs) complete key tasks whilst on the go. with expired or soon to expire certificates. scoring extremely highly. The product has
been designed from the bottom up to be
Due to the nature of the testing that they Act on What’s Important easy to use from a mobile device.
support, a POCC does a lot of their work With cobas® infinity POC mobile, a POC
while “out and about” around hospital Coordinator can monitor overall performance cobas® infinity POC mobile enables the
locations. Some of their time is spent at of POC testing and spot any issues that need POCC to easily carryout key workflows
their desk, some walking around and to be dealt with quickly and easily. whilst on the move:
for many tasks, they need to find a PC in • Device replacement
order to access a desktop. • Device relocation
• Checking device status
This dictates how POC Coordinators work, • Adding a new operator
and limits productivity. cobas® infinity • Editing existing operator details
POC mobile empowers the POCC, freeing • Checking operator training status
them from their office and enabling them to: • Export a list of operators requiring training
save time managing devices, automate • Update operator training status
operator management and act on what’s
important. Technical requirements
• cobas® IT 1000 v2.04.01 or higher and
Your benefit networked mobile device
Save Time Managing Devices • iOS 7 or higher
The POCC can easily monitor device con- • Android 4.1 or higher
nectivity and QC status. Enabling them • Mobile device on hospital network
to quickly identify where they are needed • (VPN for remote connection)
for problem solving.
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cobas® bge link software

www.cobas.com
Central control of your Roche blood gas
and electrolyte analyzers
The cobas bge link software provides Your benefit Product characteristics
complete remote management and control Save time • Information on analyzer status, parameters,
of blood gas instruments from one work- • By not having to walk to each analyzer, reagents and reports in a clearly arranged
station. with continuous remote status monitoring layout
of your blood gas and electrolyte systems, • Management of quality controls and
This valuable tool allows the complete from the laboratory c alibration cycles
management of all cobas blood gas • Clear presentation of patient results
analyzers that are connected to a hospital Improve analyzer uptime measured with the blood gas and
network. The cobas bge link software • With effective remote troubleshooting electrolyte systems from Roche
can improve workflow efficiency, freeing and remote control of analyzer functions • Remote control of calibrations, cleaning
up valuable staff time and improving (e.g. calibrations, QC, cleaning cycles, cycles and test functions
service to clinicians in critical care settings. test functions) • Initiation of quality control on the blood
gas and electrolyte systems from Roche
Increase confidence and security (AutoQC®), can be initiated from the
• With remote monitoring of analyzer laboratory
performance and quality while offering • Levy-Jennings overview of QC history
a clear and comprehensive audit trail and trends
• Extensive data management possible
through integration into cobas® POC IT
solution
Roche
Service Center
cobas b 221 system cobas b 123 POC system

e.g. intensive care unit e.g. neonatal ICU
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cobas b 221 system

www.cobas.com
Convenience for your critical care testing
Blood gas analysis is considered the most Your benefit

important tool for diagnosis in critically Fast diagnosis
ill patients. Analyzers should deliver rapid • Results in less than 2 minutes to support
and reliable results, be easy to handle and timely clinical decision making
require little maintenance. Our cobas b 221
system offers these features – and a flexible Flexibility of testing
configuration which can meet your specific • Comprehensive parameter menu to meet
requirements for critical care testing in high varying department needs
throughput departments.
Confidence in result quality
• Lab-quality results where and when Product characteristics • Trending acid-base maps to support
you need them • Throughput: up to 50 samples/hour clinical decisions
• Time to result: less than 2 minutes with • Reagent tracking
Improved uptime whole-blood sampling • Customizable features include a user-
• Long-life, maintenance-free electrodes • Optional module for automatic quality control definable display and two types of sample
and minimal preventative maintenance • Three different parameter combinations application
(see table below) including glucose, • Connectable to network via the cobas®
lactate, urea and bilirubin bge link software for remote control
• Durable, low-maintenance sensors and to the cobas POC IT solution for
• Easy-to-use touchscreen and intuitive comprehensive data management
user interface
cobas b 221 system Versions

2 4 6
pH/blood gas (PO2, PCO2, pH)/CO-oximetry   
Electrolytes (Na+, K+, Ca2+, Cl-)/hematocrit  
Metabolites Glu/Lac 
Metabolites Glu/Lac/Urea (BUN) 
Bilirubin   
cobas b 221 system
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cobas b 123 POC system

www.cobas.com
Allowing you to focus on patient critical care
The cobas b 123 POC system is a mobile, Your benefit Product characteristics
cartridge-based, critical care analyzer Easy to use • Throughput: 30 samples/hour
designed for POC testing. With flexible • Intuitive graphical user interface, touch- • Integration of clot prevention features to
configurations and a throughput of up to screen and graphically guided instruc- ensure patient care without interruption
30 samples per hour, the cobas b 123 POC tions allow handling steps to be learned and cost-efficient operation
system can easily be customized to the in minutes and simplify the training of • Optional mobile cart, battery operation
clinical needs of the ICU, ER, NICU, OR*, POC users and wireless connectivity enables
dialysis units or the laboratory. instrument to be operated wherever it
Safe is needed
The operator-friendly system offers easy • Access control, clot prevention, data • Variety of sample types: whole
handling and requires no preventative management including QC, remote blood,dialysis solution, QC solutions • Trending acid-base maps to support
maintenance, reducing analyzer downtime. control to increase analyzer uptime (both aqueous and blood-based) clinical decisions
• Connection to cobas® bge link software • Fluid pack – sizes 200, 400 or 700 samples
Rapid results and cobas POC IT solution
• Near-patient, whole-blood sampling pro- • Automated user management through
vides results in only 2 minutes to support cobas e-learning
timely clinical decision making
Flexibility and scalability cobas b 123 POC system Versions
• Allows clinically relevant and cost-efficient 1 2 3 4

pH/blood gas (pO2, pCO2, pH)    
POC testing including quality control
Electrolytes (Na+, K+, Ca2+, Cl-)/Hematocrit    
Metabolites Glu/Lac    
Bilirubin  
Co-oximetry (tHb, O2Hb, HHb, COHb, MetHb, SO2)  
Auto QC  
Plus an extensive range of calculated parameters.
* Intensive care unit, emergency room, neonatal

cobas b 123 POC system i ntensive care unit, operating room.
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Accu-Chek ® Inform II solution

Safe for patients. Simple for professionals.
Efficient for hospitals.
Roche offers a comprehensive solution Your benefit Product characteristics

for professional testing of blood glucose Assured patient safety Assured patient safety
in hospitals. Blood glucose testing is • The Accu-Chek® Inform II solution • Infection control with an integrated
an important standard of medical care brings laboratory safety standards product design of the meter, the
in hospitals. to bedside glucose testing and strips and the lancets
ensures safety for patients and users • Improved clinical decision making
The Accu-Chek® Inform II system and with reports of actionable data per
the cobas infinity POC IT solutions together Premium quality of results user needs
support Point of Care coordinators, • Enables POC testing to meet the
physicians, nurses, IT experts and infection highest lab standards when non- Premium quality of results
control managers to better manage laboratory experts conduct glucose • Lab standards met with lot-by-lot
their complex working tasks. testing calibration and traceability to NIST
• High accuracy with proven
Automated re-certification repeatability and reproducibility,
• Of device users and many other 190+ interferences tested
automated job tasks centralize the
decentralized Point of Care traffic Automated re-certification
efficiently • POC workflow automation
with automated user re-certification
By your side support and notifications
• Is a given for continued success • Access and action of test results,
with your hospital blood glucose operator performance, and system
solution – provided by the market issues on the go
leader in hospital glucose testing
By your side support
• More than 20 years of experience
in service and support, with
over 150,000 meter placements in
the world and a broad expertise
Accu-Chek Inform II system in system installation, analysis,
consultancy and user training
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cobas h 232 POC system

www.cobas.com
Facilitate your clinical decisions with rapid results
Portable and easy-to-use, the cobas h 232 Your benefit Available parameters
system helps frontline healthcare providers Fast and reliable patient stratification
Test Measuring range Time to results Clinical utility
to quickly make a confident decision whether • Flexible: Suitable for use in pre-hospital
Troponin T 40 – 2,000 ng/L 12 min Identification of patients with suspected acute
to admit, discharge or transfer a patient settings and ER for early triage of patients myocardial infarction at high risk of mortality
presenting with acute chest pain, dyspnea • Quickly ready-to-use: Requires no sample NT-proBNP 60 – 9,000 pg/mL 12 min Aid in diagnosis of patients with suspected heart
or other symptoms suggestive of acute preparation or lengthy setup procedures failure, in monitoring of patients with compensated
left ventricular dysfunction and in risk stratification
cardiovascular disease. • Reliable: Results comparable to Roche of patients with acute coronary syndromes
laboratory methods available in maximum CK-MB 1.0 – 40 ng/mL 12 min Diagnosis of acute coronary syndrome and myocardial
infarction, assessment of re-infarction
Thanks to its compact design, the cobas h 12 minutes
D-Dimer 0.1 – 4.0 µg/mL 8 min Exclusion of deep vein thrombosis and pulmonary
232 can easily be deployed near the POC embolism
patient where space is tight and mobile use Safety Myoglobin 30 – 700 ng/mL 8 min Early marker of myocardial damage to assist
in diagnosis of acute coronary syndrome and
is required, such as ambulances, general • Operator ID entry and lockout to ensure myocardial infarction
practitioners office, emergency room (ER), use by authorized staff
or a designated lab area. • Patient and user ID to ensure correct
documentation of test results
• Quality control lockout
Control and traceability

• Connection to the cobas® POC IT
solution allows extension of the testing
network and ensures control of
operators and quality assurance from the
central laboratory
• Automatic recertification of operators
through cobas academy to ensure use by
trained operators only
cobas h 232 POC system Optional integrated bar-
code scanner and external
printer for greater safety
and record keeping
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Roche CARDIAC® Trop T Sensitive test

www.cobas.com
Visual test for the rapid diagnosis
of myocardial infarction
Many patients seek medical attention only Your benefit Product characteristics
hours or even days after the onset of chest Highly versatile • Qualitative detection of troponin in
pain, especially on weekends. With the • Suitable for use in different clinical anticoagulated (EDTA or heparin) venous
Roche CARDIAC Trop T Sensitive test you settings, e.g. emergency room, GP office whole blood
can make a diagnosis even several days or ambulance • Reaction time: 15 min.
(up to 10 – 14 days) after myocardial dam- • Positive result from a threshold (cut-off)
age occurs. Fast results of 100 ng/L
• Reliable yes/no result in 15 – 20 min. • Storage at 2 – 8° C (refrigerator)
The Trop T Sensitive is a visual troponin T • Test can be used immediately after
test. Since it requires no system it can be Easy handling and portability removal from the refrigerator
easily deployed in rural areas near the point • Simple application that can be used • Storage for 1 week at room temperature
of patient care, at the bedside, in triage anywhere (15 – 25° C)
bays, emergency service areas, ambulances • No sample preparation • Roche CARDIAC Trop T Sensitive is
or a designated lab area. The Trop T Sensi- • Device independent available in 5 and 10 pack sizes
tive test is designed for qualitative deter
mination of cardiac troponin T in the blood Reliable qualitative measurements
and elevated levels indicate acute mycardial • Proven test strip technology
infarction.
Cost-effective
Results from a large prospective clinical trial* • Requires no external measurement system
in Denmark indicate that implementation of • Requires no special training
qualitative pre-hospital troponin T testing
in the ambulance vehicle by paramedics is On the spot rule-in acute myocardial
feasible in most patients, including non-ST infarction
segment elevation myocardial infarction • Specific cardiac marker – A positive result
(NSTEMI) patients whose condition is not indicates myocardial damage
detected by the classical electrocardiogram. • Even if characteristic ECG changes are
missing, a positive Roche CARDIAC Trop T
Sensitive test with a non-ST-elevation * Sørensen, J.T., Terkelsen, C.J., Steengaard, C.,… Prehospital troponin T testing
myocardial infarction (NSTEMI) can aid in the diagnosis and triage of patients with suspected acute myocardial infarction.
the treatment decision Am J Cardiol. 2011 May 15;107(10):1436-40.
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CoaguChek® XS system
www.CoaguChek.com
Coagulation self-testing made easy
The CoaguChek® XS system is a convenient, Your benefit Product characteristics

portable and user-friendly instrument for Fast, reliable results • Test principle: Electrochemical deter
monitoring oral anticoagulation therapy. • Accurate PT/INR results in one minute mination of the Prothrombin time (PT)
It determines the INR value (International • Built-in quality control checks every strip after activation
Normalized Ratio) from a drop of capillary automatically of coagulation with human recombinant
whole blood – simple, precise and reliable. • Lab-equivalent accuracy precision1 thromboplastin
• User interface: Icon-based LCD display;
The CoaguChek XS system is ready for use Simple fingerstick test on/off, mem and set buttons
anywhere at any time. Patients can use • Most patients prefer having a small drop • Memory capacity: 300 test results with
it for self-monitoring at home or while on of blood (just 8 μL) taken from a finger- date and time
vacation. stick to having blood drawn from a vein3 • Sample types: Fresh capillary or
anticoagulant-free venous whole blood
Improved patient outcomes • Easy blood application: top- or side
• Frequent testing allows side effects to be dosing
minimized and increases the time spent • Measuring range:
within the therapeutic range 2 INR: 0.8 – 8.0
%Quick: 120 – 5
Seconds: 9.6 – 96
• Data transfer: Infrared interface
1 Kitchen, D.P., Munroe, S., Kitchen, S., Jennings, I., Woods, T.A.L., Walker, I.D. (2008). Results from the first
year of an external quality assessment programme for the users of CoaguChek XS and CoaguChek XS
Plus for monitoring INRs. British Journal of Haematology, Volume 141 Supplement 1: P188.
2 Heneghan, et. al (2006). Lancet, 367; 404-411.
3 Woods, K., Douketis, J.D., Schnurr, T., Kinnon, K., Powers, P. et al. (2004). Patient preferences for
capillary vs. venous INR determination in an anticoagulation clinic: a randomized controlled trial.
Thromb Res 114(3), 161-165.
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CoaguChek ® Pro II system

www.CoaguChek.com
Delivering life-saving care with
immediately actionable coagulation
results at ALL points of care
CoaguChek® Pro II is the clinically vital point- Your benefit Product characteristics
of-care coagulation testing device. In Achieve greater insight into patients’ • Test principle: Electrochemical deter
addition to monitoring oral anticoagulation coagulation status with the ability to measure mination of the PT and aPTT time after
therapy, the Prothrombin Time (PT) and aPTT and PT, and gain a clinically vital activation of coagulation cascade
activated Partial Prothrombin Time (aPTT) tool in coagulation care. • Approved for use with capillary, venous,
tests will help in the determination of and arterial whole blood
factor deficiencies and other coagulopathies Enhanced connectivity through wireless • User interface: large TFT color touchscreen;
in several point-of-care locations. technology and a unique QR code screen icons allow intuitive operation
feature can result in fewer errors, increased • Memory capacity: 2,000 test results
The enhanced connectivity options allow safety, and a streamlined workflow. with date and time and 4,000+ patient
for immediate access to patients’ data via and operator ID lists
their electronic health records because Ease of implementation with little training – Integrated 2D barcode reader for
wireless technology ensures fast, accurate and ease of use with results automatically entering user/patient ID and lot
transmission so that workflow will be more transmitted to patients’ electronic records numbers of controls
streamlined and results will be available for facilitate the use of CoaguChek Pro II in more • Automatic code chip identification to
immediate treatment decisions. places for more patients. match lot-specific information with test
strips in use
Convenient, portable and user-friendly, – 2 level Liquid control available for
the CoaguChek Pro II delivers precise and dedicated QC requirements
reliable results from just a drop of blood. • Enhanced data management capabilities:
– WLAN-enabled measuring device
The CoaguChek Pro II succeeds the connecting to industry standard POCT1-A
CoaguChek XS Plus and CoaguChek XS Pro or Roche internal protocol– complete
systems and is intended for professional use. documentation of results
– Unique QR Code feature allows effortless,
real-time transmission of patient data
from any location to the customer’s data
management solution without the need
for POCT1-A communication capability
CoaguChek Pro II
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Accutrend® Plus system

www.cobas.com
Screening for cardiovascular risk factors
The Accutrend Plus system is a flexible, Your benefit Product characteristics

hand-held point-of-care device for the key On the spot results • Convenient determination of cholesterol,
parameters used to detect cardiovascular • Point-of-care lipid testing can substantially triglycerides, glucose and lactate using
disease: improve identification and management of capillary blood
• Total cholesterol dyslipidemic patients in primary care • Positive control strip and parameter
• Triglycerides • Make immediate recommendations recognition are used for calibration
• Glucose and lactate regarding lifestyle or treatment, leading to • Test strips can be stored at room
improved patient compliance and loyalty temperature
This cost-effective, all-in-one device • Can store up to 100 different measure-
provides rapid, yet accurate results. Safety and reassurance ments with date, time and flags
• Built-in automatic performance testing • Great precision and accuracy across
and meter self-testing for reliable results the measuring range
Ease of use
• Simplicity makes device ideal for testing
in the physician office or in hospital s ettings
Test Measuring ranges Measuring Sample material Sample Operating

time volumes conditions
mg/dL mmol/L
Glucose 20 – 600 1.1 – 33.3 12 sec • Fresh capillary blood 15 – 50 µL 18° – 35° C
Cholesterol 150 – 300 3.88 – 7.76 180 sec • Fresh capillary blood 15 – 40 µL 18° – 35° C
• Use of heparin-coated
pipettes possible
Triglycerides 70 – 600 0.80–6.86 max. 174 sec • F resh capillary blood 10 – 40 µL 18° – 30° C
•U se of heparin-coated
pipettes possible
Lactate 0.8 – 22 mmol/L 60 sec • F resh capillary blood 15 – 50 µL 5° – 35° or 15° – 35° C
•U se of heparin-coated depending on concent-
pipettes possible ration of analyte
Accutrend Plus system
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Reflotron® Plus system and

Reflotron® Sprint systems www.cobas.com
Flexible testing to support your clinical decisions
The Reflotron Plus system is a single-test Your benefit Product characteristics • Sample volume: 30 µL
clinical chemistry system which allows the Reliability • Throughput of Reflotron® Sprint: • Time-to-result: only 2 – 3 min.
measurement of 17 parameters from whole • Test results, correlating well with stan- Up to approx. 60 tests/hour (depends on parameter)
blood, plasma or serum – including liver dardized laboratory methods and validated • Throughput of Reflotron Plus: • Integrated printer:
and pancreas enzymes, metabolites, blood in a number of clinical studies even from Up to approx. 25 tests/hour Immediate documentation of results
lipids, hemoglobin and potassium. capillary samples • Sample material: whole blood • Barcode reader and/or keyboard
• No storage concerns due to excellent test (capillary and venous) plasma or serum for patient and sample ID input
Immediate and reliable test results ensure strip stability
quick performance and verification of the • Little waste and almost no maintenance Covering a wide range of daily routine and emergency testing
diagnosis without delay.
Faster clinical decision making Muscle diseases Anemia
The system is suitable for primary care • Quick time to result
settings, as a back-up system in hospitals • No reagent preparation
and private labs, at screening sites and for Lipid metabolism disorders Bone diseases
health check-ups.
Liver diseases Renal diseases
Gout Diabetes / Pancreatitis
Reflotron Plus system Reflotron Sprint system
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cobas b 101 system

www.cobas.com
Managing diabetes and dyslipidemia
at the point of “need”
The cobas b 101 system is an IVD Your benefit Product characteristics

test system offering HbA1c and a complete Guideline compliant performance • User-friendly with a large touchscreen,
lipid profile tests at the Point of Care. • cobas b 101 system complies with all full keyboard, and multiple languages
Fresh capillary blood, K2 or K3-EDTA venous relevant standards and methods (IFCC, support
whole blood or plasma * can be used. DCCT/NGSP and NCEP)1 • Robust, maintenance- and calibration-
free with a wide operating temperature
The system delivers fast and reliable results Easy and safe operation and humidity range
and is intended for professional use in • Direct blood application from a single • Connection to the cobas POC IT solution
a clinical laboratory setting or at point-of- finger stick with small volume • External printer or barcode scanner allow
care locations. • No calibration needed, maintenance an improved workflow and documentation
and service-free, graphical guidance • Data download to USB stick or direct to
for simplified use PC are possible
Fast turnaround time Disc features

• An intuitive 15 min. workflow from • Direct sample application (no capillaries,
patient preparation to results display tubes or pipettes are needed) and
of both HbA1c and lipid panel requires only very small sample volumes
(2 µL for HbA1c, 19 µL for lipids) Parameters and measuring range
• Discs are color-coded and clearly labelled in the therapeutically important range
IFCC: International Federation of Clinical Chemistry
to support correct use. Flap for high • HbA1c disc:
DCCT: Diabetes Control and Complications Trial
NCEP: National Cholesterol Education Program
operator safety – IFCC: 20 – 130 mmol/mol
NGSP: National Glycohemoglobin Standardization • Discs can be stored for more than – NGSP: 4 – 14 %
Program 13 months from production at room – eAG **
temperature (2 – 30ºC) • Lipid disc:
* P lasma for lipid panel only.
– CHOL: 50 – 500 mg/dL
** C alculated
– TG: 45 – 650 mg/dL
1 Roche internal verification data – HDL: 15 – 100 mg/dL
cobas b 101 system (multi-center evaluation). – LDL, Non-HDL and TC/HDL **
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Tissue diagnostics
VENTANA Ventana Medical Systems, Inc., a member
of the Roche Group, is one of the world’s
In addition, Ventana offers premier workflow
solutions specially designed to improve
Innovative diagnostic instruments leading cancer diagnostic companies and

is an innovator of tissue-based tests
laboratory efficiency and protect p
safety.
atient
High-value assays
that enable the delivery of Personalized
Healthcare to cancer patients. Recognizing the world’s increasing medical
needs, Ventana focuses on accelerating
Digital pathology and workflow The founder of Ventana, Thomas Grogan,

M.D., Professor of Pathology, University of
the discovery and development of new
prognostic and predictive cancer tests
Companion diagnostics
Arizona, established the concept of a single, that help enable Personalized Healthcare.
complete report covering all aspects of These tests allow pathologists to analyze
a patient’s case, which helps to improve patient samples at the molecular, cellular
Consultative services survivability. and tissue level to help determine the best
course of therapy for individual patients.
Ventana is passionate about its mission to
improve the lives of all patients afflicted For more information please
with cancer by developing and delivering visit www.ventana.com
medical diagnostic systems and tissue-
based cancer tests that are shaping the
future of healthcare. VENTANA products
provide healthcare professionals with a
comprehensive solution for the critical steps
involved in the analysis of tissue samples.
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Tissue diagnostics
Leading future innovation
Workflow
Sample preparation H&E staining* Special stains IHC/ISH staining Digital pathology
histology
Tissue processing Morphology Protein/DNA tests Scanner and software
(IHC/ISH)
6 6
Method
e. g., HER2(4B5) IHC, HER2 Dual ISH

VENTANA HE 600 BenchMark BenchMark series iScan scanners and
system Special Stains Virtuoso software
1 2 3 4 5
Roche products VANTAGE workflow management software
1 VANTAGE software 3 BenchMark Special Stains instrument • Systems with different capacity available • Industry-leading Companion Algorithm
• Workflow solution from sample preparation • Fully automated special stains from to fit small to large laboratories image analysis solution delivers consistent
to statistics monitoring baking to staining • Open systems for antibodies and objective results, time after time
• Tracking of both samples and monitoring of • Capacity up to 20 slides per run
the lab activity to help ensure quality • Individual heater pads 5 Digital pathology 6 Reagents
• Workflow consulting to optimise processes • Pre-packed complete detection kits • Comprehensive digital pathology • H&E, IHC *, ISH *, SpSt *
solution — from scanning and image • More than 250 antibodies
2 VENTANA HE 600 system 4 enchMark IHC/ISH automated
B viewing to customized reporting • Ready-to-use and barcoded reagents
• Individual slide staining technology for H&E staining series • VENTANA iScan HT and iScan Coreo
• Fully automated H&E staining from drying • Fully automated IHC * and ISH * systems, scanners — combine unprecedented
to glass coverslipping driven by easy-to-use barcoded slides flexibility, throughput and reliability
• Elimination of xylene and alcohol from the and reagents • VIRTUOSO image and workflow
H&E process management software — designed for
clinical laboratory use
* H &E = Hematoxylin and Eosin, ISH = In situ Hybridisation, IHC= Immunohistochemistry, SpSt = Special stains
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VENTANA HE 600 system

NEW
Master the art and science of H&E staining
Histology laboratories face a critical chal- Your benefit Product characteristics

lenge — even in today’s high-tech world. Create seamless workflow and • Throughput: 180 – 200 slides per hour • LIS connectivity through the VENTANA
H&E slide preparation continues to be a efficiency at mid stain protocols workflow solutions
touch point and wait point intensive process. • Provides optimal efficiency by reducing • System integration from drying through • CareGiver remote support is an automated
The VENTANA HE 600 system is the newest touch points and wait points in the H&E glass coverslipping remote monitoring and diagnostics solu-
innovation from Roche Diagnostics that process by consolidating ovens, stainers, • Easily customizable staining protocols tion that enables continuous monitoring
enables high levels of efficiency, stain and coverslipping into a single system for unmatched staining flexibility and r emote service for VENTANA HE 600
quality, and improved safety, all while • Frees technicians to focus on value added • Enables over 400 customized protocols system
providing unprecedented flexibility in the activities to optimize staining
pathology laboratory – creating better • Barcode tracking provides full chain of
results for you, your laboratory and your Make every patients slide custody
patients. a masterpiece
• Individual slide staining provides
unparalleled levels of stain consistency
and reproducibly to ensure your first
slide of the day has the same level of
quality as your last
• Ready-to-use reagents that are certified
and tested for quality to provide consis-
tent, high-quality stains
Improved patient and technologist

safety
• Individual slide staining with fresh
reagents on every slide mitigates
tissue cross-contamination and reagent
carryover in the H&E process
• Eliminates xylene and alcohol for the H&E
process
VENTANA HE 600 system
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BenchMark Special Stains

Automated slide stainer
The Ventana BenchMark Special Stains Your benefit Reduced risk

automated slide stainer brings complete Superior special stains workflow • Individual slide staining mitigates risk for
baking through staining to the histology efficiency cross contamination
laboratory for special stains, so your lab • Eliminates manual processes and temper- • Ready to use reagents reduces technician
can consistently deliver exceptional quality. ature dependencies with automated depar- risk due to exposure to harmful chemicals
Productivity features such as random batch affinization and independent slide heating
access, as well as full process integration, Product features/specifications
including deparaffinization through staining, Consistent quality • Workflow: Fully automated baking, depar-
improves turnaround time and optimizes • Enhanced protocol flexibility with expanded affinization and staining of special stains
workflow. user selectable options in order to meet • Slide carousel: 1– 20 slides with indepen-
pathologists’ preferences dent temperature control for each position
Reduce manual processes and improve • Individual slide staining using quality- • Reagent carousel: 25 reagent positions
your capabilities by allocating your skilled controlled, ready to use reagents delivers • Slides: 25 x 75 mm, 1 x 3” or 26 x 76 mm
laboratory professionals to higher value consistent, high quality results positively charged
contributions. • Bulk fluids: Up to 4 bulk fluids in 3 to
6 liter on-board containers
• Modularity: 1– 8 BenchMark Special
Stains and BenchMark ULTRA systems
may be controlled from one host PC
Special Stains menu:
Special Stains reagents • AFB III • Iron
The new BenchMark Special Stains system • Alcian Blue • Jones Light Green
brings reproducible, high quality staining • Alcian Blue for PAS • Jones Hematoxylin
capabilities by providing ready-to-use, • Alcian Yellow • Light Green for PAS
quality controlled reagents. • Congo Red • Mucicarmine
• Diastase • PAS
• Elastic • Reticulum II
• Giemsa • Steiner II
• GMS II • Trichrome Blue
• Gram • Green for Trichrome
214 | 215 BenchMark Special Stains

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BenchMark IHC/ISH platform

Automated slide staining systems
Minimize diagnostic lead time, maintain Your benefit BenchMark system features
consistent high quality and streamline Fully automated Unique and innovative technology for
workflow in the histology laboratory with • Standardised IHC and ISH staining best patient care by kinetically optimized
the BenchMark IHC/ISH instruments. • Dual and triple stains reaction
• Individual heater pads
The BenchMark GX, BenchMark XT and Flexibility • Liquid coverslip controls evaporation and
BenchMark ULTRA instruments automate • Select from over 250 available Ventana integrity
all slide preparation steps of immunohisto- antibodies, or use your own a ntibodies • Full slide coverage with 100 μL
chemistry (IHC), fluorescent IHC, in situ • Independent and simultaneous processing • Air vortex mixing
hybridisation (ISH) and Dual Color Silver • Immediately process STAT and late-
tests. They have the flexibility you need to Optimal quality BenchMark GX system arriving samples
expand your test menu, process more • Independent protocols for each slide • 20 slide positions • Simultaneous IHC/ISH testing on a single
slides and improve your turnaround time. • Barcoded slides and reagents for case • 25 reagent positions platform
identification and traceability • Low to medium throughput
• Complete batching IHC and LIS or VANTAGE software connection
Workflow ISH diagnosis system • Connect multiple systems with a
• Higher throughput and faster single computer or add a new system
turnaround times BenchMark XT system to existing ones
• Increased laboratory productivity and • 30 slide positions • Share reagents and protocols across
reduced rework • 35 reagent positions instruments through Central Management
• Medium to high throughput software
• Independent or simultaneous processing • Download patient accession and test
of IHC and ISH steps information from LIS to slide staining
system to mitigate data entry errors
BenchMark ULTRA system
• 30 slide positions
• 35 reagent positions
• Flexibility to add/remove slides without
impacting workflow
• Ability to add or remove reagents without
BenchMark GX system BenchMark XT system BenchMark ULTRA system interrupting cases in process
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IHC detection
Meet your needs and everything beyond
IHC/ISH detection Your benefit

Ventana offers a comprehensive menu of OptiView DAB IHC detection
optimized detection systems for use with
our Ventana BenchMark IHC/ISH automated Increased sensitivity
slide stainers, allowing for the identification By increasing the numbers of HRP enzymes
of targets by IHC and ISH. at each primary antibody site, OptiView
provides unparalleled signal intensity,
IHC detection offerings empowering you to achieve the level of
Choose from a comprehensive menu of intensity you desire for even the low-
detection chemistries (biotin and biotin-free expressing antigens.
based systems) and stains (DAB and Red) Ventana p63 stained with OptiView DAB IHC d etection. Cyclin D1 (SP4) on mantle cell lymphoma
for high-quality IHC results: Enhance stain quality with OptiView DAB IHC Detection Kit.
• iVIEW DAB Detection Kit The OptiView DAB IHC Detection Kit offers Our synthetic, non-endogenous hapten
(biotin streptavidin) advancements in detection technology, system virtually eliminates background,
• ultraView Universal DAB Detection Kit using a proprietary non-endogenous, even as signal intensity increases, to create
• ultraView Universal Alkaline Phosphatase biotin-free hapten technology that allows the perfect view.
Red Detection for exceptional range in sensitivity with
• OptiView DAB IHC Detection Kit extremely low background. Using Ventana Customize intensity
OptiView detection software with the Unique chemistry and flexible software
ISH detection offerings BenchMark IHC/ISH platform provides enable greater control to meet preferred
Our comprehensive menu of indirect, the ability to optimise testing to achieve a staining intensity.
biotin-free detection systems and stains desired level of sensitivity and improved
(Blue, Silver and Red) provides the options turnaround times, with flexible protocols Improve turnaround time
you need for high-quality ISH results: and workflow enhancements. Amazing sensitivity and software flexibility
• ISH iVIEW Blue Plus Detection Kit allows you to reduce turnaround time by
• ultraView SISH Detection Kit 30 minutes or more for most assays.
• ultraView SISH DNP Detection Kit
• ultraView Red ISH Detection Kit
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Primary antibodies
Over 250 ready-to-use clinical reagents, optimized
for use on Ventana staining platforms
Ready-to-use antibodies
Lambda, FITC bcl-2 (SP66) CD68 (KP-1), CONFIRM
Ventana antibodies, including a world-class novel antibodies still in the research phase. HHV-8 (Human Herpes Virus Type 8) bcl-2 (124), CONFIRM CD71 (MRQ-48)
breast panel, cover the pathology world’s Staining analysis is facilitated by advanced (13B10) bcl-6 (GI191E/A8) CD79a (SP18), CONFIRM
diagnostic requests. Ventana a ntibodies antibody performance and multiple detection IgA (Immunoglobulin A) BOB.1 (SP92) CD99 (O13), CONFIRM
include IVD/CE-IVD antibodies, as well as technologies. IgA (Immunoglobulin A), FITC c-Myc (Y69) CD138 (Syndecan-1) (B-A38)
IgG (Immunoglobulin G) CD1a (EP3622) Cyclin D1 (SP4-R)
IgG (Immunoglobulin G), FITC CD2 (MRQ-11) Fascin (55k-2)
Breast Cervical a-1-Antichymotrypsin (ACT) IgM (Immunoglobulin M) CD3 (2GV6), CONFIRM FoxP1 (SP133)
Actin, Smooth Muscle (1A4) CINtec® PLUS p16/Ki-67 dual stain a-1-Antitrypsin (AAT) IgM (Immunoglobulin M), FITC CD4 (SP35), CONFIRM Galectin-3 (9C4)
Beta-catenin (I4) (Cytology) (E6H4™ and 274-11 AC3) CEA (CEA31) Macrophage (HAM-56) CD5 (SP19), CONFIRM Glycophorin A (GA-R2)
Calponin-1 (EP798Y) CINtec® p16 Histology (E6H4) Carcinoembryonic Antigen (CEA) MART-1/melan A (A103), CONFIRM CD7 (SP94) Granzyme B
Cytokeratin 14 (SP53) Colorectal and Gastrointestinal (TF3H8-1)
Melanoma Associated Antigen CD8 (SP57) Hemoglobin A (SP212)
Cytokeratin 5/6 (D5/16B4) Beta-catenin (14) CD2 (MRQ-11) (KBA.62) CD10 (SP67), VENTANA HGAL (MRQ-49)
E-cadherin (36), CONFIRM BRAF-V600E (VE1) CD3 (2GV6), CONFIRM Melanoma Associated Antigen (PNL2) CD13 (SP187) IgA (Immunoglobulin A)
E-cadherin (EP700Y) c-KIT (9.7), PATHWAY CD31 (JC70) Melanoma Triple Cocktail (A103, CD14 (EPR3653) IgD (Immunoglobulin D)
Estrogen Receptor (ER) (SP1), Cadherin 17 (SP183) CD34 (QBEnd/10), CONFIRM HMB45, T311) CD15 (MMA), CONFIRM IgG (Immunoglobulin G)
CONFIRM CEA (TF3H8-1) CD63 (NKI/C3) Melanosome (HMB45), CONFIRM CD16 (SP175) IgM (Immunoglobulin M)
FoxA1 (2F-83) CEA (CEA31) Cytokeratin (34bE12), CONFIRM MITF (C5/D5), CONFIRM CD20 (L26), CONFIRM Kappa, CONFIRM
GATA3 (L50-823) CDX-2 (EPR2764Y) Cytokeratin (AE1), CONFIRM Neurofilament (2F11) CD22 (SP104) Lambda, CONFIRM
GCDFP-15 (EP1582Y) COX-2 (SP21) Cytokeratin 8 and 18 (B22.1 and B23.1), p53 (DO-7), CONFIRM CD23 (SP23), CONFIRM LMO2 (1A9-1), CONFIRM
HER2 Dual ISH DNA Probe Cocktail Cytokeratin 7 (SP52), CONFIRM CONFIRM
p53 (Bp53-11) CD25 (4C9) LMO2 (SP51)
assay, INFORM Cytokeratin 19 (A53-B/A2.26) Desmin (DE-R-11), CONFIRM Podoplanin (D2-40) CD30 (Ber-H2) Lysozyme
HER-2/neu (4B5), PATHWAY Cytokeratin 20 (SP33), CONFIRM EMA (Epithelial Membrane Antigen) S100 (4C4.9), CONFIRM CD31 (JC70) MUM1 (MRQ-43)
HER-2/neu (4B5), VENTANA DOG1 (SP31) (E29), CONFIRM
S100 (Polyclonal), CONFIRM CD34 (QBEnd/10), CONFIRM Myeloperoxidase
IGF-1R (G11) Glutamine Synthetase (GS-6) Ep-CAM (Epithelial Specific Antigen) SOX-10 (SP267) CD38 (SP149) Oct-2 (MRQ-2)
Ki-67 (30-9), CONFIRM Helicobacter pylori (SP48), VENTANA (Ber-EP4)
Synaptophysin (MRQ-40) CD43 (L60) PAX5 (SP34), CONFIRM
p120 (98) MLH-1 (M1) Factor VIII Related Antigen Synaptophysin (SP11), CONFIRM CD45 (LCA) (2B11 and PD7/26) PD-1 (NAT-105)
p53 (DO-7), CONFIRM MSH2 (G219-1129) Factor XIIIa (AC-1A1) Tryptase (G3) CD45 (LCA) (RP2/18), CONFIRM SOX-11 (MRQ-58)
p63 (4A4) MSH6 (44), CONFIRM Factor XIIIa (EP3372) Tyrosinase (T311), CONFIRM CD45R (MB1) Spectrin (RBC2/3D5)
Progesterone Receptor (PR) MUC1 (H23) C1q, FITC Vimentin (V9), CONFIRM CD45RO (UCHL-1), CONFIRM T-bet (MRQ-46)
(1E2),CONFIRM MUC2 (MRQ-18) C3, FITC Vimentin (Vim 3B4), CONFIRM CD56 (123C3), CONFIRM TdT
TAG-72 (B72.3) PMS2 (EPR3947) C4, FITC Hematopathology CD56 (MRQ-42) TRAcP (9C5)
Topoisomerase IIa (JS5B4), Dermatopathology Fibrinogen, FITC ALK1 (ALK01), CONFIRM CD57 (NK-1) ZAP-70 (2F3.2)
CONFIRM Albumin, FITC Kappa, FITC Annexin A1 (MRQ-3) CD61 (2f2)
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Breast cancer diagnostics

Empowering clinical confidence
Roche Diagnostics delivers a comprehensive Analytical superiority

Lung EGFR L858R (SP125) Prostate
ALK (D5F3), VENTANA EMA (Epithelial Membrane Antigen) Androgen Receptor (SP107)
suite of validated immunohistochemistry • Specific and sensitive rabbit monoclonal
c-MET Total (SP44), CONFIRM (E29), CONFIRM Basal Cell Cocktail (34ßE12+p63), and in situ hybridisation diagnostic solutions antibodies, best-in-class probes and
Calretinin (SP65), CONFIRM Epithelial-Related Antigen (MOC-31) VENTANA for breast cancer — so you can deliver the powerful detection systems
Carcinoembryonic Antigen (CEA) Epithelial-Specific Antigen/Ep-CAM Cytokeratin 5/6 (D5/16B4) right test, with clinical confidence.
(TF3H8-1) (Ber-EP4) Cytokeratin 7 (SP52), CONFIRM
Testing efficiency
Caveolin-1 (SP43) IGF-1R(G11), CONFIRM Cytokeratin 20 (SP33), CONFIRM
CD56 (123C3), CONFIRM Mesothelial Cell HBME-1 (HBME-1) ERG (EPR3864)
Our breast cancer predictive diagnostic • Comprehensive breast cancer solution
CD56 (MRQ-42) MUC1 (H23) EZH2 (SP129) offerings (HER2 IHC and ISH, ER, PR) in • Fully automated assays, with digital
CEA (CEA31) Napsin A (MRQ-60) p63 (4A4), VENTANA combination with our supporting diagnostic pathology and workflow solutions
Chromogranin A (LK2H10) NSE (MRQ-55) PSA, CONFIRM assays (Ki-67, p120 and E-cadherin) are
Cytokeratin (CAM 5.2) p40 (BC28) PSA (ER-PR8)
fully automated on BenchMark IHC/ISH Product characteristics
Cytokeratin 5 (SP27) p63 (4A4), VENTANA PSAP (PASE/4LJ)
Cytokeratin 5/6 (D5/16B4) Pan Keratin (AE1/AE3/PCK26) Primary
staining platforms that reduce the time to INFORM HER2 Dual ISH DNA Probe
Cytokeratin 5/14 (EP1601Y/LL002) Antibody result and resources required compared to Cocktail assay
Cytokeratin 7 (SP52), CONFIRM PD-L1 (SP263), VENTANA manual or semiautomated solutions. • Brightfield detection allows evaluation
Cytokeratin 17 (SP95) SOX-2 (SP76) of HER2 gene status with morphological
Cytokeratin 20 (SP33), CONFIRM Synaptophysin (MRQ-40)
Your benefit context
E-cadherin (36), VENTANA Synaptophysin (SP11), CONFIRM
E-cadherin (EP700Y) TAG-72 (B72.3)
Clinical superiority
EGFR E746-A750 del (SP111) Thyroid Transcription Factor-1 • High accuracy and clinical confidence HER2 (4B5) Rabbit Monoclonal Antibody
(8G7G3/1), CONFIRM
EGFR (Epidermal Growth Factor in a short turnaround time to identify • Clinical confidence with a world-class
Receptor) (5B7), CONFIRM Thyroid Transcription Factor-1 (SP141) patients other assays can miss HER2 rabbit monoclonal antibody
EGFR (Epidermal Growth Factor WT1 (6F-H2)
Receptor) (3C6), CONFIRM
Breast carcinoma INFORM HER2 Dual ISH DNA Probe Breast carcinoma HER2 (4B5) positive Score: 3+;
Cocktail n on-amplified; magnification: 40X. magnification: 40X.
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Cervical disease diagnostics
The Roche and Ventana Medical Systems, Over 100 publications, medical society 1 Darragh, T. M., et al. (2012). Archives of pathology &
Inc. (Ventana) cervical cancer portolio recommendations1 as well as a major laboratory medicine, 136 (10), 1266-1297. doi:10.5858/
arpa.LGT200570.
helps protect women from cervical cancer Pan-European clinical study2 support the
2 Bergeron, C., et al. (2010). Am J Clin Pathol.133 (3),
and from overtreatment. CINtec® prod- scientific and medical value of the CINtec®
395-406.doi:10.1309/AJCPXSVCDZ3D5MZM.
ucts, available exclusively from Roche p16 Histology product for use in cervical 3 Petry, K.U., et al. (2011). Gynecol Oncol. 121 (3), 505-509.
and Ventana are the only IVD (in vitro biopsy specimens. doi: 10.1016/j.ygyno.2011.02.033.
diagnostics) products to detect the overex- 4 Schmidt, D., et al. (2011). Cancer Cytopathol. 119(3),
158-166. doi:10.1002/cncy.20140.
pression of the cellular protein p16INK4a (p16) CINtec® PLUS — Improving accuracy
5 Wentzensen, N., et al. (2012). Clin Cancer Res. 18,
in cervical cytology and tissue specimens. for detecting high-grade disease in
4154-4162. doi: 10.1158/1078-0432.CCR-12-0270.
Used adjunctively with available clinical cervical cancer screening Diffuse p16 immunostained cervical specimen demon-
information, the CINtec® products empower The CINtec® PLUS Cytology immunocyto- strating a positive CINtec® p16 Histology result
you to make informed, confident decisions. chemistry assay provides simultaneous quali-
tative detection of p16 and Ki-67 proteins in
The over-expression of p16 (a cyclin- cervical cytology preparations. This advanced
dependent kinase inhibitor) in cervical combination of biomarkers provides high
specimens, detected by CINtec® immuno- sensitivity and high specificity in a single test.
histochemistry products, is highly correlated CINtec® PLUS Cytology identifies underlying
with oncogenic transformation caused by high-grade cervical disease in cytology spec-
persistent high-risk HPV (hrHPV) infections imens and helps identify women with trans-
forming cervical lesions (p16/Ki-67 positive)
CINtec® p16 Histology – Seeing beyond who need colposcopy.3,4,5
Co-expression of p16INK4a (brown cytoplasmic immu-
H&E in cervical cancer diagnostics nostain) and Ki-67 (red nuclear immunostain) within
The CINtec® p16 Histology product is part of * C INtec® PLUS Cytology is a CE/IVD product, intended
the same cell demonstrates a positive CINtec® PLUS
for clinical use. CINtec® PLUS Cytology is not available
a fully automated immunohistochemistry Cytology result
for this use in the United States, Canada, China or
(IHC) assay for the qualitative detection of the Japan. Check with your local Roche representative for
p16 protein on slides prepared from formalin- the availability of products in your region and the applicable
fixed, paraffin-embedded cervical biopsies. intended use.
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Colorectal diagnostics
Assist in diagnosis, risk stratification and
subtyping of colorectal cancer
The stages and subtypes of colorectal Mismatch repair IHC staining patterns in colorectal cancer
cancer vary significantly in prognosis and
MMR mutations IHC result MLH1 IHC result PMS2 IHC result MSH2 IHC result MSH6
treatment options, demonstrating a need
MLH1 mutation Loss Loss Preserved Preserved
for tools that assist pathologists in detecting
and subtyping colorectal malignancies.
Ventana offers a comprehensive panel of

ready-to-use rabbit and mouse colorectal BRAF V600E (VE1) Mouse Monoclonal Primary Antibody
assays, including IHC assays for the four MSH2 mutation Preserved Preserved Loss Loss
most common mismatch repair (MMR) Informing clinical decisions
proteins, MLH-1 (M1) Mouse Monoclonal Ventana colorectal and gastrointestinal
Primary Antibody, MSH2 (G219-1129), tools aid in diagnosis, subtyping and risk
CONFIRM MSH6 (44) Mouse Monoclonal stratification with ready-to-use assays
Primary Antibody and PMS2 (EPR3947), that include:
along with the BRAF V600E (VE1) Mouse • MMR protein and BRAF V600E (VE1) MSH6 mutation Preserved Preserved Preserved Loss
Monoclonal Primary Antibody, for use on assays facilitate efficient and cost-effective
the fully-automated BenchMark series subtyping within the anatomic pathology
IHC/ISH platforms. laboratory
• Gastrointestinal IHC assays such as PATH-
The Ventana colorectal primary antibodies WAY c-KIT (9.7) Primary Antibody and
PMS2 mutation Preserved Loss Preserved Preserved
assist in diagnosis, risk stratification and Ventana Helicobacter pylori (SP48) Rabbit
subtyping while helping inform clinical Monoclonal Primary Antibody
decisions, and are supported by innovative • Highly sensitive and specific rabbit and
automation, detection and workflow solutions. mouse monoclonal assays
Powered by the OptiView DAB IHC detection system.
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Hematopathology diagnostics
A comprehensive solution helping you
detect and subtype
Hematological cancers vary significantly Comprehensive menu to aid in diagnosis CD30: cornerstone biomarker that helps
in both prognosis and aggressiveness, and subtyping inform clinical decisions
demonstrating a need for tools that assist
pathologists in making confident diagnoses
and helping to inform clinical decisions. We
offer over 65 cornerstone and novel hemato-
pathology ready-to-use reagents, including
key IHC antibodies and ISH probes, that aid
in the detection of lymphomas, leukemias
and other hematopoietic malignancies. bcl-2 (SP66) Rabbit Monoclonal Primary Antibody CD30 (Ber-H2) Mouse Monoclonal Primary Antibody
The dynamic range of Ventana OptiView Ventana hematopathology suite of ready- We are excited to provide you with the refor-
DAB IHC detection delivers unparalleled to-use immunohistochemistry (IHC) and in mulated CD30 (Ber-H2) Mouse Monoclonal
sensitivity and specificity so you can detect situ hybridization (ISH) assays feature: Primary Antibody. A cornerstone tissue
antigens across a wide range of expression • Exclusive assays such as the BRAF V600E marker for lymphoma, CD30 delivers clinical
levels. Our hematopathology assays are (VE1) Mouse Monoclonal Primary Antibody confidence by aiding the pathologist in:
optimized for use on the fully automated • New products such as SOX-11 (MRQ-58) • Diagnosis of T-cell and B-cell lymphomas
Ventana BenchMark IHC/ISH series Mouse Monoclonal Primary Antibody, • Identification of Reed-Sternberg cells in
of instruments to maximize quality and CD13 (SP187) Rabbit Monoclonal Primary Hodgkins Lymphoma (HL)
laboratory efficiency. Antibody and CD16 (SP175) Rabbit • Diagnosis of Anaplastic Large Cell
Monoclonal Primary Antibody Lymphoma (ALCL)
• Choice of detection systems that
allows visualization of antigens with This reformulation features updated proto-
low expression cols for both OptiView DAB Detection and
ultraView Universal DAB IHC Detection.
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Lung cancer diagnostic solutions

Driving Personalized Healthcare with key
markers for detection and subtyping
The statistics associated with lung cancer Our portfolio of products, which includes Gain a clear view by detecting ALK and PD-L1 protein expression
clearly demonstrate the aggressive nature rabbit monoclonal antibodies, novel
of this deadly disease, Roche Diagnostics biomarkers and detection kits, delivers
offers a robust menu of tools to aid in the the high sensitivity and specificity needed
diagnosis of patients facing this challenge. from diagnostic assays.
“With the introduction of targeted therapies
that can result in dramatically different out- Our antibodies are ready to use on the fully
comes based on subtype, the importance of automated BenchMark IHC/ISH series
accurate classification has been amplified.”1 of instruments, reducing the time-to-result
and resources required with manual or NSCLC stained with VENTANA ALK (D5F3), NSCLC stained with VENTANA PD-L1 (SP263)
semi-automated solutions. and OptiView DAB IHC detection with AMP
Differentiating between adenocarcinoma and squamous cell carcinoma VENTANA ALK (D5F3) Rabbit VENTANA PD-L1 (SP263) Rabbit
Confidently differentiate between lung Monoclonal Primary Antibody Monoclonal Primary Antibody
adenocarcinoma (ADC) and squamous cell VENTANA ALK (D5F3) is indicated as an aid The VENTANA PD-L1 (SP263) antibody
carcinoma (SCC) with four key markers, in identifying patients eligible for treatment is produced against programmed death-
including the p40 (BC28) Mouse Monoclonal with XALKORI (crizotinib). It is, therefore, ligand 1 (PD-L1) B7 homolog 1 (B7-H1,
Primary Antibody. critical that ALK positive patients are CD274). It recognizes a transmembrane
accurately identified. Shaw et al. highlights bound glycoprotein that has a molecular
p40 (BC28) Mouse Monoclonal this importance and demonstrates that mass of 45 – 55 kDa. This antibody produces
Primary Antibody ALK testing via IHC represents a reliable membranous, and/or cytoplasmic staining.
p40 (BC28) is a sensitive and specific anti- Squamous cell carcinoma stained positive with the p40 and cost effective alternative to FISH.3
body for the detection of the p40 (Np63) (BC28) assay using OptiView DAB IHC detection It is indicated as an aid in the assessment
protein. In a panel with other key markers Clone D5F3 has been identified as “one of PD-L1 expression in non-small cell lung
1 Tacha, D., Yu, C., Bremer, R., Qi, W., Haas, T. (2012).
in our portfolio (TTF-1, CK 5/6, Napsin A), Appl Immunohistochem Mol Morphol 20, 201-207. of the most promising antibodies for the cancer (NSCLC) and other tumor types.5
p40 (BC28) can provide an accurate and 2 Wei, Z., Hui, W., Yan, P., Bo, T., Lei, P., Da-Chuan, Z. detection of ALK rearrangement in NSCLC.”
4 Minca et al. (2013). J Mol Diagn. 15(3).
reliable method for differentiating pulmonary (2014). Np63, CK5/6, TTF-1 and napsin A, a reliable In a study of 296 patients with advanced 5 Zou, W., Chen, L. (2008). Inhibitory B7-family
adenocarcinoma from squamous cell panel to subtype non-small cell lung cancer in biopsy NSCLC clinically referred for ALK testing, molecules in the tumour microenvironment.
specimens. Int J Clin Exp Pathol, 7(7), 4247-4253.
carcinoma.2 the “ultrasensitive” VENTANA ALK (D5F3) Nat Rev Immunol, 8(6), 467-77.
3 Shaw et al. (2011). J Natl. Compr. Canc. Netw.
9,1335-1341. assay showed high correlation with FISH
and 100 % sensitivity and specificity.4
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Prostate cancer diagnostics Connectivity solutions

Diagnostic solutions and innovative tools
for emerging utility
Our prostate cancer diagnostic portfolio Work confidently with Connectivity Solutions performance, decreased downtime and
can give you the confidence you need to from Ventana that help you optimize lab world-class customer support. Your
improve patient care. efficiency, patient safety, and equipment instruments are talking; CareGiver remote
uptime through direct connections to your support is listening.
Empower your lab with our portfolio of bio- Ventana platforms. From remote support
markers that deliver increased value for men’s to Laboratory Information Systems (LIS) Ventana Connect software solution
health. Our antibodies are pre-diluted and connectivity, we have you covered. Ventana Connect software moves critical
optimized for use on the BenchMark IHC/ISH information between multiple LIS systems
series of automated platforms for efficient, CareGiver Remote Support and Ventana instruments enabling more
reproducible staining quality. We continue Prostate carcinoma stained with ERG (EPR3864) Rabbit Monitoring your lab’s Ventana instruments efficient workflow. Discover Ventana
to d
evelop novel biomarkers with promising Monoclonal Primary Antibody in real-time, the Ventana CareGiver remote Connect software.
utility — such as the EZH2 (SP129) Rabbit support software delivers enhanced system
Monoclonal A ntibody and the A
ndrogen Re- • Consistently strong nuclear staining allows
ceptor (SP107) Rabbit Monoclonal Antibody. for easier interpretation
• Like high molecular weight cytokeratin
ERG (EPR3864) Rabbit Monoclonal 34βE12, p63 is specific and sensitive for
Primary Antibody basal cells in the prostate gland
Developed for high sensitivity and specificity,
the ERG (EPR3864) Rabbit Monoclonal Ventana Basal Cell Cocktail
Primary Antibody delivers: 34βE12+p63
• Specificity for prostate cancer which may Our Basal Cell Cocktail combines p63 (4A4)
aid in detection and diagnosis with 34βE12 to aid in the differentiation of
• Ability to identify a molecular prostate benign and malignant prostatic lesions.
cancer subtype • Increases the sensitivity of basal cell
• High concordance to ERG FISH detection
• Decreases staining variability
Ventana p63 (4A4) Mouse Monoclonal • Offers more consistent basal cell
Primary Antibody immunostaining
The p63 (4A4) antibody empowers you to
make informed, confident decisions.
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VANTAGE workflow solution

A proven system for quality to increase
patient safety
Today’s histology lab managers are under Your benefit Full and fast control
increasing pressure to improve laboratory Eliminate redundancies, reduce errors • Locate any specimen, block or slide
workflow, sample tracking, quality and • Reduce data re-entry, relabelling and immediately
patient safety. labelling errors with “one label, one time” • Ask the VANTAGE system to locate any
technology and barcode scanners at patient’s slide, on any instrument, at any
VANTAGE solutions have been designed to every workstation point in your process — and count on
enable histology laboratories to address immediate, accurate results
these challenges: Lean workflow
• Prevent bottlenecks before they happen. Full transparency
Our comprehensive solution for histology The VANTAGE workflow solution gives • Populate patient details accurately
labs — hardware, software and workflow you a clear view of your lab, so you can • Retrieve patient details with a quick
consulting — offers a commanding view of maintain optimal performance barcode scan
your complex operation from a single • Collaborate with lean histology experts to
strategic perspective. It is an end-to-end improve your workflow Product characteristics
product that automates, streamlines and • Simplify workflow steps • Includes all Ventana connect
integrates lab work and information flow • See a comprehensive dashboard of lab characteristics
to help provide maximum productivity performance at any time • Cassette verification/identification
and improvements to patient safety. The • Identify opportunities to improve quality, • Slide label generation and management
VANTAGE workflow solution is designed staffing and efficiency • Harmonised unique slide identification
using Lean Six Sigma principles and in- • Centralized instrument slide/test status
cludes expert workflow consulting support Establish your chain of custody • Specimen chain of custody
to help you obtain immediate and ongoing • The VANTAGE workflow management • Block/slide tracking and locating
workflow benefits. system brings all of our automated • Workflow process report and
platforms together, creating a chain of workload statistics
custody that encompasses your entire lab • QA/QC management and reports
• Specimen archive
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Companion diagnostics
Deliver Personalized Healthcare
to those who need it
For every ten cancer patients treated, an Partner of choice for companion Helping to deliver the promise
average of only half will benefit. For some, diagnostics of Personalized Healthcare
the treatment won’t have any effect; others A global leader in tissue-based cancer Tissue diagnostics: no other technology
may suffer from serious side effects.1 diagnostics, we provide a premier end-to- captures the anatomical context that helps
Ventana Medical Systems, Inc. is working end offering, with expertise at every stage determine patient outcomes and enables
at our industry’s forefront to change this from discovery to commercialization. Working Personalized Healthcare:
dynamic by customizing therapy to individual together under one roof, Ventana and •C ompanion tissue tests help determine the
patients, helping you to improve diagnostic pharma increase the efficiency and speed best course of treatment
accuracy, lab efficiency and patient safety. of developing patient selection biomarkers. • We are committed to expanding our market-
•B rings 180+ biomarker projects with a leading HER2 diagnostic franchise VENTANA ALK (D5F3) Rabbit Monoclonal Antibody
In collaboration with leading pharmaceutical strong track record — reliably on time • T he Ventana ALK IHC Rabbit Monoclonal
companies, we identify and develop inno- and on budget Primary Antibody aids in early detection
vative companion diagnostics to target • Provides global access through the and treatment decisions for non-small cell
those patients who are likely to respond to Ventana and Roche commercial network lung cancer patients
specific therapies. Because we recognize and installed base • T he majority of the Roche oncology-focused
the tremendous potential for these solutions, •O ffers a differentiated, broad instrument targeted therapies, currently in late stage
we continue to focus on addressing unmet and reagent portfolio clinical trials, have an associated VENTANA
medical needs by developing the cutting- tissue companion diagnostic
edge tools you need.
INFORM HER2 Dual ISH DNA Probe Cocktail Assay

You can be confident that Ventana products,
only from Roche, are the right solution to
empower you to deliver the highest-quality
diagnostic information for patients — today
and in the future.
1 Source: Roche Personalized Healthcare brochure, 2011.
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Digital pathology
Virtual consultation, image analysis
and education
Roche Digital Pathology is transforming Your benefit Product features

the practice of pathology by developing Virtual consultation VENTANA Virtuoso image and workflow
innovative technologies that deliver • Maximize pathologist time management software
medical value, inform decision making and • Enable flexibility for tumor boards, case • Anytime, anywhere access to slide images
improve cancer care. The integrated sharing and collaboration • Optimized digital workflow and decision-
solution consists of high-quality scanners, • Enable fast turnaround time for expert making environment
image analysis software, image and opinions • Web-based application to support remote
workflow management software and • Provide access to sub-specialists consults and image analysis
education applications, all working
together globally to optimize laboratories. Image analysis VENTANA Companion Algorithm image
Digital pathology enables more efficient • Build clinical confidence with US and analysis software VENTANA iScan HT slide scanner
and informed treatment decisions for CE – IVD validated Companion Algorithm • US and CE – IVD validated image analysis • Intended for high-volume scanning sites
patients — enhancing care by eliminating image analysis software algorithms for the full breast panel: HER2, • Brightfield scanning capability
the boundaries of time and distance. • Facilitate consistent, objective ER, PR, Ki-67 and p53 (360 slide capacity) at various
interpretations for breast IHC — verified • Semi-quantitative scores for markers magnifications — 20x, 40x
by a pathologist — for every patient requiring cell counts • Continuous random access and STAT
• Fully validated as part of a systems processing — with no workflow interruption
Education approach — includes reagents, staining
• Enrich and accelerate learning in a platforms, scanners and software VENTANA Vector education and
collaborative environment collaboration software
• Allow students to review material anywhere, VENTANA iScan Coreo slide scanner • Support education and collaboration with
anytime, from the device of their choice • Intended for low- to mid-volume digital images
scanning sites • Standardize content and eliminate sharing
• Brightfield scanning capability resources (slides or microscopes)
(160 slide capacity) at various • Allow students to review material
magnifications — 4x, 10x, 20x, 40x anywhere, anytime, from the device of
• Live mode (remotely controlled robotic their choice (mobile-capable on iOS and
microscope) Android devices)
Digital pathology
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Sequencing solutions
Clinical research Roche Sequencing provides researchers with
innovative tools for next-gen sequencing
sequencing platforms. This portfolio of
products allows researchers to selectively
DNA sequencing workflow, including instruments, reagents

and target enrichment products. This portfo-
sequence the human exome, human dis-
ease-associated genes, or genomic
Innovation
lio of next-generation sequencing products regions of interest in a wide range of
is driving research advances in cancer, infec- non-human species. The broad portfolio
tious diseases, inherited genetic diseases, of products with complete customization
Sequence capture immunogenetics, drug discovery, agriculture,

environmental ecology and more.
enables researchers to achieve best-in-
class target enrichment efficiency and
GS Junior
uniform coverage in variant detection.
Roche’s 454 Sequencing Systems spear-
headed the post-Sanger era with the first Roche Sequencing offers researchers a
next-generation sequencing system. The clearer understanding of genomic struc-
GS FLX+ System andbenchtop GS Junior ture and function in order to understand
System offer a unique combination of pow- the impact of genes on biological process-
erful next-generation sequencing through- es. As pioneers in sequencing with a rich
put and long, accurate read lengths (up to heritage in diagnostics, the Roche Se-
1,000 bp). The systems allow you to move quencing Unit is committed to a future
quickly from sample to result with easy- that fosters innovation to provide solutions
to-interpret data and dedicated analysis that enable scientific discovery and deliver
software. clinical value – We are Changing Science
and Changing Lives.
NimbleGen SeqCap Target Enrichment
Systems are designed to enrich target DNA For more information please
regions for a variety of next-generation visit www.roche-sequencing.com

Not for use in diagnostic procedures.
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Genome Sequencer FLX+ System

Sanger-like read lengths – the power of
next-generation throughput
Roche’s portfolio of proven DNA sequenc- Your benefit The Genome Sequencer FLX+ System
ing and target enrichment solutions are Fast results – sequence with confidence
advancing research in human health, agri- • Generate 700 million bases Up to 1,000 bp read length – get all the
culture, evolutionary biology, and more. per 23 hours run benefits of Sanger capillary sequencing
The GS FLX+ System and benchtop GS with the power of next-gen throughput to
Junior System offer the unique combination More comprehensive data take your research to the next level. Trusted
of powerful next-generation sequencing • Take advantage of the Sanger-like read results in over 1,300 publications:
throughput and the familiarity of long length up to 1 kb • Identification of a novel arenavirus re-
Sanger-like read lengths (up to 1,000 bp). • Includes powerful and easy-to-use sponsible for a series of fatal transplant-
Data Analysis SW associated diseases in Australia
NimbleGen SeqCap Target Enrichment Sys- • Generation of the first complete genome
tems prepare DNA samples for a variety of Widest application range and flexibility and exome sequences from the hunter-
next-generation sequencing platforms, al- • Cover all applications gatherer people of southern Africa
lowing researchers to selectively sequence • Gain project flexibility by utilizing • Sequencing of rearranged VDJ immune
specific human exome and disease-associ- different plate formats, gaskets and receptor loci tracks immune diversity and
ated regions. The broad portfolio of prod- multiplex identifiers clonal lymphocyte population
ucts with complete customization enables
researchers to minimize sequencing costs
in variant discovery studies. Product characteristics
Throughput 700 Mb per 23 hours run

Read length Up to 1,000 bp
Consensus accuracy 99.997 %
Data processing and Perform data analysis without the need for enterprise scale IT solutions with
bioinformatics preinstalled, easy-to-use software tools:
• GS De Novo Assembler
• GS Reference Mapper-GS Amplicon Variant Analyzer
Applications • De novo sequencing
• Re-sequencing
• Sequence capture/targeted resequencing
• Transcriptome analysis
• Gene regulation studies
• Epigenetic changes
For life science research only. • Metagenomes and microbial diversity
Not for use in diagnostic procedures. • Ancient DNA
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GS Junior System
The power of next-generation sequencing
on your benchtop
The 454 GS Junior System brings the power Your benefit Product characteristics • Reads per run: 100,000 reads
of next-generation sequencing technology Integrated next-generation sequencing Research application (on average)
directly to your benchtop, opening the door • Established easy-to-use technology • Unambiguously resolve highly complex • Sample input: gDNA, amplicons, cDNA,
to a new revolution in genomic research and Roche sequencing expertise genomic regions (e.g., HLA, IgH) or BACs depending on the application
sequencing for every day and everyone. • Discover germline or somatic mutations • Computing: HP desktop computer;
Access to next-generation sequencing will Increased lab productivity in oncology (e.g., EGFR, KRAS, BRAF, All software is point-and-click
no longer be limited to large facilities with • Reproducible data, short run times PI3K, BRCA), hematology (e.g., TET2, CBL,
the budget and infrastructure previously and complete data analysis solutions RUNX1, RAS), and metabolic diseases GS Junior applications
required to accommodate the high demands (e.g., CFTR, MODY) • Zoom into critical genomic regions using
of the emerging technology. Broad application versatility • Detect low-frequency variants such amplicon sequencing of PCR products
• Due to read length, throughput, as rare drug-resistant viral mutations and sequence capture technologies
sensitivity and read accuracy (e.g., HIV*) • Quickly perform haplotyping, genotyping,
• Throughput: >35 million high-quality, rare variant detection, structural variant
filtered bases per run detection, and heterozygote calling
• Run time: 10 hours sequencing, 2 hours • Analyze disease-associated regions in
data processing oncology and immunogenetics, or viral
• Read length: ≈ 400 bp quasispecies present within infected
• Accuracy: 99 % accuracy at 400 bases populations in infectiology
An integrated solution – from sample prep to data analysis
GS Junior Titanium Benchtop instrument and computer Data processing

Reagents and accessoires and analysis software
Not for use in diagnostic procedures.
244 | 245
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NimbleGen sequence capture

Confident and efficient genetic variant detection
Next-generation sequencing (NGS) target Your benefit Product characteristics

enrichment enables you to focus on your Most relevant content SeqCap Target Enrichment Systems is a
regions of interest in the human genome, • Uniform coverage of your target region, solution-based c apture method that enables
hence greatly improving variant detection from the leader in custom designs, enrichment of the whole exome or custom-
sensitivity, sample capacity and speed to building highest confidence in variant er regions of interest in a single test tube
results. Compared to other hybridization- detection and data reporting with up to 2.1 million overlapping probes.
based enrichment technologies on the mar-
ket, Roche NimbleGen products provide Proven performance • SeqCap EZ Systems enable enrichment
the highest capture efficiency and cover- • Best-in-class capture efficiency, proven for DNA sequencing on a variety of
age uniformity available1,2, as a result of its by independent leading researchers year product offerings from whole-exome to
superior design algorithms and proprietary over year, leading to optimal sample targeted designs. Additional designs are • SeqCap RNA Systems are designed for
probe synthesis technology. throughput available for custom developed designs, target enrichment of cDNA or RNA. Prod-
or fixed designs agriculture biology, crop ucts are available in a fixed design for
Roche NimbleGen sequence capture Maximum convenience genomes, or model organisms. researching long-coding RNA or custom
products have enabled effective enrichment • Complete and cost-effective enrichment • SeqCap Epi Systems enable enrichment designs can be developed for human or
of a wide variety of genome regions from workflow coverage, from one source, of bisulfite treated DNA for epigenomic model organisms.
a broad range of sample types for high- greatly simplifying your validation process applications of research. Products are • NimbleDesign is a free online tool that
fidelity detection of SNVs (single nucleotide available in a fixed design for whole- enables you to quickly and easily design
variations), CNVs (copy number variations), exome epigenomic analysis, or custom SeqCap EZ Choice and SeqCap RNA
indels (insertions and deletions), transloca- designs can be developed for human or Choice Systems.
tions, epigenomic events, RNA transcrip- model organisms.
tion and more.
For life science research only. 1 Clark, M., et al. (2011).Nat. Biotech.; doi:10.1038/nbt.1975.
Not for use in diagnostic procedures. 2 Bodi, K., et al. (2013). J Biomol Tech. Jul;24(2):73-86. doi: 10.7171/jbt.13-2402-002.
246 | 247
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Consultancy services
Consultancy Healthcare budgets are continually being

squeezed, which means laboratories and
Based on our experience in serving labora-
tories for IVD testing, and supported by
Laboratories
other diagnostic service providers are faced global and local experts, Roche provides
not just with operational but also commer- consultancy services for all areas of testing,
cial challenges. including molecular and tissue diagnostics.
Efficiency Budget cuts, lack of personnel, limited Roche’s mission is not only to help imple-
Future space, attracting new customers and

promoting the value of diagnostic services
ment an optimal, future-proof solution
but also to work with service providers in
Quality
– all of these factors have become impor- developing a service strategy that is able
tant considerations. to cope with the many demands of a
constantly changing market.
Workflow solution
cobas
Continuous improvement
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Consultancy services
Inspiring continuous improvement
In a climate of deep financial crisis and Your benefit Consultancy process

acute competition, laboratories need to • Empower your people to embrace Laboratory service performance
evolve their business into a model that continuous performance improvement improvement:
allows them the flexibility to react efficiently • Co-derived sustainable solutions with • Identification of strategic goals
to a very fast healthcare market dynamic. optimized workflow • Analysis of main streams using LEAN
• Rapid implementation according to fact management methodology to derive the
The Roche consultancy team can help you based concept optimum solution
build the right, fact based strategy to • Increase operational efficiency and • Implementation of proposed solution
meet both current and future demand. They effectiveness through a series of rapid improvement
will support you in the implementation • A working environment with harmonised events which will validate the proposed
of the strategy by building LEAN efficient prosperity and performance solutions
processes and selecting the right equipment • Long term sustainable partnership • Monitoring of improvement through the
to precisely match the clinical needs benefit tracker which will indicate the
securing a direct transfer of the value of your status in concrete KPI’s for each milestone
services into outstanding patient outcome.
A structured approach
6. Continuous improvement 1. Scoping

Assess on-going performance Scope the project,
against KPIs and through define objectives and
benchmarking deliverables
Insightful analysis
and derived solutions
5. Implementation 2. Fact-finding
based on LEAN
Empower staff to Value stream mapping
management structure
continually look for of sample journey from
for continuous
process improvements requesting to results delivery
and sustainable
Measure process
improvement
performance within the value
stream maps to identify bottlenecks
4. Devised solution 3. Analysis

Specifically tailored to your service Gap analysis to reveal difference between
Pilot and measure recommended improvement plan current state and target objectives
Derive improvement plan
250 | 251
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Roche DiaLog
Digital Services The consolidation and growth of medical

laboratories is leading to ever-more
complex processes and diagnostics systems
Easy are evolving constantly to keep pace.
Simple This brings challenges for the people who

use them. To make life easier, R
oche has
Engaging developed a one-stop solution that makes

every aspect of laboratory management
Transparent easier and more efficient.
Relevant information
Collaboration
252 | 253
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Roche DiaLog
The changing world of diagnostics
Introducing Roche DiaLog ing past orders, delivery notes and invoices Digital Services
A single platform designed to give you faster and track the connections among them.
and more convenient online access to all the • Inventory Management allows to maintain
information and services you need. stock levels always under control for both
Roche and non-Roche products. It tracks the
Your benefit goods usage and suggests replenishment
• Simplicity: one gateway to Roche actions bringing the Inventory to the next
• Increased transparency of your processes step in terms of control and optimization.
• Receive personalized support • Live chat is an additional support channel,
• Stay up-to-date providing direct access to Roche support
agents whenever needed. Live chat also
Product characteristics enables exchanging pictures or docu-
Roche DiaLog: One point of entry to all ments to help better explain challenges
Roche Diagnostics digital services. Access and resolutions.
to Roche with just one login and password
from any device (pc, tablet, mobile). Facili- And this is just the beginning. Roche DiaLog
tates engaging interaction for a new form of is always evolving, continuously introducing
direct two-way communication that’s simple, improvements and new services.
always open, personalized and up-to-date.
Current offering*:
Digital Services are applications to
Technical
support your core business. Documents
They include: Track & Trace

• Technical documents provides instant ac-
cess to all documentation to operate instru- Inventory
Management
ments and reagents. It contains a powerful
search-engine and the ability to get notified Live Chat Events News Videos
when new documents become available.
• Track & Trace provides a comprehensive over-
view of all order-related information, includ- *Not all services are available in all countries.
254 | 255
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Trademarks
All mentioned trademarks are owned by or
licensed to a Member of the Roche Group
ACCU-CHEK COBAS E INFORM ROCHE CARDIAC Legal statement

ACCU-CHEK INFORM COBAS H INNOVATIS ROCHE MICROSAMPLER No warranty and no liability
ACCU-CHEK PERFORMA COBAS INFINITY iScan Coreo Au SAFE-T-PRO While Roche is making great efforts to
ACCUTREND COBAS INTEGRA IVIEW SEPTIFAST include accurate and up-to-date information,
AMPERASE COBAS P LIFE NEEDS ANSWERS SOFTCLIX we make no representations or warranties,
AMPLICHIP COBAS S LIGHTCYCLER SYMPHONY express or implied, as to the accuracy or
AMPLICOR COBAS U LINEAR ARRAY TAQMAN completeness of the information provided in
AMPLILINK COBAS X MAGNA PURE TARCEVA this brochure and disclaim any liability for
AUTOQC COBAS Z MGRADE TINA-QUANT the use of it. Neither Roche nor any other
AMPLIPREP COMBUR 10 TEST MODULAR TROPT party involved in creating, producing or
BENCHMARK COMBUR 7 TEST MODULAR ANALYTICS EVO ultraVIEW delivering this brochure shall be liable in
CASY COMBUR 5 TEST MODULAR PRE-ANALYTICS URISYS any manner whatsoever for any direct,
CEDEX COMBUR-TEST EVO URISYS 1100 incidental, consequential, indirect or puni-
CELLAVISTA CONFIRM MRSA ADVANCED URISYS 2400 tive damages arising out of any errors or
CINTEC DISCOVERY NIMBLEGEN VANTAGE omissions in the brochure contents.
COAGUCHEK ELECSYS OPTIVIEW VENTANA
COASYS COBAS 454 PATHWAY VIRTUOSO Forward-looking information
COBAS GENOME SEQUENCER PEGASYS XCELLIGENCE This brochure may contain forward-looking
COBAS B GS JUNIOR PRECINORM ZELBORAF information. Such information is subject
COBAS BGE LINK GS FLX REALTIME READY to a variety of significant uncertainties,
COBAS C HERCEPTIN REFLOTRON including scientific, business, economic
and financial factors, and therefore actual
results may differ significantly from those
presented.
The document is not intended to be

distributed in the US.
Please check with your local Roche representative

on availability of products listed in this document in
Other brands or product names are trademarks of their respective holders. your country.
256 | 257
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Roche Diagnostics test portfolio

Roche Diagnostics test portfolio
Valproic Procain- Pheno- Everolimus

Phenytoin Acid Primidone amide barbital NAPA Amikacin Lidocaine Lithium
Salicylate Sirolimus
RSV
Methadone ETOH free
free
Propoxyphene LSD Gentamicin Valproic
BENZO Phenytoin Cyclosporine Tacrolimus
EDDP Cocaine Digoxin Acid %Quick PT INR Influenza A/B
Serum Fibrinogen
CRP hs ADPtest
Methaqualone Theophylline Tobramycin BENZO MPA Digitoxin D-Dimer TRAPtest RISTOtest COLtest ASPItest
LP (a) HEV
Quinidine THC BARB MYO NT-proBNP Trop T Trop T-hs Trop I CK CK-MB GDF-15* aPTT PT Quick DRVVT
T-uptake TSH Serum ATIII APC-R LMWH Crystals KET confirm
Opiates
Vancomycin BARB LDL UFH DRVVT VRE
Tg Thrombin time Antithrombin screen
Oxycodone Parvo B 19 HBDH Protein S Clarity Nit
T4 C diff
C-Peptide Cortisol ACTH Muc
Calcitonin ACETA CARBA AMPH Na Insulin
Anti-TSH-R Lactate AMY Protein C Yeast
MPX (HIV/ CHOL Mg Color pH
Phencyclidine MTB
HCV/HBV) HDL APO B APO A1 HbA1c AMY-P Sperm
T3
ACP FT4 FT3 Anti-TPO Anti-Tg anti-
HCV RNA HBsAg quant HBc-IgM anti-HBs HBeAg LIP BIL Prot MRSA
HBsAg Homo- FRUC PC
hGH cysteine
HIV anti-HBe anti-HBc
ERY SG WNV
HIV RNA qual B2MG
A1MG Uric acid Urea/BUN TP-U/CSF CREA Cystatin C K ALB Micro-ALB HC
IGF-1* HBV DNA CA 125 EC DPX
CEA (B19V,HAV)
AFP AMH DHEA-S E2 FSH LH Progesterone Prolactin SHBG Testosterone
IgG CMV DNA HE4 NSEC UBG
hCG PIGF Osteo- Vit D CA Phosphorus RPR Syphilis
CSF hCG+ß fßhCG PAPP-A sFIt-1
IgA CT/NG calcin total Gluc
CERU
CSF
IgG anti-HCV PTH (1-84) PTH ßXLaps P1NP Rubella IgG CO2 TRIG TP TPLA
IgA C4 LEU Syphilis
Toxo
HPV CRP anti- anti- HIV HIV-Ag CMV HSV-2 HSV-1
Rubella IgM Cl
HAV HAV IgM combi PT IgM IgM
IgM Iron GLDH
C3c ASLO Haptoglobin Toxo IgG Avidity Toxo IgG CMV IgG Avidity CMV IgG Influenza A/B RSV Bacteria Syphilis HTLV-I/II Chagas*
IgM Ferritin
CSF Transferrin sTfR UIBC Vit B 12 LDH Folate CA 15-3 CA 19-9 CA 72-4 CYFRA 21-1 S100 NSE free free free PSA PSA Pro-GRP SCC EGFR KRAS BCR-ABL BRAF
Kappa Lambda
IgE
ALP NH3 ALT/GPT AST/GOT BIL-D BIL-T CHE GGT light light
chains chains
Anti-CCP IL6 PCT Preal- Kappa Lambda
bumin light light
chains chains RF AAGP AAT
Anemia DAT Infectious Diseases Renal Assay

Bone Endocriniology Inflammation TDM Assay in different indications
Map is not exhaustive, does not include Tissue Diagnostics.
Anemia DAT Cardiac Infectious Diseases Fertility Renal Assay Metabolic * in development Women’s Health Different assay in same indication
Status February 2016 Bone Endocrinology Coagulation
Inflammation Hepatology TDM Assay in different Oncology
indications Urinestatus January 2016
Map is not exhaustive, * In development
Cardiac Fertility Metabolic Women’s Health Different assays in same indication
Coagulation Hepatology Oncology Urine
258 | 259
Not for distribution in the US.
For additional information please contact

your local Roche representative.
©2016 Roche
Roche Diagnostics International Ltd

CH-6346 Rotkreuz
Switzerland
www.roche.com

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Products and Solutions 2016

Healthcare is undergoing a paradigm Roche, as global leader in diagnostics,

healthcare spending decision-making

At Roche we combine technical competence with therapeutic insights.

In modern healthcare, in vitro diagnostics decision-making along the entire continuum

• Total lab solutions

Research Clinical applications

Academia Pharma Blood bank Commercial Hospital Physician’s Patient

Healthcare cobas® connection modules (CCM)���������������48

Overview of Serum Work Area tests����������������50

ECL – unique immunoassay technology��������56

Serum Work Area solutions

Clinical chemistry service. Our cobas® platforms offer fully

IT solutions to meet any laboratories needs.

Elecsys Roche’s automated pre- and post-analytical

SWA solutions flexibility and process optimization. We offer

cobas solutions to meet all of your laboratories

An integrated solution combining IVD and For more information please

cobas® modular platform

Today, laboratories are challenged to deliver Your benefit Product characteristics

cobas® 8000 modular analyzer series

The cobas 8000 modular analyzer series Your benefit Consolidation

cobas 8000 modular analyzer series Reagent channels

cobas® 8000 modular analyzer series

cobas 8000 modular analyzer series

cobas® 6000 analyzer series

Optimized workflow 1,500

• Wide range of pre- and post-analytical

• Workflow efficiency and reduced

cobas® 6000 analyzer series

True workflow consolidation Just as every patient requires individualized

1 3 4 cobas p 312 pre-analytical system is

cobas® 4000 analyzer series

cobas c 111 analyzer

COBAS INTEGRA® 400 plus

Unique reagent concept

COBAS INTEGRA 400 plus

cobas c 513 analyzer

The prevalence of patients with diabetes Your benefit Product characteristics

The cobas c 513 analyzer runs Roche’s

Automation & IT solutions

At Roche, laboratory automation solutions 1. Virtual automation 1. Virtual automation

3. Connected automation Commercial Independent

3 Levels of Automation Customized solutions for every lab

cobas middleware solutions

cobas middleware solutions

cobas® infinity IT solutions

cobas® infinity IT solutions

cobas infinity lab link

Manages more than the complexity of lab operations.

Standalone and connected automation cobas p 312

Your benefit cobas p 312 pre-analytical is a standalone

cobas p 512 and cobas p 612

Adapting to today’s needs.

Quality comes first

cobas p 501 and cobas p 701 MODULAR® PRE-ANALYTICS EVO

Product characteristics • Identification of primary sample tubes MODULAR PRE-ANALYTICS EVO is

cobas p 501 post-analytical unit cobas p 701 post-analytical unit

cobas® 8100 automated workflow series

Healthcare cobas® connection modules (CCM)��48

Overview of Serum Work Area tests��50

ECL – unique immunoassay technology��56

Today, laboratories are challenged to deliver Your benefit Product characteristics

The cobas 8000 modular analyzer series Your benefit Consolidation

The prevalence of patients with diabetes Your benefit Product characteristics

Attach Attach p ara- Attach to Voltage Signal count

Infections with Toxoplasma gondii, Rubella Your benefit Product characteristics

In a clinical setting consistent with myo Your benefit Product characteristics

1 B olstad, N. et al (2011). Heterophilic antibody interference in commercial immunoassays.

* LoB = Limit of Blank; LoD = Limit of Detection;

Elecsys Anti-TSHR (TRAK) is a fully auto- Your benefit Product characteristics

assessing ovarian reserve levels and • Traceability: Standardized against BCI

* LoB = Limit of Blank, LoD = Limit of Detection, LoQ = Limit of Quantitation

Preeclampsia is a serious multi-system Your benefit Product characteristics

HbA1c is viewed as a significant and Your benefit Product characteristics