Laboratory Guide 2022
Laboratory Guide 2022
Laboratory Guide 2022
Guide 2022
Valid from 1st January 2022
Cover: Alistair Lam, BMS, performing an agglutation test
for anti streptolysin antibodies.
TAP4942B/14-03-22/V3
Laboratory
Guide 2022
Valid from 1st January 2022
TDL Customer Charter
We are committed to being the most helpful pathology service in the UK. Our goal is
always to provide a high level of service to our customers, who request pathology services,
for their patients. This is a philosophy shared by all Sonic Healthcare Pathology practices.
We are medically led, and patients are our first concern. We always try to look to improve our
operational expertise, and we strive to provide professional leadership within our specialities.
We promise to listen
• We acknowledge customer issues, and try to resolve them promptly and consistently.
• If our delivery has been adversely affected, we will address and review our procedures
so that our service reaches the highest standards.
• We actively ask for feedback so that we can continue to improve our service.
Complaints policy
It is the aim of the company to maintain its core values. Two of these core values are:
Where a doctor or patient needs to raise a complaint about service levels they should contact
Cyril Taylor, Director of Laboratory Compliance, or Annette Wilkinson, Director of Service at
[email protected] giving details of the complaint.
The information forwarded will be treated as confidential and investigated by the above persons.
This process will link into Quality Management procedure for incident investigation.
Corrective and preventative actions will be introduced where indicated.
Contents
PAGE
1
Index of TDL Profiles
TDL SCREENING PROFILES PAGE
DL1/DL1L Biochemistry Profile 24
DL2/DL2L Haematology and Biochemistry Profile (24 parameters) 24
DL3 Haematology Profile 24
DL4/DL4L Haematology and Biochemistry Profile (16 parameters) 24
DL5/DL5L Postal Haematology and Biochemistry Profile 24
DL6/DL6L General Well Person Profile 24
DL7/DL7L Well Man Profile 25
DL8/DL8L Well Person Profile 25
DL9M Senior Male Profile 25
DL9F Senior Female Profile 25
DL10 Cardiovascular Risk Evaluation Profile 25
DL11 Cardiovascular Risk Plus Profile 25
DL12 Sexual Health Screen / 7 STI’s by PCR 25
2
PAGE
Hepatitis Profiles 92
Hirsutism Profile 51, 57
HIV Profiles 67, 77-78, 96-97
HRT Profile 51, 57
Impotence Profile 52, 56
Infertility Male Profile 52, 56
Iron Overload Profile 33, 36, 119, 132
Iron Status Profile 33, 36
Lipid Profile 33, 36
Liver Function Tests 33, 36
Male Genetic Reproductive Profile 116, 120, 132
Menopause Profile 52, 57
Metabolic Syndrome Profile 52, 57
Mineral Screen 147-148
Myeloma Screen 34, 36
Natural Killer Profile 38, 41
Needle Stick Injury Profile 91
Neurological Viral Screen 99-100
Osteoporosis Screen
34, 37
Pituitary Function Profile 52, 57
Pneumonia (Atypical) Screen 99-100
Polycystic Ovary Syndrome Profile 52, 57
Post-Travel Screens 88-89
Pre-Travel Screen 38, 41, 88-89, 123,132
Prostate Profile 101
NEW Prostatitis Screening Panel 43-44
Recurrent Miscarriage Profile 124, 132
Respiratory Viral Screen 99-100
Rheumatology Profiles 82, 86
Rickettsial Species Antibodies 82, 88
Sports/Performance Profile 147-148
STI / Sexual Health Profiles 67-68, 76-78
Thrombotic Risk/Miscarriage Profile 39, 41, 125, 132
Thyroid Profiles 53, 56
Torch Screen 99-100
Trace Metal Screen 148, 159
Tropical Screen 88-89
Urea and Electrolytes 35-36
Viral Profiles 100
Vitamin Screens 147-149
Von Willebrand Profile 39, 41
Personal Profiles (Doctor’s own) are available on request.
3
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Or at any time at
PATIENT RECEPTION/PHLEBOTOMY SERVICES the main laboratory:
76 Wimpole Street, London W1G 9RT The Halo Building
Telephone: 020 7307 7383 1 Mabledon Place
Email: [email protected] London WC1H 9AX
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N20 N9 E4
NW7 N13
N12 N11 N18
N3 N22 N17
E18
N10
N2 E17
NW4 N8
NW9 N15
NW11
N6 E11
N4
N19 E10
N16
E5
NW2 NW3 N5 E12
NW5 N7 E7
E20
E8 E9
NW6 N1 E15
NW10
NW8 NW1 E2 E3 E13
W9 E6
W10 EC
WC E1
W1
W7 W13 W5 W3 W12 W11 W2 E16
E14 SE28
W8 SE1
W14 SW1 SE16
SW7 SE10
W6 SW5 SE2
SW3 SE11 SE17 SE8 SE7
W4 SE18
SW
10
SW8 SE14
SW13 SW6 SE5 SE15 SE3
SW11 SW9
SW14 SE4
SW4 SE13
SE24 SE22
SW15
SW18 SW2 SE12 SE9
SW12
SE23
SE21 SE6
SW17 SE27 SE26
SW19
SW16 SE19
SE20
SW20
SE25
High-risk samples should be clearly labelled and packed separately from other samples.
TDL’s couriers cannot transport samples containing Hazard Group 4 Pathogens such as Ebola Fever
or Viral Haemorrhagic Fever.
6
Helpful information
The Laboratory Guide is designed to give you an easy-to-use reference for the most regularly requested
services, pathology profiles and tests. If you are not able to find details for tests and services, please
contact the laboratory on 020 7307 7373. We continue to develop a wide range of test and patient
services and our aim is to offer commitment to customer service, strong working relationships and
help and support for referring doctors and their practices.
For details about all services, please contact the laboratory on 020 7307 7373,
or for more information visit www.tdlpathology.com.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
of collection. Turnaround times are quoted as working days. 7
Helpful information
SEMEN ANALYSIS
Semen samples need specialist handling within the laboratory. For this reason all requests for
Semen Analysis must be made by appointment. Practices or patients can make an online appointment
at www.tdlpathology.com/andrologybooking or call 020 7025 7940 to make appointments and
confirm instructions for sample collection. There is an attendance fee of £45.00.
1 Patients must abstain from ejaculation for at least 2 days but not longer than 5 days
before the test.
2 Ideally semen samples should be produced at The Doctors Laboratory, 76 Wimpole Street,
unless there are exceptional circumstances. In these exceptional circumstances please
contact TDL Andrology on 020 7025 7940 for special arrangements and instructions.
Refer to Andrology, see page 62.
Semen Analysis services are not provided in Manchester.
If additional tests are required for a sample already received please contact the laboratory on 020 7307
7373 with your request for specific further analysis. Samples are stored within timeframes according to
their discipline. Laboratory staff will advise on the ability to undertake further testing from samples already
received in the laboratory.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
8 of collection. Turnaround times are quoted as working days.
Helpful information
EMAILED REQUESTS FOR ADD ONS
The majority of samples received in the laboratory are kept for one week. If sample type and
volume allow, further testing can be requested by telephone on 020 7307 7373 or by email to
[email protected]. Please specify the details of the test(s) details to be added;
Patient details and LABORATORY NUMBER also need to be given with emailed requests.
HOME VISITS
This service is available for patients who, for whatever reason, prefer samples to be taken at home
or at locations other than a doctor’s practice or TDL’s Patient Reception at 76 Wimpole Street, London.
This is a service that is used regularly to save time for both doctors and patients and ensures that
results can be made available before consultation is undertaken.
There is a visit fee from £120.00 to patients within the M25, and from £160.00 for children when two
nurses are needed. Home visits outside the M25, for weekends, bank holidays and night fees are by
special arrangement. To arrange a Home Visit please telephone Patient Reception on 020 7307 7383
or email [email protected].
SAMPLE PACKING
Samples need to be transported for subsequent processing and testing. Transport systems will be various
and cover both long or short distances.
Samples need to be collected and packed into appropriate sample containers provided by the laboratory in
order to maintain integrity of the sample(s). Attention needs to be given to temperature, special transport
containers and time limitations.
Clinics, practices and laboratories who are posting or transporting samples by air, sea, rail and road
between local, regional and reference laboratories, or between laboratories in other countries,
must adhere to a number of regulations. These regulations are designed to deal with transportation
accidents and spills, reduce biohazards and keep samples intact for testing.
Regulations are given by several sources including
• National transport regulations • IATA
• Rail and road traffic agencies • Postal services
Compliance is mandatory in order to reduce risk to couriers, carrier, laboratory staff and passengers.
Sample transport requirements are based on the category of samples being transported.
Infectious substances are classified as Category A or Category B.
TDL does not arrange for transport of Category A samples (infectious substances capable of causing
permanent disability or life-threatening or fatal disease to humans or animals).
Instruction and packaging for Category B is provided, covering Biological Substances, UN number UN 3373.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
of collection. Turnaround times are quoted as working days. 9
Helpful information
PACKAGING REQUIREMENTS
There are specific packaging instructions and labelling requirements requiring triple packaging.
1 Primary leak-proof container – tube or vial containing the sample must be placed
inside a ziplock specimen bag with absorbent material
2 Secondary watertight container, with absorbent material, intended to protect the primary container
3 Outer container protects the secondary container.
There are specific packaging instructions for frozen samples requiring shipment using BioFreeze bottles,
or Dry Ice.
For information please contact the Referrals Dept ([email protected])
POSTAL PATHOLOGY
Postal pathology services should be considered by all practices in the UK who need a rapid
delivery service to the laboratory. Changes with Royal Mail mean that ALL pathology postal packs
are now made up with Tracked 24 returns. This provides a particularly suitable method of transport
for any healthcare organisation. Postal pathology with Tracked 24 returns provides:
• Simple and convenient sample handling throughout the UK for most tests.
It is not suitable for microbiology or coagulation samples
• Scope for large and small numbers of samples
• Next morning delivery
• Allows patients and practices to track samples through the Royal Mail system
• Samples can be posted from any Royal Mail post box, including COVID-19 antibodies
• Designated Priority boxes for COVID-19 PCR (swab) kits
• There is a charge of £2.26 for each Royal Mail Tracked 24 pack. This charge
will be itemised in monthly invoices to the practice or patient, as requested.
DX SYSTEM
DX is a well known next-day courier of Category B specimens – transporting biological samples
in compliance with the industry’s highest regulations. DX is compliant to IATA regulations,
is audited independently by Dangerous Goods Safety Advisors. They work with a combination
of large health organisations and smaller, independent laboratories to ensure the safe delivery
of specimens every year.
TDL’s DX Address is DX 340201, St Pancras 90 WC.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
10 of collection. Turnaround times are quoted as working days.
Helpful information
REQUESTING AND REPORTING OPTIONS
We continually review and update our IT Services for receiving requests and reporting results
electronically between practices and the laboratory. A number of innovative report formats
are now available.
• Encrypted Email
Results will be sent in encrypted format to any number of predetermined email addresses.
Copy reports will be emailed automatically to email addresses on the system.
• Link to Practice Management System
Bidirectional requests and results can be delivered electronically to a number of integrated practice
systems. Practice software that accepts data in an HL7 format can be linked to receive results
from the laboratory.
All TDL systems are accredited to the latest International Standard for Information Security
ISO/IEC 27001:2013.
• TDL e-View
Registered users can view all their results online. This is a secure Login/Password protected
look-up system, with a cumulative results reporting function. Results can be accessed any time,
from anywhere, through the internet.
• Printed Copy
Results are posted out on the day they are reported.
• TDL Portal
This provides the most accurate option for clinics without a practice management system.
For information about this option please contact [email protected].
TDL WEBSITE
The TDL website at www.tdlpathology.com gives updated details of our tests – sample types,
turnaround times and special instructions. The Specialities section provides a new way to find tests
you need, and a Services section has additional information for TDL Collect, Postal Pathology
and TestGuide app. Reference Ranges are given on the website or can be requested by emailing
[email protected]. Full details of our tests and profiles are also available in the
TDL TestGuide app (see page 12).
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
of collection. Turnaround times are quoted as working days. 11
Helpful information
TDL TESTGUIDE APP
Available for iOS and Android, the TDL TestGuide app offers:
• Full details of TDL’s tests and profiles
• The TDL Pathology Handbook, which provides information on more than 1000 pathology topics,
reflecting our deep collective knowledge across all areas of pathology
The app can be downloaded from the Apple App Store or Google Play Store. To register for the app, you
will just need your TDL Source Code and an email address. Please contact [email protected]
if you need help with finding your Source Code.
Feedback for the TestGuide app and Pathology Handbook and is always welcome; please send
suggestions and comments to [email protected].
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
12 of collection. Turnaround times are quoted as working days.
Helpful information
WHO TO ASK FOR HELP
24 hour Telephone (main switchboard / all services): 020 7307 7373
CEO David Byrne [email protected]
Group Commercial Director Brian Madden [email protected]
Group Laboratory Director Tim Herriman [email protected]
Director of Sales / Service Annette Wilkinson [email protected]
Director of Genetics Dr Lisa Levett [email protected]
& Molecular Pathology
Chief Information Officer (IT) John Matthews [email protected]
TDL MANCHESTER
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
of collection. Turnaround times are quoted as working days. 13
Quality assurance
The Doctors Laboratory is committed to providing doctors with pathology of the highest quality.
The quality of results is of fundamental importance and the laboratory operates to stringent technical
and administrative standards.
Internal quality assurance is achieved by strict adherence to standard operating procedures for all
analytical processes. TDL participates in recognised National External Quality Assessment Schemes.
These schemes are subscribed to by NHS and private laboratories. Results are subjected to strict
internal and external quality control. Details of the laboratories to whom TDL refers specialist testing are
available from TDL Referrals. These laboratories are UKAS accredited or of equal accreditation status.
Details of the tests that are referred are given on the TDL website. QA is administered by TDL’s Quality
Management Group (QMG) who also adhere to regulatory and accreditation requirements.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
14 of collection. Turnaround times are quoted as working days.
Quality assurance
Toxoplasma IgG Serology Cystic Fibrosis
Trace Elements Duchenne / Becker Muscular Dystrophy
Urine Chemistry Hereditary Haemochromotosis (C282Y+H63D)
Vitamin D (25 OH) genotyping + reporting
HLA Class I (HLA-A, HLA-B, HLA-C)
HAEMATOLOGY: UKNEQAS for Tissue Typing (low resolution)
Automated Differential Leucocyte Count HLA Class II (HLA-DRB1, HLA-DQB1)
Blood Film Morphology Tissue Typing (low resolution)
Coagulation (Including PoCT Coagulation) HLA-B27 Genotyping
EBV Mononucleosis HLA-B57*01 Genotyping
ESR and NRBC (nucleated Rbc) HLA+ Disease Typing
Flow Cytometry Cytochrome P450 2D6 / 2C19 genotyping
Leukaemia immunophenotyping Human Papillomavirus DNA
Myeloperoxidase Mature B & T cell Neoplasms –
Iron stain FISH for CLL and Lymphoma
Full Blood Count Mature B & T cell Lymphoma – G-banding
Haematology Myeloid (AML/MDS/CML) – G-banding and FISH
Haematology Analysis Myeloma – sample FISH set up
Malaria and analysis plus online
Parasite Films NGS AML gene panel
Reticulocyte NIPT for aneuploidies
Sickle Screening NIPT for sexing
Thrombophilia Screening Paternity Testing
Blood Transfusion Laboratory Practice Scheme (BTLP) Prader-Willi and Angelman Syndromes
QF-PCR Aneuploidy Detection
Factors assays: Sexually Transmitted Diseases (CT/NG/MGEN/TV)
Von Willebrand (vWD) screen
Spinal Muscular Atrophy
Anti-Xa assays
Thrombophilia (Factor II, V, MTHFR)
Plasma viscosities
Y Microdeletion PCR Assay
ADAMTS-13 activity
ADAMTS-13 antibody MOLECULAR VIROLOGY
Heparin / Platelet Factor 4 Induced Antibodies Atypical Mycobacterium
Platelet function analysis (RCPA) Adenovirus DNA Viral load
Lupus anticoagulant: Bacterial 16S
Taipan Venom Time B19 virus DNA Viral load
DRVVT assay BK virus DNA Viral load
CMV DBS (dried blood spots)
GENETICS AND MOLECULAR VIROLOGY
CMV DNA Plasma Viral load
MOLECULAR GENETICS
CMV DNA Whole Blood Viral load
Acquired array (CLL/MDS)
CMV Resistance
Acute Leukaemia FISH pilot
EBV DNA Plasma Viral load
Acute Lymphoblastic Leukaemia (ALL)
EBV DNA Whole Blood Viral load
– G banding and FISH
Enterovirus RNA
BoBs Rapid Aneuploidy detection
Gastroenteritis Virus Panel
Chlamydia & Gonorrhoea detection by PCR
Hepatitis B Genotyping
Constitutional Clinical Cytogenetics
Hepatitis B Drug Resistance Typing
(Rounds for Amniocentesis, CVS,
Solid Tissue, Blood, Array CGH) Hepatitis B Viral Load
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
of collection. Turnaround times are quoted as working days. 15
Quality assurance
Hepatitis C genotyping Cryptococcal antigen
Hepatitis C Resistance genome detection (NS5a & b) Fungal culture
Hepatitis C Resistance Typing (NS3 & NS5a) Fungal biomarkers
Hepatitis C Viral Load Urinary antigen
Hepatitis D Virus Viral load and Qualitative PCR
WEQAS POCT:
Hepatitis E Virus Viral load and Qualitative PCR
Urinalysis
HIV-1 Drug Resistance (Pol)
HIV-1 Drug Resistance (Integrase) QCMD:
HIV-1 RNA Viral load Dermatophyte PCR
HIV-1 RNA Qualitative PCR PCP PCR
HIV-1 Tropism Genome Detection Atypical pneumoniae PCR
HIV-2 Viral load and Qualitative PCR
HSV 1&2 DNA IMMUNOLOGY
HSV Drug Resistance UKNEQAS – General Immunology for:
Human Herpes virus 6 DNA Allergen Component Testing
Influenza Haemagglutinin typing Autoimmune Serology ANCA/GBM Antibodies
JC virus DNA Bullous Dermatosis Antibodies
Measles and Mumps PCR Allergen Specific IgE Antibodies
MERS Coronavirus General Autoimmune Serology
Parechovirus RNA Anti-Phospholipid Antibodies (ACAB)
Respiratory panel I Nuclear and Related Antigens
Respiratory panel II IGRA TBQ
SARS-CoV-2 (COVID-19) PCR/NAAT Intrinsic factor
SARS-CoV-2 (COVID-19) antibodies Islet Cell Antibodies (Diabetic Marker)
Syphilis PCR Myositis Antibodies
Transplantation Virus Panel Specific Microbial Antibodies
VZV DNA C1 Esterase inhibitor and functional complement
Syphilis (TPPA and RPR)
MICROBIOLOGY Lyme (IgG and IgM)
Laboratory Quality Scheme: Hepatitis C
Helicobacter pylori antigen from faeces Hepatitis E (IgG and IgM)
Polarising crystal microscopy from synovial fluid Coeliac Disease (Endomysium, Tissue transglutaminase)
Streptococcus pyogenes (Group A) detection
in pharyngeal samples EUROQAS:
Surveillance for multi drug resistant bacteria Liver Blot
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
16 of collection. Turnaround times are quoted as working days.
Quality assurance
RCPAQAP Scheme: CERVICAL SCREENING:
Brucella Serology PHE:
Legionella (IgG) Serology Gynaecological Cytopathology EQA Scheme (GEQA)
Scleroderma Antibodies National EQA Scheme for the Preparation and Staining
Striated Muscle Antibodies of Cervical Liquid Based Cytology Samples (TEQA)
Chlamydia Serology
HOLOGIC:
INSTAND Scheme:
ThinPrep Stain EQA
Adrenal Antibodies
Hepatitis E Serology UKNEQAS for Microbiology
RNAP Antibodies
Molecular Detection of HPV
CSCQ Scheme:
DIAGNOSTIC CYTOLOGY
Lyme Serology
UKNEQAS for CPT:
Laboratory Quality Scheme: Stained Non-Gynaecological Cytology Module.
Herpes Simplex Virus All non-gynaecological (diagnostic cytology),
Cytomegalovirus including Urine Cytology, are referred to a UKAS
Antistreptolysin O Titre accredited laboratory for reporting.
Helicobacter Pylori IgG Antibodies
RNA Polymerase III ANDROLOGY: UKNEQAS for
Euroimmun ifW-Lubeck Liver Autoimmune Disease Scheme Semen Analysis Scheme
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
of collection. Turnaround times are quoted as working days. 17
Quality assurance
LINKS TO THE UKAS SCHEDULES OF ACCREDITATION
(Certain UKAS accreditations can be found under Health Services Laboratories (HSL),
which is part of the TDL Group of Laboratories.)
HSL Blood Sciences (8169)
https://www.ukas.com/wp-content/uploads/schedule_uploads/00007/8169%20Medical%20Single.pdf
HSL Infection Sciences (8860)
https://www.ukas.com/wp-content/uploads/schedule_uploads/00007/8860%20Medical%20Single.pdf
HSL Molecular Pathology and Genetics (8059)
https://www.ukas.com/wp-content/uploads/schedule_uploads/00007/8059%20Medical%20Single.pdf
TDL Manchester (8812)
https://www.ukas.com/wp-content/uploads/schedule_uploads/00007/8812%20Medical%20Multiple.pdf
TDL Andrology (10199)
https://www.ukas.com/wp-content/uploads/schedule_uploads/00007/10199%20Medical%20Single.pdf
HSL Cytology (8511)
https://www.ukas.com/wp-content/uploads/schedule_uploads/00007/8511%20Medical%20Single.pdf
TDL Urine Cytology (9706)
https://www.ukas.com/wp-content/uploads/schedule_uploads/00007/9706-Medical-Multiple.pdf
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
18 of collection. Turnaround times are quoted as working days.
Quality assurance
MEASUREMENT UNCERTAINTY
Medical laboratories are responsible for ensuring that test results are fit for clinical application by
defining analytical performance goals and selecting appropriate measurement procedures. All types
of measurement have some inaccuracy due to bias and imprecision; therefore measurement results
can only be estimates of the values of the quantities being measured. To properly use such results,
medical laboratories and their clinical users need some knowledge of the accuracy of such estimates.
The complete result of a measurement is a value, a unit and an estimate of uncertainty. This estimate
of uncertainty is conventionally referred to as Measurement Uncertainty (MU) and incorporates the
cumulative range of factors involved in the testing procedure itself in addition to consideration of the
inter-individual and intra-individual biological variation which will potentially influence the overall test
result. Evaluating measurement uncertainty is an ISO 15189:2012 accreditation requirement.
In terms of MU determined by the TDL / HSL group of laboratories, it should be noted all assays are
performed in strict accordance with the manufacturers’ instructions. MU, which has been estimated for
each assay during the verification procedure, is reviewed at regular intervals to ensure that MU values do
not exceed the pre-defined maximum allowable uncertainty for each assay. Overall assay performance
is also regularly monitored through internal quality control (IQC) and external quality assessment (EQA)
schemes and incorporated in test result interpretation. MU for individual assays is available upon request.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
of collection. Turnaround times are quoted as working days. 19
Quality assurance
• Sample contamination (e.g. being in the same bag as a leaking sample).
• Samples are high risk or infectious.
• Samples that are received in expired tubes.
Department Specific
• Sample Reception will not accept samples packaged with needles of any kind.
• Haematology cannot accept frozen whole blood for testing.
• Coagulation cannot accept over or under filled samples for testing.
• Coagulation cannot accept previously frozen samples that have thawed in transit.
• Biochemistry cannot accept previously frozen samples that have thawed in transit.
• Biochemistry cannot accept samples that display antibody interference.
• Biochemistry cannot accept samples that have had separation delays/un-centrifuged
samples that have been stored in the fridge.
• Biochemistry cannot accept paraprotein resulting in viscous samples.
• Biochemistry cannot accept CSF protein that is blood stained.
• Immunology cannot accept TBQ kits that:
• Do not contain all of the appropriate tubes.
• Are incubated for more than the specified 16 hours.
• Have passed the incubation time period.
• Are over or under filled.
• Microbiology cannot accept samples in non-sterile containers or in formalin.
• Referrals cannot accept samples without three points of identification for DRP testing.
• Referrals cannot accept samples that are not labelled by hand for blood group testing.
• Molecular Pathology cannot accept samples for Haemophilia testing without informed consent.
• Cervical Cytology cannot accept over or under filled samples for testing.
• Cervical Cytology cannot accept samples received within three months of the previous test
in order to allow epithelial cells to regenerate.
• Urine cytology cannot accept delayed samples unless they have been refrigerated.
Samples deemed to be PRECIOUS (e.g. CSF, fluid, tissue, bone marrow and paediatric samples) will not
be discarded by the laboratory. Results will include a comment relating to the condition of the sample
(e.g. sample unlabelled).
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
20 of collection. Turnaround times are quoted as working days.
Quality assurance
CONSULTANT ADVICE AND OPINION
Each department in the laboratory is consultant led. The TDL doctors Consultants listed below
have defined areas of cover and so for doctors wanting clinical advice or professional support,
TDL consultants can be contacted via the laboratory.
TDL CONSULTANTS
ALLERGY AND IMMUNOLOGY Dr Bernie Croal Dr Mayur Patel
Dr Scott Pereira MB, ChB, BSc Hons, MSc, MD, MB, BS, FRCPath
MA, MB, B Chir, PhD, FRCPath FRCP, FRCPath, CSci, EuSpLM
Dr Michael Thomas
Professor Suranjith Dr Denise Darby BSc, PhD, MSc, FRCPath,
Seneviratne MRCP, FRCPath EuSpLM, SRCS, CSci
DPhil (Oxon), FRCP, FRCPath Professor Carel le Roux Prof Pankaj Vadgama
FRCPath MB, BS, FRCPath
ANDROLOGY
Mr Craig Webster Dr Paul Holloway
Dr Sheryl Homa
FRCPath FRCPath
PhD, ARCS, FIBMS
Mr Ed Kearney Dr Paul Masters
BIOCHEMISTRY AND MSc, MCB, FRCPath MRCP, FRCPath
POINT OF CARE TESTING
Dr Jamie Alaghband-Zadeh Dr Peter Galloway
Dr Frank Geoghegan
FRCPath BSc, MB, ChB, MRCP, DCH, FRCPath
FRCPath
Mr Jim Allison Dr Rachel Webster
Dr Gilbert Wieringa
BSc Hons, FRCPath, CSci, EuSpLM PhD, FRCPath
MSc, FRCPath, EuSpLM
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
of collection. Turnaround times are quoted as working days. 21
Quality assurance
Dr Rajeev Srivastava Dr Mamta Sohail MEDICAL MICROBIOLOGY
MBBS, MS, FRCS, FRCPath, EuSpLm BM, BS, FRCPath Dr Robin Smith
Dr Mansour Ceesay FRCPath
BLOOD TRANSFUSION
AND HAEMATOLOGY FRCPath Dr Alistair Leanord
Dr Vivienne Andrews Professor Marie Scully FRCPath
FRCPath MRCP, FRCPath Dr Antonia Scobie
Dr Nick Jackson Dr Mark Vickers MBBS, BSc MSc, DTM&H,
MA, MBBS, MD, MRCP(UK), FRCPath MBChB, MCRP, DM, FRCPath MRCP(ID), FRCPath
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
22 of collection. Turnaround times are quoted as working days.
Special instructions for samples
1 Contact the laboratory for special sample tubes/ 20 Sample types: FCRU or PCR swab or TPV
containers/instructions. or Semen.
2 Confirmation of not negative drug screens by 21 Urine cytology container, ideally first catch,
LCMS/MS may take up to 5 days. mid-morning specimen.
3 Clinical history essential and protect from light. 22 Must be fresh.
4 Send to the laboratory without delay. 30 Collect sample at end of exposure.
5 Do not send sample to the laboratory between 33 Sample must be labelled by hand with first
Friday noon and Monday morning. name, family name, gender and date of birth
6 Contact the Referrals Department before taking detailed on sample and form. Do not use labels
and sending sample to the laboratory. other than the tube label.
7 Sample should be separated and frozen if 34 Samples must arrive in the laboratory on the same
sending overnight. day of sample taking or contact the laboratory.
8 DRP Form required. DRP Form can be found 35 Patient should be fasting and resting for 30 mins
at the back of the guide. before sample taking. Samples need handling
urgently.
9 Clinical history must be provided.
36 Renin: Sample collected either upright /active
10 Contact the laboratory for special stability tubes or resting /supine (3 hours lying).
for lymphocyte subsets – or take an EDTA sample
and ensure same day delivery to the laboratory, 37 Provide sample time and date of collection.
Monday to Friday noon (do not send sample 38 EDTA sample should not be separated:
between Friday noon and Monday morning). send whole blood.
11 Patient consent required. Consent Form can 39 Urgent samples have a 3 day TAT if genotype is
be found at the back of this guide. required for prenatal diagnosis or two weeks TAT
12 Please provide one sample for each person if urgent for other factors.
being tested. 40 Informed Consent is required for these tests.
13 Protect from light. 41 Recommendation for patient to attend
14 Provide details of travel history. Patient Reception for sample taking.
15 Ammonia 42 LGV can be added to a positive chlamydia sample
using the same swab if requested within 4 days
Sample: EDTA plasma only. Full tubes and tightly
of receipt of result.
stoppered. On ice, centrifuged and analysed
20-30 mins post venepuncture (or plasma can 43 Please contact [email protected]
be frozen). If haemolysed gives falsely high results. for details for referring samples to the laboratory
Patient: Fasting. Avoid smoking. for sequencing testing.
16 Lactate
Example of profile panel information
Sample: Fluoride oxalate plasma only.
On ice and separate from cells 15-30 mins,
analyse promptly. Handle with care as sweat Profile PRE-TRAVEL SCREEN (DVT)
contains large amounts of lactate. No tourniquet. name
Patient: Rest 30 mins prior to test. FBC
17 Homocysteine Profile Factor II Prothrombin Gene
content Factor V Leiden
Should be spun and separated with 1 hour
Anticardiolipin TAT
of venepuncture.
Turnaround
Antibodies 5
18 Citrate Samples DAYS
time
Samples should be double spun and separated
and frozen within 4-8 hours of sample taking, DVT1
if a delay is expected with transportation to Sample
AAB9 Code
the laboratory, samples must be transported requirements
as frozen. Reference to sample taking and
special handling instructions (see above)
19 Must include patient’s age, height and weight.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
of collection. Turnaround times are quoted as working days. 23
TDL Screening Profiles DL1–DL12
BIOCHEMISTRY
HAEMATOLOGY
DL1
BIOCHEMISTRY
DL2
(24 PARAMETERS) DL3 PROFILE
PROFILE & HAEMATOLOGY
PROFILE FBC with 5-part Diff TAT
BG ABG DL4
BIOCHEMISTRY plus
GENERAL WELL
DL5 & HAEMATOLOGY DL6 PERSON PROFILE DL4L HDL Cholesterol
LDL Cholesterol
POSTAL PROFILE Non-HDL Cholesterol
DL2
As DL4 FT4/TSH ABG
DL5/DL5L do not include ESR and Ferritin
Phosphate as these results
may be more affected by TAT TAT
overnight transit times. 4 4
HOURS HOURS
DL5 DL6
plus plus
HDL Cholesterol HDL Cholesterol
DL5L LDL Cholesterol DL6L LDL Cholesterol
Non-HDL Cholesterol Non-HDL Cholesterol
ABG ABG
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
24 of collection. Turnaround times are quoted as working days.
TDL Screening Profiles DL1–DL12
WELL MAN WELL PERSON SENIOR MALE
DL7 PROFILE DL8 PROFILE DL9M PROFILE 60+
ABBG RU QFIT 4
BB B B B C34
DL12
*** Do not refrigerate samples at any time. Samples must be received by TDL within 24 hours of taking the sample.
Please do not send samples to the laboratory on Saturdays. T-SPOT®.COVID test is CE marked.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
26 of collection. Turnaround times are quoted as working days.
Testing for COVID-19 (SARS-CoV-2)
Roche Elecsys Roche Elecsys Abbott Architect Abbott Architect
Anti-SARS-CoV-2 S Anti-SARS-CoV-2 SARS-CoV-2 IgG SARS-CoV-2 IgM
(Spike – detects Total antibody (does not detect (does not detect
vaccine) Total (does not detect antibodies from antibodies from
antibody antibodies from vaccine) vaccine)
vaccine)
Reporting Positive with value Positive / Negative Positive / Negative Positive / Negative
ranges reported in U/ml /
Negative
TDL reports all Antibody and PCR activity daily to the UK Health Security Agency (UKHSA). It is a statutory
requirement that laboratories notify this information and it is therefore essential that the patient’s address
and postcode are provided so that positive results can be followed by Test and Trace.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
30 of collection. Turnaround times are quoted as working days.
Biochemistry
TEST CODE SAMPLE REQS TAT
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
32 of collection. Turnaround times are quoted as working days.
Biochemistry
TEST CODE SAMPLE REQS TAT
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
34 of collection. Turnaround times are quoted as working days.
Biochemistry
TEST CODE SAMPLE REQS TAT
B B B
B AB9 ABG RU
AMI
B A: Myoglobin
20
Multiples of the AMI
C: CK-MB
5 C
2 A
1 AMI Decision Limit
D
URL (Upper Reference limit)
0
0 1 2 3 4 5 6 7 14
4 12 16
hrs hrs hrs Days after onset of AMI
Kinetic Characteristics for Chest Pain Markers
Beginning Peak Duration
Myoglobin 0.5–2 hours 5–12 hours 12–24 hours
Troponin T (hs) 3–4 hours 12–24 hours 14 days
CKMB 3–8 hours 10–18 hours 24–36 hours
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
36 of collection. Turnaround times are quoted as working days.
Biochemistry
BONE SCREEN
BONE SCREEN OSTEOPOROSIS SCREEN
(BLOODS ONLY)
B CU B BB
Cholesterol Cholesterol
Triglycerides Triglycerides
HDL Cholesterol HDL Cholesterol
LDL Cholesterol LDL Cholesterol
Non-HDL Cholesterol Non-HDL Cholesterol
Apolipoprotein A Apolipoprotein A
Apolipoprotein B Apolipoprotein B
Lipoprotein (a) Lipoprotein (a)
hsCRP Fibrinogen
Lp-PLA2 (PLAC) Test hsCRP
TAT Lp-PLA2 (PLAC) Test TAT
3 Homocysteine 3
DAYS DAYS
PP10 PP11
BB B B B C 34
TAT TAT
STAT 8 2
HOURS DAYS
B AG AG RU
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
38 of collection. Turnaround times are quoted as working days.
Haematology
SPECIAL HAEMOSTASIS
TEST CODE SAMPLE REQS TAT
FLOW CYTOMETRY
TEST CODE SAMPLE REQS TAT
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
40 of collection. Turnaround times are quoted as working days.
Haematology
HAEMATOLOGY PROFILE COAGULATION PROFILE 1 COAGULATION PROFILE 2
A C 18 A C 18
PROP ANTE
A A B C C C 18 A A 33 B B B G
# Please contact the Phlebotomy at Patient Reception 020 7307 7383 for further details, as needed.
Blood cultures must be taken prior to any other blood samples.
The aerobic bottle must be collected first, followed by the anaerobic bottle.
Each bottle should be filled with 8-10 ml of blood, use the markings on the bottles to achieve this.
• Other bloods can be collected but must be collected after the blood cultures.
• Bottles must be labelled with the patient’s identification details.
• Bottles and Request Form need to give the time taken and the body site that the blood was taken from.
Ensure that the bottle barcodes are not obscured when adding patient labels.
• Send the blood cultures to the laboratory without delay.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
42 of collection. Turnaround times are quoted as working days.
Microbiology
TEST CODE SAMPLE REQS TAT
Sample types:
VB1U: first-pass urine (pre-prostatic massage)
VB2U: mid-stream urine (pre-prostatic massage)
EPS: expressed prostatic secretion fluid
or
EPSW: expressed prostatic secretion fluid swab
VB3U: first-pass urine (post-prostatic massage)
PROS
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
44 of collection. Turnaround times are quoted as working days.
Microbiology
URINE CULTURE PROCESSING AND RESULTS
All urine culture testing is performed using manual methods. The culture pathway adheres to national guidance
and is a fully UKAS-accredited method.
Manual testing allows a larger amount of urine to be tested than previous automated method, which enables the
laboratory to detect lower bacterial counts (as low as 103 cfu/mL) and also facilitates the follow up of significant
organisms grown from mixed cultures.
If the culture result is indicative of urinary tract infection, antibiotic susceptibilities will be tested from the
culture growth and will be available 24 hours after the culture result. ‘Direct sensitivities’ are no longer performed.
Direct susceptibility testing is not inoculum-controlled, produces inaccurate results and is not UKAS-accredited.
Culture results should be interpreted alongside the microscopy WBC count and clinical signs and symptoms.
Significant growth on culture in the absence of pyuria may be suggestive of contamination with regional flora
rather than true infection. It should be noted, however, that WBC degrade in urine quite rapidly and delays between
sample collection and microscopy may lead to falsely low WBC readings which may account for these findings.
The preservative reduces the overgrowth of organisms and, to a lesser extent, reduces the degradation
of white cells during transit leading to a more accurate laboratory result for both microscopy and culture.
UKAS recommends the use of boric acid containers for all urine sample for microscopy and culture
(Urine M,C&S) to improve the quality of microbiological results.
Red topped boric acid containers are for requests for urine microscopy and culture
(MC&S) ONLY. Boric acid container should NOT be used for:
• Other urine microbiology tests (e.g. investigations for Chlamydia, Mycobacterium,
Schistosomiasis, urinary antigen testing)
• Urine samples being analysed by PCR methodology
• Urine samples for non-microbiology tests (e.g. biochemistry, virology, pregnancy testing)
• Very small urine volumes (<20ml) e.g. neonates
Use of urinary dipsticks: boric acid may inhibit leukocyte esterase dipstick readings; dipstick testing
performed on a sample in a boric acid container should be interpreted with caution.
If additional tests are required in addition to urine microscopy and culture, an additional sample in
a white-topped universal container should be sent. In this case, it is advised that the mid-stream
clean catch urine is collected in a sterile bowl and then transferred to the necessary specimen containers.
If, despite these measures, a patient has recurrent mixed growth reports from multiple urines, it may suggest that
your patient has abnormal urinary tract architecture, immunosuppression or other non-infective cause that requires
different laboratory investigations or referral to a specialist. If further information is required, please telephone the
laboratory and ask to discuss the case with one of our consultant Microbiologists.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
46 of collection. Turnaround times are quoted as working days.
Microbiology
Swabs: Types and Codes
Patient Request Forms AND Swabs should be labelled with the body site from which the sample
was taken. This is important. The swab site determines the appropriate culture media required
to target the most likely pathogens.
SITE CODE SAMPLE TYPE
Culture Swabs
Candida Only Swab CANC Black or Blue Micro Swab
Cervical Swab CERS Black or Blue Micro Swab
Blue Micro/Transwab
Ear Swab EARS Blue or Orange Micro Swab are multipurpose, culture
Eye Swab EYES Blue or Orange Micro Swab swabs in transport medium
Gonorrhoea GONN Black Charcoal Swab
Orange Micro/Transwab
High Vaginal Swab HVS Black or Blue Micro Swab are small, thin wire culture
Nasal Swab NASS Blue or Orange Micro Swab swabs in transport medium
Oral Swab ORSW Black or Blue Micro Swab Black Charcoal
Penile Swab PENS Black or Orange Micro Swab Micro/Transwab
Rectal Swab RECG Black or Blue Micro Swab Wound, skin and urogenital.
Skin Swab SKIS Blue Micro Swab
Throat Swab THRS Blue Micro Swab
Urethral Swab URES Black or Orange Micro Swab
Vaginal Swab VAGS Black or Blue Micro Swab
Vulval Swab VULV Black or Blue Micro Swab
Wound Swab WOUS Black or Blue Micro Swab
RAPIDThis
Note: MRSAPCRby PCR MRSA Blue Micro Swab x 1 – state site
methodology uses MRS2 Blue Micro Swab x 2 – state sites
Blue Micro Swabs MRS3 Blue Micro Swab x 3 – state sites
MRS4 Blue Micro Swab x 4 – state sites
MRS5 Blue Micro Swab x 5 – state sites
Investigation of Investigation of
Superficial Fungal Infection Non-Superficial Fungal Infection
Sample type Nail, Hair, Skin. All specimens other than Skin, Hair and Nail.
72 hours for interim PCR report, and 7 days 7 days (non-sterile e.g. ear swab)
Turnaround
for final culture (unless the fungal culture and 3 weeks (sterile i.e. CSF).
time
needs to be extended for significant growth).
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
48 of collection. Turnaround times are quoted as working days.
Microbiology
STOOL FOR OCP
Sample Please request as OCP Comments
Type
Stool Requests for OCP only will include Overseas pathogens will only be tested if requested
testing for cryptosporidium and and travel history and clinical details are provided.
giardia by PCR
C. DIFFICILE DETECTION
Sample Please request as CLOS Comments
Type
Stool Serosep Enteric Bio PCR Change to PCR and Elisa methods.
Alere Techlab EIA (Toxin) Two tier PCR & Toxin c. diff screening based on PHE guidance.
Improved sensitivity and specificity for both targets tested.
Primary c. diff gene screening using Enteric Bio PCR.
Secondary sequential testing using Alere EIA to confirm Toxin.
Group B Streptococcus (GBS or group B Strep) is the most common cause of severe infection
in newborn babies, and of meningitis in babies under age 3 months. On average in the UK:
• 2 babies a day develop group B Strep infection
• 1 baby a week dies from group B Strep infection
• 1 baby a week survives group B Strep infection with long term disability
Most GBS infection is of early onset, presenting in babies within the first 6 days of life, and usually
within the first 12 hours after birth. Between age 7 days and 3 months, these infections are rare,
and in babies over 3 months they are very rare indeed.
Most early-onset GBS infections (in babies aged 0-6 days) can be prevented by giving intravenous
antibiotics in labour to women whose babies are at raised risk of developing GBS infection.
In the UK, women are offered IV antibiotics in labour based on specific risk factors.
GBS is normal flora of the distal GI tract. Up to 30% of women carry it harmlessly in their vaginal tract.
Vaginal carriage at the time of vaginal delivery can result in transmission of GBS to baby. Babies are
more vulnerable to infection as their immature immune systems cannot fight off the multiplying bacteria.
If untreated, GBS can cause serious infections, such as meningitis and septicaemia, which may lead
to stillbirths, and newborn and infant deaths. If they survive, babies can develop permanent problems
including hearing or vision loss, or cerebral palsy.
Current GBS prevention focuses on giving intravenous antibiotics to women in labour, aiming to reduce
disease in infants at delivery. 2 x Blue culture swabs (lower vaginal and lower rectal) should ideally
be taken from 35 weeks. Swabs will be placed in enrichment culture in the microbiology laboratory
to ensure maximal detection.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
50 of collection. Turnaround times are quoted as working days.
Endocrinology
TEST CODE SAMPLE REQS TAT
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
52 of collection. Turnaround times are quoted as working days.
Endocrinology
TEST CODE SAMPLE REQS TAT
Patients who have samples taken at TDL’s Patient Reception at 76 Wimpole Street may attend any time
during hours of opening on Mondays or Tuesdays, and by NOON on Wednesdays to allow for same day
shipping to Chicago by Fed Ex. Samples for Rosalind Franklin are not accepted on Thursdays, Fridays
or Saturdays. Fed Ex charges are included in these charges.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
54 of collection. Turnaround times are quoted as working days.
Endocrinology
REPRODUCTIVE IMMUNOLOGY AT
ST HELIER, CARSHALTON
TEST CODE SAMPLE REQS TAT
* Patients need to attend Patient Reception at 76 Wimpole Street by 11.00am latest Mondays –
Thursdays. Samples cannot be accepted on Fridays, Saturdays or Sundays. Allow 2 days for results.
FT4 T4 FT3
TSH TSH FT4
Free T3 TSH
Free T4
TAT Thyroglobulin Abs TAT TAT
4 Thyroid Peroxidase 2 4
HOURS DAYS HOURS
TF TF2 TF3
B B B
LH FSH DHEAs
FSH LH FSH
Prolactin Testosterone Testosterone
Oestradiol (17-Beta) Free Androgen Index Free Androgen Index
TAT TAT TAT
Prolactin LH
4 SHBG 4 SHBG 8
HOURS HOURS HOURS
B B BB
ERECTILE DYSFUNCTION/
ANTIMULLERIAN HORMONE (AMH PLUS)
IMPOTENCE PROFILE
Lipid Profile Age related reference Age Range Elecsys AMH
Glucose intervals in women (pmol/L)
HbA1C The reference intervals below
TSH 20 – 29 years 13.1 – 53.8
are derived from a population
Prolactin 30 – 34 years 6.8 – 47.8
of apparently healthy women
Total Testosterone not taking any contraceptive 35 – 39 years 5.5 – 37.4
Free Testosterone medication. The reference 40 – 44 years 0.7 – 21.2
PSA intervals represent the 10th –
SHBG 45 – 50 years 0.3 – 14.7
90th percentile values for the
Free Androgen Index women in each age bracket.
TAT TAT
3 4
DAYS HOURS
IMPO AMH
ABBG B Samples can be taken, at any time during a patient’s monthly cycle. Ambient, unspun
sample stability has been validated for up to 5 days. Postal samples are therefore
acceptable, and samples can also be collected and posted using TDL TINIES.
More Hormone Profiles
are shown on page 52
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
56 of collection. Turnaround times are quoted as working days.
Endocrinology
HRT PROFILE 1 HRT PROFILE 2 AMENORRHOEA PROFILE
B BG B
POLYCYSTIC OVARY
METABOLIC SYNDROME PROFILE PITUITARY FUNCTION PROFILE
SYNDROME: SHORT
Lipid Profile TSH Testosterone
Glucose FSH SHBG
HbA1C LH FAI
Insulin Prolactin FSH
hsCRP TAT Growth Hormone LH
Adiponectin 9 Cortisol Glucose
DAYS
Please provide details of time Insulin
METS of day sample is taken. Lipid Profile
TAT
Patient should be FT4/TSH
resting for 30 mins 4
ABBG before sample taking. TAT
HOURS
1 PCOS
DAY
MENOPAUSE PROFILE
PITF BG
FSH
LH
BB POLYCYSTIC OVARY
Oestradiol (17-Beta) SYNDROME PROFILE
TSH TAT FIRST TRIMESTER Testosterone A fasting
FT4 4 SCREENING BLOODS ONLY TSH 9.00am sample
HOURS (Risk to be calculated is recommended.
by requesting clinician) Glucose
MENO HbA1C
Free β-hCG FSH
B PAPP-A DHEAs
Free β-hCG and PAPP-A in serum and
Insulin
sonographic determination of nuchal LH
HIRSUTISM PROFILE translucency (NT) are markers of 17 Hydroxyprogesterone
choice to identify women at increased Lipid Profile
FSH risk of Down Syndrome during the first
Prolactin
LH trimester (week 11-13) of pregnancy.
Cortisol
Testosterone Antimullerian Hormone
DHEAs Androstenedione
TAT TAT TAT
SHBG
4 4 SHBG 5
HOURS HOURS DAYS
B B ABBBG7
PUBERTY
• FSH FSH
• LH Progesterone
• Progesterone
• Androstenedione
• DHEA sulphate
• Testosterone
• SHBG Day1 Day 14 Day 28
Menstruation Ovulation Menstruation
• Prolactin
Follicular Phase Luteal Phase
This cycle controls female fertility and is influenced by hormone levels which impact bone health and
many other aspects of female physiology. Pregnancy lasts 40 weeks and is divided into trimesters.
First Trimester (week 0–13): confirmation of pregnancy and associated tests may include:
• Pregnancy test (urine)
• Quantitated Beta HCG (serum)
• Ectopic Pregnancy assessment (Beta HCG and Progesterone)
• Recurrent Miscarriage Profile
• Antenatal Screen
• Nuchal Scan with Free Beta HCG and PAPP-A or Non-Invasive Prenatal Test (Harmony)
for risk assessment of Downs Risk (a DRP request form must be enclosed with samples,
see back of guide, and an image of the scan attached to the request form).
Contact TDL Genetics for details of Non-Invasive Prenatal Testing (NIPT)
• Chorionic Villus Sampling (CVS) for chromosomal analysis
(PCR for Rapid Trisomy and karyotyping for the rarer abnormalities)
• Toxoplasma/Varicella Zoster/Parvovirus/CMV
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
58 of collection. Turnaround times are quoted as working days.
Reproductive health
Second Trimester (week 14–26): Third Trimester (week 27–40):
testing is primarily directed at evaluating the testing for foetal wellbeing and the health
actual and potential development of the baby of the mother may include:
and may include: • Glucose and Protein (urine or serum)
• Downs Risk Profile (Triple Test +) • Toxoplasma
• Amniocentesis for chromosomal analysis • Atypical antibody screening
(AmnioPCR for Rapid Trisomy and karyotyping
• Group B Strep (From 35 weeks –
for the rarer abnormalities)
rectal and low vaginal swabs)
• Glucose and Protein (urine or serum)
• Chlamydia
INFERTILITY
Infertility and its management is increasingly implicated in growing numbers of clinical disciplines.
More recently, greater emphasis is being given to male infertility. Recent data suggests that approximately
40% of all infertility is ascribed entirely, or in part, to male factors, 40% to female factors with an
additional 20% unexplained. Testing at the outset of infertility treatment can reduce some of the
emotional and financial costs, as well as allowing couples to pursue other possible options.
• Hormones • Infection
• Lifestyle/Environmental • Chromosomes/Genetics
• Ovarian Reserve • Polycystic Ovary Syndrome
• Unexplained Infertility/Implantation failure • Recurrent/Spontaneous miscarriage
• Male Factors
AGEING
Reaching menopause and andropause is a gradual process with modulating hormones as ovarian
function declines in women, and the more gradual, less defined and highly variable effect in men.
Testing may include:
• Hormones (Menopause/Andropause Profile)
General patterns of age-related decline
• Testosterone/Free testosterone/
in estradiol levels in women (left)
Bioavailable Testosterone and total testosterone levels in men (right)
• SHBG
• DHEAs
• Thyroid function
• Osteoporosis/Bone Markers
HORMONES
FEMALE MALE
FSH – day 2/3 Testosterone/Prolactin/FSH/LH
LH Sex Hormone Binding Globulin
Oestradiol Inhibin B (male)
Antimullerian Hormone (AMH) Male Hormone Profile
Progesterone – day 21 Andropause Profile
Female Hormone Profile Insulin Resistance
Prolactin Erectile Dysfunction
Impotence Profile
INFECTION
FEMALE MALE
High Vaginal swab Investigations for prostatitis/urethritis
Cervical swab Mycoplasma Genitalium
Bacterial Vaginosis screen Ureaplasma
Toxoplasma Chlamydia/Gonorrhoea
Chlamydia/Gonorrhoea Chlamydia in Semen
CMV Hep B sAg/Hep B Core Abs/Hep C/HIV 1&2
Syphilis Herpes Simplex I/II by PCR
Hep B sAg/Hep B Core Abs/Hep C/HIV 1&2 Semen culture
Herpes Simplex I/II by PCR Syphilis
STI Profiles STI Profiles
Infection screening by PCR Infection screening by PCR
LIFESTYLE /ENVIRONMENT
FEMALE MALE
Well Person Profile DL6 Fit for Fertility Male Profile
Zinc, Lead Well Person Profile DL6
Trace Metal Profile (blood) Trace Metal Profile (blood)
Antioxidant Activity Antioxidant Activity
Thyroid Profiles Thyroid Profiles
Vitamin Profiles Vitamin Profiles
Vitamin D (25 OH) Vitamin D (25 OH)
Folate Folate
Selenium Selenium
Omega 3/Omega 6 Zinc
Omega 3/Omega 6
Oxidative Stress (ROS) in Semen
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
60 of collection. Turnaround times are quoted as working days.
Reproductive health
CHROMOSOMES/GENETICS
FEMALE MALE
Chromosome/Karyotype (parental) Chromosome/Karyotype (parental)
Fragile X (female) Male Hormone Profile
Cystic Fibrosis Screen Y-Chromosome microdeletion
Tay Sachs Fragile X Male
Carrier Screen (Ashkenazi Jewish) Screen Cystic Fibrosis Screen
Inherited disorders (specific) Tay Sachs
Carrier Screen (Ashkenazi Jewish) Screen
Inherited disorders (specific)
OVARIAN TUMOUR
FEMALE
Antimullerian Hormone (AMH) CA 125 / HE4
SPERM HEALTH
MALE
See TDL Andrology on page 62.
Appointments
It is important to make an appointment for all semen samples (on or off site) whether for
a comprehensive semen analysis or post vasectomy analysis. It may be necessary to give
patients who attend without an appointment a specific time to re-attend. The first appointments
for post vasectomy samples should usually be 12 weeks and 20 ejaculations after surgery.
Appointments can be made by calling 020 7025 7940. There is an attendance fee of £45.00
in addition to pathology charges.
Please complete a Pathology Request Form for your patient. If you would like to request other
pathology, you can use the same form or complete a second additional form. Results will usually
be reported to you within 48 hours.
If you would like to discuss these tests, or any aspect of this service including clinical interpretation by
the consultant please contact TDL Andrology on 020 7025 7940 or email [email protected]
for further information.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
62 of collection. Turnaround times are quoted as working days.
TDL Andrology
SEMEN
TEST CODE SAMPLE REQS TAT
Sperm Aneuploidy
Chromosomal abnormalities may be somatic cell in origin, in which case they can be detected by
a simple blood karyotype analysis. However, most sperm chromosome anomalies arise as a result
of errors during meiosis, which cannot be detected by a blood karyotype analysis. These anomalies
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
64 of collection. Turnaround times are quoted as working days.
TDL Andrology
can only be detected by looking at the sperm chromosomes directly. Studies have shown that sperm
with a high rate of aneuploidy have a negative impact on pregnancy rate and are associated with
recurrent pregnancy loss.
This test uses fluorescent in situ hybridisation (FISH) to label individual chromosomes with specific
probes. Hundreds of sperm are assessed from one ejaculate. There are limitations to the test as only
5 probes are currently used routinely for analysis (three of the 22 autosomes: chromosomes 13, 18
and 21, and the sex chromosomes, X and Y), although others are available upon specific request.
The results are reported showing incidence of disomy or nullisomy for each of the autosomes and
for both sex chromosomes. A sex chromosome ratio is also reported. It is CE marked.
References
Vassiliou A, Martin CH, Homa ST, Stone J, Dawkins A, Genkova MN, Skyla Dela Roca H, Parikh S, Patel J, Yap T, Killeen AP.
Redox potential in human semen: Validation and qualification of the MiOXsys assay. Andrologia. 2021 Mar;53(2):e13938.
doi: 10.1111/and.13938. Epub 2020 Dec 30. PMID: 33377541.
If you would like to discuss these tests, or any aspect of this service, please contact TDL Andrology
on 020 7025 7940 or 020 7307 7373, or email [email protected].
Semen samples need specialist handling – for this reason all requests for semen analyses should be
made by appointment. Practices or patients should contact TDL Andrology on 020 7025 7940 to make
appointments and to confirm instructions for sample collection.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
66 of collection. Turnaround times are quoted as working days.
Sexual Health
TEST CODE SAMPLE REQS TAT
7 STI Profile by PCR (7 tests from 1 Sample) PP12 FCRU / PCR / TPV 2 days
Chlamydia (PCR swab) SPCR PCR 2 days
Chlamydia (Thin Prep) TPCR TPV 2 days
Chlamydia (Urine) CPCR FCRU 2 days
Chlamydia/Gonorrhoea (PCR Swab) SCG PCR 2 days
Chlamydia/Gonorrhoea (Rectal) RSCG PCR 2 days
Chlamydia/Gonorrhoea (Thin Prep) TCG TPV 5 days
Chlamydia/Gonorrhoea (Throat) TSCG PCR 2 days
Chlamydia/Gonorrhoea (Urine) CCG FCRU 2 days
Chlamydia/Gonorrhoea/Trichomonas by PCR CCGT FCRU / PCR / TPV 2 days
CT/GC/Trichomonas/Mgen (PCR Swab) SGTM PCR Swab 2 days
CT/GC/Trichomonas/Mgen (Urine) CGTM FCRU 2 days
A 10mls or 2 x 4mls
Early Detection Screen PCR/NAAT STDX 3 days
(Vacutainer only)
Early Detection Screen PCR/
STXX B A 10mls or 2 x 4mls 3 days
NAAT with Syphilis
FASTest Sexual Health Screening Tests See page 71
Gardnerella vaginalis by PCR GVPC FCRU / PCR / TPV 2 days
Gonorrhoea (Culture) GONN CS ‡ ‡ ‡ 2-3 days
Gonorrhoea (PCR swab) SGON PCR 2 days
Gonorrhoea (Thin Prep) TGON TPV 2 days
Gonorrhoea (Urine) CGON FCRU 2 days
Haemophilus ducreyi by PCR DUCR PCR 7 days
Hepatitis A Profile HEPA B 4 hours
Hepatitis B Surface Antigen AUAG B 4 hours
Hepatitis C Antibodies HEPC B 4 hours
Herpes Simplex I/II by PCR (Swab) HERS PCR 5 days
Herpes Simplex I/II by PCR (Urine) HERD FCRU / PCR / TPV 5 days
HIV 1 & 2/p24Ag HDUO B 4 hours
HIV/HBV/HCV (Early detection by
STXX B A 10mls or 2 x 4mls 3 days
PCR/NAAT) with Syphilis
HIV/HBV/HCV Screen by PCR/ A 10mls or 2 x 4mls
STDX 3 days
NAAT (10 days post exposure) (Vacutainer only)
HIV Rapid RNA HIV-1 QUALITATIVE LHIV A (Vacutainer only) 4 hours
HIV Rapid RNA HIV-1 QUANTITATIVE RHIV A (Vacutainer only) 4 hours
HPV (DNA and reflexed mRNA) HPVT TPV 3 days
HPV (HR mRNA types 16, 18 + others) HPVH TPV 3 days
HPV (Individual low & high
HP20 TPV / PCR 3 days
risk DNA subtypes)
Lymphogranuloma Venerium (LGV) LGVP PCR* 42 1-2 weeks
Macrolide Resistance Test (Mgen) MGR FCRU / PCR 1-2 weeks
Mycoplasma genitalium by PCR MGEN FCRU / PCR / TPV 2 days
Mycoplasma genitalium/Ureaplasma by PCR MUPC FCRU / PCR / TPV 2 days
* LGV can be added to a positive chlamydia sample using the same swab if requested within 4 days of receipt of result.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
68 of collection. Turnaround times are quoted as working days.
Sexual Health
Chlamydia
Chlamydia is the most common curable STI diagnosed in the UK. Often asymptomatic, anyone who is sexually
active is considered to be at increased risk of chlamydia infection. It is the most commonly recognised,
screened and treated of all STI’s. Allow 6 weeks before re-testing to avoid picking up the DNA from
a previous infection.
Gonorrhoea
Gonorrhoea is caused by the bacterium Neisseria gonorrhea, which multiplies easily in the mucous membranes
of the male and female reproductive tract. It can cause serious and permanent health conditions if not treated.
Symptoms of gonorrhoea are usually overt in men with white, yellow, or green discharge from the penis.
Gonorrhoea can also infect the throat and rectum – individual PCR swabs from each site should be taken to
screen for gonorrhoea. Resistance to antibiotics is increasing and treatment is now combined oral and injectable
antibiotics. Partners should be treated at the same time with retesting after two weeks to confirm
clearance – test of cure is recommended following treatment for gonococcal infections.
M.gen can be requested as a single PCR test or with CT/GC, with or without other testing options. Important
updates to the UK BASHH M. genitalium management guidelines are taking the issue of antimicrobial resistance
seriously. The draft guidelines have been posted for consultation and include a grade 1B recommendation to
test for antimicrobial resistance, stating the importance of knowing the macrolide resistance status to determine
whether azithromycin should be prescribed. The guidelines aim to support laboratories in making a case
for increased funding to bring in the necessary testing to manage M. genitalium infections and associated
antimicrobial resistance.
Ureaplasma
U. Urealyticum and parvum are strains of bacteria that can lead to urinary tract infection and pelvic inflammation.
Usually asymptomatic, it is part of the normal genital flora of both men and women. It is found in about 70% of
sexually active humans. In males with lower sperm quality, ureaplasma infection could lead to a more pronounced
decreased in some seminal parameters and compromise sperm motility.
Gardnerella vaginalis
‘Gardnerella vaginalis is a bacterium rather than a sexually transmitted infection. It is part of the normal vaginal
flora but, when the normal balance of bacteria in the vagina is disrupted, it can flourish and overgrow leading
to bacterial vaginosis. Does it matter if it not an STI? Yes, because it can be characterised by a fishy smelling,
white vaginal discharge, itching, burning, and irritation, and there are some known pregnancy and pelvic
inflammatory conditions associated with Gardnerella as well as a higher risk of getting other STI’s.
In a patient with signs and symptoms suggestive of bacterial vaginosis detection of Gardnerella vaginalis
provides supportive evidence of bacterial vaginosis. It can, however, be detected in asymptomatic individuals
and it can also be absent in patients with bacterial vaginosis which has been caused by overgrowth of other
similar organisms such as Mobiluncus and Atopobium species. Results should be interpreted in line with
patient’s clinical symptoms and microscopy.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
70 of collection. Turnaround times are quoted as working days.
Sexual Health
FSSC FUSC
FSSS FSWS
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
72 of collection. Turnaround times are quoted as working days.
Sexual Health
EARLY DETECTION
INCUBATION PERIOD SAMPLE SITE
PROFILES BY PCR
7 STIs by PCR One sample for 7 STI Tests Urine
Cervix
Vagina
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
74 of collection. Turnaround times are quoted as working days.
Sexual Health
TEST TEST CODE SAMPLE TYPE TAT
Syphilis IgG / IgM SERJ B 4 hours
TAT TAT
2 4
DAYS DAYS
STD1 STD2
If culture swabs are needed please
B FCRU B FCRU request separately
TAT TAT
2 4
DAYS DAYS
STD3 STD4
TAT TAT
4 4
HOURS HOURS
STD5 STD6
B B
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
76 of collection. Turnaround times are quoted as working days.
Sexual Health
VAGINITIS / BV PROFILE SYMPTOMATIC LESION SAMPLE
STD8 USING CULTURE & PCR SWAB STD9 USING PCR SWAB FROM LESION
STD8 STD9
STDX STXX
TAT TAT
2 2
DAYS DAYS
MSM1 MSM2
B FCRU PCR Swab Throat PCR Swab Rectal B FCRU PCR Swab Throat PCR Swab Rectal
Sample must be received in the laboratory Sample must be received in the laboratory
within 24 hours of sample taking TAT within 24 hours of sample taking TAT
4 4
HOURS HOURS
LHIV RHIV
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
78 of collection. Turnaround times are quoted as working days.
Immunology
TEST CODE SAMPLE REQS TAT
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
80 of collection. Turnaround times are quoted as working days.
Immunology
TEST CODE SAMPLE REQS TAT
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
82 of collection. Turnaround times are quoted as working days.
Immunology
TEST CODE SAMPLE REQS TAT
* Please indicate clearly if samples have / have not been incubated prior to sending to the laboratory. If Lith Hep (green top)
tube is used, please request as TBQ4 and ensure sample is received in the laboratory within 16 hours of sample taking.
** If Tissue Transglutaminase (TAA) is regulated and is LOW (<0.2U/ml) total IgA will be reflexed. If total IgA is low (<0.1g/L)
deamidated gliadin IgG will be reflexed. If Tissue Transglutaminase (TAA) is HIGH (>10 U/ml), endomysial IgA will be reflexed
as confirmatory test.
*** Do not refrigerate samples at any time. Samples must be received by TDL within 24 hours of taking the sample. Please do
not send samples to the laboratory on Saturdays. T-SPOT®.COVID test is CE marked
GLUTEN SENSITIVITY
EVALUATION COELIAC DISEASE PROFILE 2 GLUTEN ALLERGY PROFILE
(COELIAC DISEASE ANTIBODY)
B AB ABB
* To reduce the risk of missing IgA deficient patients, a Total IgA will be run for all low Tissue
Transglutaminase IgA results.
If IgA deficiency is identified, a reflex deaminated Gliadin IgG will be carried out to determine whether
the patient is likely to have coeliac disease.
Coeliac pathway:
1 Initial TTG IgA samples are received and tested
2 If TTG IgA is LOW <0.2 U/ml reflex testing for Total IgA will be undertaken
3 If Total IgA is LOW <0.1 g/L then reflex testing for Gliadin IgG test will be undertaken
4 If TTG IgA is HIGH (>/= 10 U/ml then reflex testing for Endomesial IgA will be undertaken
as a confirmatory test.
Endomysial IgA
• This is no longer available as a stand-alone test. If requested the request will default to TTG IgA.
• However if TTG IgA is positive endomysial IgA will be carried out as a confirmatory test.
This only needs to be done once in the patients history.
Endomysial IgG requests
• No longer available as a single test request.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
84 of collection. Turnaround times are quoted as working days.
Immunology
Deamidated gliadin IgA requests
• This is no longer available. If requested the request will default to TTG IgA.
Deamidated gliadin IgG requests
• This can be requested as an individual standalone test as well as being incorporated
into the coeliac pathway. This may be useful when testing children’s samples.
Appropriate clinical comments will be added to results automatically – as follows:
Coeliac Disease (CD) is an immune-mediated disease of the intestines that is triggered by the ingestion
of gluten in genetically susceptible individuals. Gluten is the major protein component of wheat, rye,
and barley. Genetic predisposition does play a key role in CD, and it is well known that CD is strongly
associated with specific HLA class II genes known as HLA-DQ2 and HLA-DQ8. Approximately 95% of
CD patients express HLA-DQ2, and the remaining patients are usually HLA-DQ8 positive. The negative
predictive value for both tests is higher than 99%. However, the HLA-DQ2 allele is common and is carried
by approximately 30% of Caucasian individuals. Thus, HLA-DQ2 or HLA-DQ8 is necessary for disease
development but is not sufficient for disease development; its estimated risk effect is only 36-53%.
Note: History taking is important if a patient has been on a gluten-free diet for 6-12 months,
approximately 80% will lose their antibody response. After 5 years this increases to >90%.
RH RH3 RH5
AB AB AABB
RHEUMATOLOGY RHEUMATOLOGY
PROFILE 2 PROFILE 4 RHEUMATOLOGY
PROFILE 6
General screen for Systematic Lupus
Rheumatoid Factor
Connective Tissue Disorders Erythematosus
FBC FBC RF
ESR ESR Anti CCP Antibodies (RF)
Uric Acid Antinuclear Autoantibodies C Reactive Protein
Antinuclear Autoantibodies Anti-dsDNA IgG
Anti-dsDNA IgG Antibodies to Extractable TAT
Antibodies to Extractable Nuclear Antigens (ENA) 2
Nuclear Antigens (ENA) Anti nRNP DAYS
Anti nRNP Anti Sm
Anti Sm Anti Ro (SS-A) RH6
Anti Ro (SS-A) Anti La (SS-B)
Anti La (SS-B) Anti Jo-1 B
Anti Jo-1 Anti Scl 70
Anti Scl 70 Anti CENP
RHEUMATOLOGY
Anti CENP RF PROFILE 7
RF Anti CCP Antibodies Sjogren’s Syndrome
Anti CCP Antibodies Anti Cardiolipin Autoantibodies
HLA B27 Complement 3,4 Anti RO (SS-A)
C Reactive Protein C Reactive Protein Anti La (SS-B)
CENP-B Salivary Antibodies (SAB)
C Reactive Protein
TAT TAT TAT
3 2 10
DAYS DAYS DAYS
AABB ABB B
Patients with Irritable Bowel Syndrome (IBS) may benefit by testing for Calprotectin, see page 79 for details.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
86 of collection. Turnaround times are quoted as working days.
Immunology
CHLAMYDIA SPECIES SPECIFIC
AUTOANTIBODY PROFILE I AUTOANTIBODY PROFILE II
(MIF) ANTIBODY SCREEN
Thyroid Peroxidase Antibodies Thyroid Peroxidase Antibodies Chlamydia trachomatis
Antinuclear Antibodies Islet Cell Antibodies (serovar A-K & L1-L3)
Mitochondrial Antibodies Adrenal Antibodies Chlamydia pneumoniae
Smooth Muscle Antibodies Gastric Parietal Cell Antibodies Chlamydia psittaci
Gastric Parietal Cell Gonadal (Ovarian/
Antibodies Testicular) abs
LKM TAT TAT TAT
2 2 2
DAYS DAYS DAYS
B B B
FAECAL CALPROTECTIN CHRONIC FATIGUE
ELASTASE PROFILE SYNDROME PROFILE
Faecal Calprotectin Epstein-Barr Virus
Faecal Elastase Antibody Profile
Lymphocyte Subsets (CD4/CD8)*
CRP
Vitamin D (25 OH)
TAT TAT
5 5
DAYS DAYS
CEP VIP1
RF A + B 10
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
88 of collection. Turnaround times are quoted as working days.
Tropical and travel-related immunology
TROPICAL SCREEN POST-TRAVEL SCREEN 1 POST-TRAVEL SCREEN 2
(from 6 weeks post-travel) (Prior to 6 weeks) (Prior to 6 weeks)
Amoebic Antibodies Haematology Profile Haematology Profile
Schistosomal Antibodies Biochemistry Profile Biochemistry Profile
(Bilharzia) Schistosome Abs Schistosome Abs
Echinococcus Antibodies (Hydatid) Malarial Abs Malarial Abs
Leishmania Antibodies Hep A IgM Abs
Malarial Antibodies (IFA) Hep B sAg
Toxoplasma Antibodies IgG Hep C Abs
Toxoplasma HIV Duo
TAT TAT TAT
Antibodies IgM
10 10 10
DAYS DAYS DAYS
EORD
RF
often develops a ‘bulls-eye’ appearance. Many also develop flu-like symptoms with aching joints
and
muscles. The disease can later affect the nervous
system, joints and other body systems.
Borrelia Antibodies IgM (BORM):
detectable after 2-3 weeks
Borrelia Antibodies IgG/IgM
(BORR): detectable after several
weeks increasing to maximum at
4-6 months and may remain at
high levels for many years.
Borrelia Confirmation
(Immunoblot) (BORC):
The ELISA test is sensitive but
has a well-documented high
false positive rate giving positive
results in cases of glandular
fever, rheumatoid arthritis and
other autoimmune conditions.
If the ELISA is positive testing by
Immunoblot confirms a diagnosis
by Lyme disease. IgM and IgG
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
90 of collection. Turnaround times are quoted as working days.
Virology
IMMUNE STATUS
TEST CODE SAMPLE REQS TAT
Hepatitis B Immunity/Vaccination
NEEDLE STICK INJURY PROFILE
Anti HBs
(Donor – Not recipient)
less than 10 mIU/ml Non-immune to Hepatitis B Hep B sAg
Hep C Abs
10 – 50 mIU/ml borderline – Booster indicated HIV 1+2 Abs/p24 Antigen
TAT
Serum saved for 2 years
50 – 100 mIU/ml low level immunity – Booster suggested
4
HOURS
BB
Whole blood can be stored at 2°C to 30°C and must be centrifuged within 24 hours of specimen collection.
Separate the plasma or serum from the pelleted red blood cells following the manufacturer’s instructions
for the tube used. Plasma or serum can be tested on the Panther system in the primary tube or transferred
to a secondary Aptima Specimen Aliquot Tube (SAT) for testing on the Panther system. If not tested
immediately, plasma and serum can be stored in accordance with the specifications below. If transferred
to the SAT, plasma may be frozen at -20°C or -70°C, and serum may be frozen at -20°C. Do not freeze
specimens in EDTA, ACD, or serum primary collection tubes.
After centrifugation: In the primary collection tube at 2°C to 8°C for up to 3 days
In the Aliquoted Tubes: at 2°C to 8°C for up to 5 days
In the Aliquoted Tubes: at -20°C or -70°C for up to 90 days
B B B
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
92 of collection. Turnaround times are quoted as working days.
Virology
All virology samples are processed as per HBV Viral Load (DNAB)
manufacturers sample requirements and guidelines. This assay measures the concentration of Hepatitis B
viral DNA in patient serum. The test enables the viral
Hepatitis virus is named in order of their discovery
load at the beginning of treatment to be established
A, B, C, D, E and G.
and, thereafter, monitored to indicate treatment
Hepatitis A success.
Hepatitis A is spread through food and water that
have been contaminated with the virus derived from HBV Genotyping (BGEN)
human faeces and urine. Hepatitis A is an acute Identifies the hepatitis B genotype (A to H) in a patient’s
infection, not a chronic form of the disease. serum/plasma. This is critical for determining treatment
and monitoring response.
HBV Drug Resistance Detection (HBRM)
HBV Assays Detects hepatitis B virus wild-type and drug-induced
Hepatitis B surface antigen (HBsAg) (AUAG) mutations, associated with lamivudine, entecavir
A protein on the surface of HBV; it can be detected and tenofovir.
in high levels in serum during acute or chronic HBV
infection. The presence of HBsAg indicates that the
person is infectious. The body normally produces HCV Assays
antibodies to HBsAg as part of the normal immune HCV Antibody (HEPC)
response to infection. HBsAg is the antigen used to The test indicates exposure to virus but does not
make Hepatitis B vaccine. necessarily signify current infection. The HCV antibody
test may therefore be used to screen patients for
Hepatitis B surface antibody (anti-HBs) (HBIM)
possible HCV infection to detect the presence of
The presence of anti-HBs is generally interpreted as
antibodies to the virus, indicating exposure to HCV.
indicating recovery and immunity from HBV infection.
This test cannot tell if the viral infection is active,
Anti-HBs also develops in a person who has been
only that you were exposed to the virus in the past.
successfully vaccinated against Hepatitis B.
HCV Viral Load (QPCR)
Total Hepatitis B core antibody (anti-HBc) (HBC)
Measures the concentration of hepatitis C viral RNA in
Appears at the onset of symptoms in acute Hepatitis B
patient serum. This state-of-the-art assay enables the
and persists for life. The presence of anti-HBc indicates
viral load at the beginning of treatment to be established
previous or ongoing infection with HBV in an undefined
and, thereafter, monitored to indicate treatment success.
time frame.
HCV Genotype for Treatment (CGEN)
IgM antibody to Hepatitis B core antigen
Determines the HCV genotype in a patient’s serum.
(IgM anti-HBc) (HBCM)
The result is presented as being of either Genotype
Positivity indicates recent infection with HBV
[1, 5, 6], [4] or [2, 3]. This grouping reflects required
(≤6 months). Its presence indicates acute infection.
treatment duration of the different genotypes.
Hepatitis B e antigen and antibody (HEPE)
HCV Drug Resistance
Hepatitis B e antigen (HbeAg): A secreted product of
Detects hepatitis C wild-type or drug-induced mutations
the nucleocapsid gene of HBV that is found in serum
associated with resistance to HCV drugs including
during acute and chronic Hepatitis B. Its presence
NS5A inhibitors, NS5B inhibitors or NS3 inhibitors.
indicates that the virus is replicating and the infected
person has high levels of HBV.
Hepatitis B e antibody (HBeAb or anti-HBe): Produced
by the immune system temporarily during acute HBV
infection or consistently during or after a burst in viral
replication. Spontaneous conversion from e antigen
to e antibody (a change known as seroconversion) is
a predictor of long-term clearance of HBV in patients
undergoing antiviral therapy and indicates lower
levels of HBV.
HEPATITIS B
• Transmission: • Development of chronic form:
Sexual, parenteral, perinatal, direct contact Yes (5% of adult cases).
between individuals. • Prevention:
• Clinical Signs: Vaccination ++++; specific IgG.
Asymptomatic in 90% of cases.
• Main Marker:
• Cure: 95% of cases (adults). HBS Ag, anti HBc IgM, total anti HBc Ab,
• Complications: How to request for Hepatitis B Surface Antigen / A
Cirrhosis and hepatocellular carcinoma.
Anti-HBs Ab, HBe Ag, Anti-HBe Ab, HBV DNA.
Anti-HCV Ab
HBe Ag
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
94 of collection. Turnaround times are quoted as working days.
Virology
Hepatitis C Antibodies
HEPATITIS C
• Transmission: • Complications: • Prevention:
Parenteral, nosocomial, sexual. Cirrhosis and hepatocellular Hygiene, no vaccination.
• Clinical Signs: carcinoma. • Main Marker:
Asymptomatic in 90% of cases. • Development of chronic form: Anti HCV Ab, HCV RNA.
• Cure: Yes (80% of adult cases).
Confirmation by HCV
Viral Load (Quantitative)
Anti-HCV Ab
HCV Ag
HCV RNA
*Reactive 4th Gen HIV Results require confirmation with a follow up venous blood sample.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
96 of collection. Turnaround times are quoted as working days.
Virology
RAPID XPERT HIV-1 RNA VIRAL LOAD
RAPID XPERT HIV-1 RNA QUALITATIVE RAPID TESTING FOR HIV-POSITIVE
EARLY DETECTION FROM 10 DAYS PATIENT PROGNOSIS AND RESPONSE TO
ANTIRETROVIRAL THERAPY
HIV-1 RNA HIV-1 RNA VIRAL LOAD (40 copies/ml)
Sample must be received in the laboratory Sample must be received in the laboratory
within 24 hours of sample taking TAT within 24 hours of sample taking TAT
4 4
HOURS HOURS
LHIV RHIV
STDX
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
98 of collection. Turnaround times are quoted as working days.
Virology
TEST CODE SAMPLE REQS TAT
BB BB B
VIROLOGY BY PCR
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
100 of collection. Turnaround times are quoted as working days.
Tumour markers/sites
TEST CODE SAMPLE REQS TAT
* Results that fall between 4.00 ug/L and 10.00 ug/L will
automatically reflex to a Free PSA with a calculated ratio. HE4
Earlier Detection of Ovarian Tumour
The ratio of Free to Total PSA may help discriminate between
prostate cancer and benign prostatic hyperplasia. HE4 / CA 125 / ROMA
Calculated Algorithm for pre
TAT
TUMOUR MARKERS/SITES and post menopausal risk
of malignant disease 1
DAY
AFP: Liver, Testes Cyfra 21-1: Oesophagus,
BHCG: Testes Lung, Bladder HE4
BRCA1/2: Breast HE4: Ovary
Key: See page 23 for sample-taking and special handling instructions. 101
Tumour markers/sites
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
102 of collection. Turnaround times are quoted as working days.
TDL Genetics
TDL Genetics is a consultant-led service which is
able to provide extensive expertise in the testing,
diagnosis and genetic counselling of inherited
disorders. Genetic tests are performed on DNA
for molecular genetic analysis and on whole chromosomes for cytogenetic analysis. Some tests are part of profiles
that can be linked with assays from other TDL disciplines, such as biochemistry and haematology, to give more
comprehensive results for the patient.
Genetic tests are available for:
• Prenatal diagnosis and rapid trisomy • Genetic variation that influences risk of disease
screening by Amnio-PCR • Identity studies (paternity, zygosity, tissue typing)
• Carrier screening • Fertility studies
• Newborn chromosome analysis • Products of conception
• Confirmation of symptomatic individuals • Cancer
and pre-symptomatic testing
Genetic testing is sometimes complex and tests will vary in their ability
to detect mutations or to detect all patients who have, or will develop, the
disease. Some tests are diagnostic for a condition, others are indicative
or are associated with an altered risk for a condition. Results can affect DNA peaks from
the lives of individuals and have implications for their family, for insurance normal fetus
and employment. Where testing will predict the inheritance of a disease in
a healthy person, counselling and consent are mandatory. For these tests,
please complete the Genetic Request form at the back of the guide (including
informed consent). Our service provides result interpretation and risk
assessment to patients and their family members. Genetic counselling
can be arranged by TDL’s Consultant Clinical Geneticist.
DNA peaks from
To meet the increasing range and complexity of genetic testing we have Down Syndrome fetus
developed an excellent collaboration with other specialist laboratories.
Tests marked GENE are sent to these laboratories within our network and have a fixed price.
GENE panel composition may change throughout the year to reflect new and improved developments.
Turnaround times may be longer if follow-up studies are required.
Specimen Receipt at The Doctors Laboratory is 24 hours a day. Specifically, TDL Genetics results service is
available Monday to Friday 8.30am – 5.30pm with the laboratory also open for processing of samples on
Saturdays from 9.00am – 1.00pm.
Test codes, sample requirement codes, turnaround times, and prices may be found on the following pages.
All samples must be collected in the specified containers, as shown in the key at the back of this guide.
Samples should be fresh and in good condition (e.g. not clotted if EDTA or heparinised whole blood is required)
otherwise testing may be adversely affected and another sample may be required. Small DNA samples are
stored routinely for one year, larger DNA samples can be stored by special arrangement.
Instructions for transportation, sample labelling, and the completion of request forms can be found on the
reverse of the TDL Genetics Request Form.
The locations of the Laboratory and Patient Reception are indicated on the map on the reverse of each request
form. If you do not find the test you require in this directory or need more information and advice please
telephone the laboratory on 020 7307 7409.
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Sending samples to the laboratory
Essential information on sample container label:
Transport arrangements
• Patients surname and forename (not initials)
All specimens should be kept at room temperature
and despatched to the laboratory as soon as possible, • Date of birth
by TDL/international courier, first class post, guaranteed • Hospital number or reference number
next day delivery or a reliable alternative.
If a delay in sending the sample is unavoidable, please Consent forms
refrigerate overnight – DO NOT FREEZE. Specimens must Consent forms (at the back of this guide) are available
not be allowed to come in contact with request forms, for genetic testing. As genetic testing may have
but should be kept separate by using dual – pocketed implications for other family members and is regarded
plastic bags. Specimens for inland postage must be as personal data, it is recommended that written
packed in a rigid crush-proof container according to consent is obtained wherever possible. In cases with
current Post Office guidelines. IATA guidelines should predictive testing for severe disorders, as indicated
be followed for international transport (Advice is available in the laboratory guide, it is essential that patients
from the laboratory). should also be offered formal genetic counselling.
It is the responsibility of the referring clinician to
Labelling of high risk samples obtain appropriate consent from the patient.
Please note that it is the responsibility of the referring
clinician to ensure that high-risk samples are clearly Unlabelled samples
identified to reduce the risk of infection to staff Unlabelled samples will ONLY be processed if the
and others. individual who took the sample can confirm the sample
is from the patient in question. In the absence of
Patient details on request forms this assurance, the sample will be discarded and
and samples a repeat required.
Request and consent forms are available directly
from TDL Genetics.
In order to avoid unnecessary time spent in obtaining
details please provide the following information:
Information for request forms:
• Surname, forename (not initials), date of birth
and biological sex of patient for postnatal referrals
• Full name (not initials) and location of
referring clinician
• Full address of clinician to whom the result
should be sent
• Legible clinical summary, including details
of any relevant family history
• Address for billing – Doctor, patient or other
• Gestation on prenatal samples
• Hospital or reference number
• Test required
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Genetic Testing
THE IMPORTANCE OF CLINICAL DETAILS
Clinical details are very important when providing genetic analysis. The more clinical information that is available
(e.g. details of ultrasound information, phenotypic features or family history) the better the service we can provide.
Failure to provide this information for cytogenetic studies may result in an inaccurate analysis.
MOLECULAR GENETICS
Clinical details can be extremely important for clinical interpretation of a molecular genetic test.
For example, the clinical comments accompanying a cystic fibrosis screening report will vary depending
on whether the patient is a potential gamete donor or a person exhibiting a cystic fibrosis phenotype.
It may also be crucial, where a mutation has already been shown to be segregating in a family, to be provided
with information concerning the mutation and a family pedigree to ensure the correct analysis is performed
and reliable risk figures calculated.
CYTOGENETICS
Cytogenetic analysis is performed according to the Professional Guidelines for the Association of Clinical Genetic
Science and the recommendations provided are dependent on the clinical indications given for each case.
Clinical details inform the investigation at all stages:
• Prior to analysis, clinical details may indicate, for example, that procedures such as chromosome
breakage or leukaemic studies are required, which must be referred to the oncogenomic department
or specialist centre.
• During analysis they may indicate that extra cells should be screened to investigate the possibility of
mosaicism, for example in a diagnosis of suspected Turner syndrome, or that particular chromosomes must
be targeted for high-resolution study, for example chromosome 4 in suspected Wolf-Hirschhorn syndrome.
• When the analysis has been completed they may help to provide an accurate interpretation of the findings
and in some instances prompt further investigations, for example FISH or molecular genetic studies.
When clinical details are not available a routine analysis will be performed and a conditional report issued.
SAMPLE STABILITY
Molecular Genetic Samples
Whole blood collected in EDTA should be sent to the laboratory between 4˚C-28˚C within 48 hours.
Long term storage should be at 2-8°C.
Extracted DNA samples should be sent to the laboratory between 4˚C-28˚C.
Cytogenetic Samples
Cytogenetic studies require living cells, please ensure that samples reach the laboratory as soon
as possible. If a delay before dispatch is unavoidable, samples may be stored in a refrigerator (4°C)
but they must not be frozen.
Samples sent more than 48 hours after sampling, or kept at temperatures below 4˚C
and greater than 38˚C may have inhibited growth.
Information concerning packaging, transportation, and labelling of samples is provided
on the reverse of our TDL Genetics Request Form.
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Requesting additional tests
Any further tests not requested at the time of sample receipt must be requested within:
• 1 week for tests requiring prenatal culture or cultured cells
• 2 weeks for DNA testing
• 2 weeks for cell culture testing
• 3 months for FISH testing
Samples can be stored for longer periods if specifically requested at the time of sample receipt.
PRENATAL DIAGNOSIS
Reasons for analysis: Chromosome studies are requested where pregnancies are identified as being at risk of
a cytogenetic abnormality e.g. positive maternal serum screening combined NT test; fetal abnormalities found
on ultrasound; or where a parent is a known carrier of a chromosome anomaly, or where a high risk trisomy
has been found by NIPT.
Sample requirements:
a) amniotic fluid – 10ml+ in a plain sterile, leak-proof container. Suitable containers can be provided
by the laboratory. The specimen must not be frozen. See sample stability section for cytogenetic samples.
b) chorionic villus – 5mg+ in sterile transport medium. Suitable containers containing medium can be provided
by the laboratory. The specimen must not be frozen. See sample stability section for cytogenetic samples.
c) fetal blood – 1-2ml LITHIUM HEPARIN whole blood, gently mixed to prevent clotting.
The specimen must not be frozen. See sample stability section for cytogenetic samples.
Turnaround time: This is dependent on the rate of cell growth, however, the usual turnaround time
is approximately 2 weeks. A number of circumstances now occur more frequently, as invasive prenatal
diagnosis becomes less common, that may result in delayed reporting time. These include:
a) A delay in transportation in order to collect a batch of samples to reduce courier costs.
Even when couriered promptly, sample growth may be slower than that seen in samples sent immediately.
b) Sampling at early or late gestations, for example to confirm non-invasive tests or follow up anomaly scans.
c) A tendency to take smaller quantities of sample or to take insufficient sample for multiple techniques.
d) The request for karyotyping as an add-on after an initial PCR test.
Fetal blood results will usually be reported by 10 calendar days. For all other prenatal tests,
please contact the laboratory prior to taking samples.
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Notes
a) Maternal contamination, and mosaicism may complicate the analysis and may lead
to the suggestion that a second invasive test is performed.
b) Rarely, cultures fail to grow (overall <1%)
c) Very small chromosome abnormalities may not be detected (this is why the phrase
‘No trisomies or major chromosome abnormalities detected…’ is used in our reports).
d) for TTTs or heavily blood stained amniocentesis samples, please provide a maternal
EDTA blood sample for comparison studies.
SOLID TISSUE
Reasons for analysis: Fibroblast cultures may be used in addition to blood cultures, for example where tissue
specific mosaicism is suspected, or where blood samples cannot be obtained. POC samples may be requested
for early spontaneous miscarriages, stillbirths, or to confirm a prenatal diagnosis.
Sample requirements: All specimens should be placed in a sterile container, preferably containing transport medium.
This can be supplied by the laboratory. Sterile normal saline can be used if transport medium is not available.
Samples must not be placed in formaldehyde or other preservative and must not be frozen. See sample stability
section for cytogenetic samples.
Turnaround time: This is dependent on the rate of cell growth, however, the usual turnaround time
is approximately 4 weeks.
Notes
a) Material from miscarriages has a relatively high culture failure rate (around 20%). Where failure occurs,
alternative molecular methods may be attempted, usually a KaryoLite Bacs-on-Beads assay that can detect
whole monosomy or trisomy of any chromosome, if possible.
b) If no villus or fetal parts are identified in supposedly POC material and a normal female chromosome result
is found, this may indicate that maternal tissue has been cultured (this will be noted on our report).
c) Material from miscarriages can be returned for sensitive disposal if requested at the time of receipt.
If no special request is made, fetal material will be sent for incineration separate from general clinical waste.
Placental and other POC material will be disposed of in general clinical waste for incineration.
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KEY PERSONNEL
Consultant Clinical Geneticist Prof. Michael Patton 020 7307 7409 [email protected]
Consultant Clinical Scientist Elaine Holgado 020 7307 7409 [email protected]
Head of Cytogenetics Rebecca Watts 020 7460 4787 [email protected]
Senior Cytogeneticist Kath Masters 020 7307 7409 [email protected]
Cytogenetics Operations Manager Emma Wilcock 020 7307 7409 [email protected]
Postnatal Lab Manager Allison Daffern 020 7307 7409 [email protected]
Director of Genetics & Molecular Pathology Dr Lisa Levett 020 7307 7409 [email protected]
Head of Genetics & Molecular Pathology Dr Stuart Liddle 020 7307 7409 [email protected]
Operations Manager Andrew Levett 020 3908 1282 [email protected]
Molecular Cytogenetics Manager Alessandra Callegari 020 7307 7409 [email protected]
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TEST CODE SAMPLE REQS TAT
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TEST CODE SAMPLE REQS TAT
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TEST CODE SAMPLE REQS TAT
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TEST CODE SAMPLE REQS TAT
LEOPARD/Noonan/Cardio-Facio-
Requires patient informed consent
Cutaneous/Costello Syndromes
GENE AA 9 6 weeks
NGS Panel – full gene sequencing
Leukaemia Fusion Gene
LMPX A 24 hours
Screening Assay (Q30)
Li-Fraumeni Syndrome (p53-
Requires patient informed consent
related cancer predisposition)
GENE A 9,11 6 weeks
– TP53 sequencing + MLPA
Limb-Girdle Muscular Dystrophy (LGMD) Requires patient informed consent
NGS Panel – full gene sequencing GENE AA 9 6 weeks
Lissencephaly NGS Panel – Requires patient informed consent
full gene sequencing GENE AA 9 8 weeks
Loeys-Dietz Syndrome/Marfan
Requires patient informed consent
Syndrome/Aortopathy NGS
GENE AA 9 9 weeks
Panel – full gene sequencing
Long-QT Syndrome/Brugada Requires patient informed consent
Syndrome – full gene sequencing GENE AA 9 4 weeks
Lowe (Oculocerebrorenal) Requires patient informed consent
Syndrome – OCRL sequencing GENE A9 6 weeks
Lung Disorders NGS Panel Requires patient informed consent
– full gene sequencing GENE AA 9 6 weeks
Lynch Syndrome (HNPCC) NGS
Requires patient informed consent
Panel – full gene sequencing
GENE A A 9,11 4 weeks
+ deletions/duplications
Lysosomal Disorders NGS Panel Requires patient informed consent
– full gene sequencing GENE AA 9 6 weeks
Male Genetic Reproductive Profile GRP AH 9 10-15 days
Marfan Syndrome – FBN1 sequencing Requires patient informed consent
+ deletions/duplications GENE A9 5 weeks
Marfan Syndrome/Loeys-Dietz
Requires patient informed consent
Syndrome/Aortopathy NGS
GENE AA 9 9 weeks
Panel – full gene sequencing
Maturity-Onset Diabetes of the Requires patient informed consent
Young (MODY) Diabetes GENE A 7 weeks
Meckel-Gruber/Joubert Syndrome Requires patient informed consent
NGS Panel – full gene sequencing GENE A 6 weeks
Medium-Chain Acyl-CoA Dehydrogenase Requires patient informed consent
Deficiency – ACADM sequencing GENE A9 5 weeks
Melanoma NGS Panel – full gene Requires patient informed consent
sequencing + deletions/duplications GENE A A 9,11 6 weeks
Microdeletion (common)
PBOB CVS / AF / A 9 5 days
Syndromes – BOBs only
Microphthalmia/Anophthalmia/
Requires patient informed consent
Coloboma NGS Panel –
GENE AA 9 9 weeks
full gene sequencing
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TEST CODE SAMPLE REQS TAT
Noonan/LEOPARD/Cardio-Facio-
Requires patient informed consent
Cutaneous/Costello Syndromes
GENE AA 9 6 weeks
NGS Panel – full gene sequencing
NPM1 mutascreen assay NPM1 A 24 hours
Nystagmus, X-linked Infantile Requires patient informed consent
– FRMD7 gene sequencing GENE A9 7 weeks
Oculocutaneous Albinism/Hermansky-
Requires patient informed consent
Pudlak Syndrome/Pigmentation
GENE AA 9 5 weeks
NGS Panel – full gene sequencing
Oculopharyngeal Muscular Dystrophy Requires patient informed consent
– PABPN1 repeat analysis GENE A9 5 weeks
Optic Atrophy NGS Panel – Requires patient informed consent
full sequencing OPA1 + OPA3 genes GENE AA 9 6 weeks
Osteogenesis Imperfecta NGS Requires patient informed consent
Panel – full gene sequencing GENE AA 9 7 weeks
Ovarian Cancer NGS Panel – full gene Requires patient informed consent
sequencing + deletions/duplications GENE A A 9,11 6 weeks
p53-related cancer predisposition
Requires patient informed consent
(Li-Fraumeni Syndrome) –
GENE A 9,11 6 weeks
TP53 sequencing + MLPA
Pancreatic Cancer NGS Panel – full gene Requires patient informed consent
sequencing + deletions/duplications GENE A A 9,11 4 weeks
Paraganglioma/Pheochromocytoma
Requires patient informed consent
NGS Panel – full gene sequencing
GENE A A 9,11 4 weeks
+ deletions/duplications
Paternity Testing (postnatal and
A / AF / CVS 9,11,12
prenatal) – sample required from PATT 5 days
Contact lab
each person being tested (3 people)
Pelizaeus-Merzbacher Disease – Requires patient informed consent
PLP1 sequencing + deletions/duplications GENE A9 8 weeks
Pendred Syndrome – SLC26A4 Requires patient informed consent
gene sequencing GENE A9 6 weeks
Periodic Fever/Autoinflammation Requires patient informed consent
NGS Panel – full gene sequencing GENE AA 9 9 weeks
Peutz-Jegher Syndrome – STK11 Requires patient informed consent
sequencing + deletions/duplications GENE A9 5 weeks
Phelan-McDermid Syndrome KARY,
CVS / AF / H 9 12-17 days
– karyotype + FISH FISH
Pheochromocytoma/Paraganglioma
Requires patient informed consent
NGS Panel – full gene sequencing
GENE A A 9,11 4 weeks
+ deletions/duplications
Pigmentation/Oculocutaneous Albinism/
Requires patient informed consent
Hermansky-Pudlak Syndrome
GENE AA 9 5 weeks
NGS Panel – full gene sequencing
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ARRAY CGH TESTING
Chromosome abnormalities can be associated with developmental delay, autism spectrum disorder,
learning difficulties, dysmorphic features and other congenital abnormalities.
Array CGH can detect smaller genetic changes than is possible by conventional karyotyping, and can
provide accurate information on the size and possible consequences of the gains (duplications) or losses
(deletions) identified. Multiple studies have shown that Array CGH, when applied to appropriate patients,
will detect up to three times more pathogenic chromosome imbalances than karyotyping due to its
greater precision and sensitivity.
Array CGH testing is now considered to be the front line test for patients presenting with developmental delay
(motor or growth), autism spectrum disorder, moderate to severe learning difficulties, dysmorphic features,
with or without congenital abnormalities. Consortiums in the USA and many EU countries have adopted
Array CGH as the front line test in this patient cohort.
Array CGH is now more frequently used for prenatal studies as an adjunct or replacement for conventional
cytogenetic studies, particularly where structural fetal abnormalities are seen at ultrasound scan but also at
a patient’s or doctor’s request. The technique may also be utilised as a follow up test to characterise anomalies
detected by a previous study (e.g. an apparently balanced de novo rearrangement or marker chromosome).
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PAN-ETHNIC CARRIER SCREENING
The Fulgent Beacon carrier panel is a comprehensive genetic screen for people of all ethnic backgrounds.
The panel analyses more than 400 genes, in which mutations may cause over 440 different recessive
disorders. Testing includes Cystic Fibrosis, Sickle Cell Disease, Thalassemia and Spinal Muscular Atrophy.
These conditions vary in morbidity, mortality and treatment.
The Beacon carrier screen can also be filtered to report only on diseases common to the Jewish population –
such as Bloom Syndrome, Canavan Disease, Gaucher Syndrome and Tay-Sachs Disease.
Patient Information Partner Information Physician: Laboratory: Patient Information Partner Information Physician: Laboratory:
Patient Last, Patient First Not Tested Physician Last, Physician First Fulgent Genetics Patient Last, Patient First Not Tested Physician Last, Physician First Fulgent Genetics
DOB: Jan 01, 1900 Portal Example Lab [DO NOT USE] CAP#: 8042697 DOB: Jan 01, 1900 Portal Example Lab [DO NOT USE] CAP#: 8042697
Sex: ? CLIA#: 05D2043189 Sex: ? CLIA#: 05D2043189
MR#: 000-000-000 Phone: Laboratory Director: MR#: 000-000-000 Phone: Laboratory Director:
FD Patient#: FT-PT21496 Fax: Dr. Hanlin (Harry) Gao FD Patient#: FT-PT21496 Fax: Dr. Hanlin (Harry) Gao
Report Date: {{DATESIGNED}} Report Date: {{DATESIGNED}}
Accession: Accession: Accession: Accession:
FT-1612508 N/A FT-1612508 N/A
Test#: FT-TS51816 Test#: FT-TS51816
Specimen Type: TBD Specimen Type: TBD
Collection Date: Collection Date:
INTERPRETATION: INTERPRETATION:
Based on these results, there is increased risk to have a child with an FMR1-related condition. See below for details. A likely pathogenic variant in the CLN3 gene was identified. Based on these results, there is an approximately 1 in 920
chance of having a child affected with Neuronal ceroid lipofuscinosis. Testing for mutations in this gene in the partner is
Testing for copy number changes in the SMN1 gene was performed to screen for your carrier status for Spinal Muscular highly recommended to better understand this risk. Please contact the lab for this service. See page 2 of this report for more
Atrophy. Two copies of the SMN1 gene were detected. These results are within the normal range for non-carriers. See information.
Limitations section for more information.
Testing for a 3 nucleotide (CGG) repeat sequence in the FMR1 gene was performed to screen for your carrier status for
This carrier screening test does not screen for all possible genetics conditions, nor for all possible mutations in every gene Fragile X Syndrome. The repeat sizes detected were: 18 and 22 repeats. These results are within the normal range.
tested. Individuals with negative test results may still have up to a 3-4% risk to have a child with a birth defect due to genetic Therefore, you are not considered a carrier for Fragile X Syndrome.
and/or environmental factors.
Testing for copy number changes in the SMN1 gene was performed to screen for your carrier status for Spinal Muscular
Patients may wish to discuss any carrier results with blood relatives, as there is an increased chance that they are also Atrophy. Two copies of the SMN1 gene were detected. These results are within the normal range for non-carriers. See
carriers. Limitations section for more information.
This carrier screening test does not screen for all possible genetics conditions, nor for all possible mutations in every gene
tested. Individuals with negative test results may still have up to a 3-4% risk to have a child with a birth defect due to genetic
and/or environmental factors.
Patients may wish to discuss any carrier results with blood relatives, as there is an increased chance that they are also
carriers.
Patient: Patient Last, Patient First; Sex: ?; Accession#: FT-1612508; FD Patient#: FT-PT21496; Patient: Patient Last, Patient First; Sex: ?; Accession#: FT-1612508; FD Patient#: FT-PT21496;
DOB: Jan 01, 1900; MR#: 000-000-000 DocID: ; Page 1 of 17 DOB: Jan 01, 1900; MR#: 000-000-000 DocID: ; Page 1 of 17
Male patients will not be screened for X-linked conditions. If an X-linked condition is suspected in a male patient
please contact the laboratory or a genetics specialist about diagnostic testing for that particular condition.
Limitations
A normal result does not rule out the possibility that the patient carries a rare mutation not detectible by
this particular assay. For this reason, this test is also not appropriate to use as a direct prenatal screen
(both parents must be confirmed carriers for a particular disease before we can offer prenatal diagnosis).
Screening is not designed to detect somatic mutations.
TEST CODE SAMPLE REQS TAT
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• Trisomy 18 (Edwards syndrome) and Trisomy 13
(Patau syndrome) are associated with a high rate
of miscarriage. These babies are born with severe
brain abnormalities and often have congenital heart
performed in the UK
NON-INVASIVE PRENATAL TESTING (NIPT) defects as well as other birth defects. Most affected
The Harmony test is a cell-free DNA-based prenatal individuals die before or soon after birth, and very
blood screen. It is being used in more than 100 few survive beyond the first year of life.
countries around the world, and has been used • Sex chromosome conditions occur when there
to guide clinical care in over 1.4 million pregnancies. is a missing, extra, or incomplete copy of the X
The test can be used in singleton, twin, and egg-donor or Y chromosomes. The Harmony test with sex
pregnancies and has been validated for use in pregnant chromosome aneuploidy panel option can assess risk
women aged 16 to 48. It can be administered as for XXX, XYY, XXYY, XXY (Klinefelter syndrome), and
early as 10 weeks gestation. a missing X chromosome in a girl (Turner syndrome).
The test can screen for: An option is also available to look for Turner syndrome
• Trisomies 21, 18, and 13 only (and not the other sex chromosome conditions).
If the mother is interested in having this optional
• Sex chromosome aneuploidy testing, she should talk with her healthcare provider
• Monosomy X to determine if it is right for her. This option is not
• Fetal sex available for twin pregnancies.
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In the same way, if the test results show a ‘low
probability’ of the fetus having trisomy 21, 18, 13 or
a sex chromosome condition, it is unlikely that the fetus
has one of these conditions. However, there is a very
small risk that not all trisomic fetuses will be detected.
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MALE GENETIC CARRIER SCREEN RECURRENT MISCARRIAGE
REPRODUCTIVE PROFILE (PAN-ETHNIC) PROFILE (FEMALE)
Chromosome Analysis Targets 400+ Autosomal FBC
Y-Chromosome Microdeletions Recessive and X-linked Coagulation Profile
Cystic Fibrosis Carrier Screen Inherited Disorders** Antithrombin III
(139 common mutations) Factor V Leiden
PolyT (5T,7T,9T) if clinically ** Male patients will not Common Mutation
indicated be screened for X-linked Factor II Prothrombin
conditions (e.g., FMR1, etc.). Common Mutation
MTHFR Common Variants
TAT TAT
Fibrinogen
10-15 4 Lupus Anticoagulant
DAYS WEEKS
Protein C
GRP GENE Free Protein S Ag
Anticardiolipin Abs
AH9 A9 Chromosome Analysis
Please request Partner’s TAT
THROMBOTIC RISK PROFILE
CARRIER SCREEN
(ASHKENAZI JEWISH)
Chromosome Analysis using
a separate request form. 10-15
DAYS
AABCCC 18
A 9
ABK or CBK
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In-vivo tests
These tests, ideally, must be carried out by appointment. Please telephone 020 7307 7383
for details, information for patient preparation, and appointment times. Sample taking fees
for Extended tests are charged at £98.00 per visit.
EXTENDED TESTING
• 50g liquid glucose is consumed for the glucose challenge test/Mini-GTT.
• 75g liquid glucose is consumed for all other glucose tests.
• Each sample tube must be labelled with time of collection.
EXTENDED TESTS
TEST CODE SAMPLE REQS COLLECTION TIME TAT
(MINUTES POST-GLUCOSE)
Contact 020 7025 7997
Lactose Tolerance Test LTT By appointment only 1 day 129
(Phlebotomy)
Synacthen Contact 020 7025 7997
SYNA By appointment only 1 day 129
Stimulation Test (Phlebotomy)
ANTIBIOTIC ASSAYS
TEST CODE SAMPLE REQS TAT
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Therapeutic drug assays
There are three different collection times for Therapeutic Drug Monitoring:
TROUGH LEVEL Blood should be collected just before the next dose. Trough Levels
check that the appropriate drug concentration is being maintained.
PEAK LEVELS Sample collection time is dependent on specific drug type and method of
administration. Peak levels check that the drug level is not in the toxic range.
SUSPECTED TOXICITY Blood can be collected any time.
All collections should have the following noted on the request form:
• Dosage schedule including the amount and frequency and time of the last dose
• Time of specimen collection
• Clinical status of patient (e.g. routine, suspected toxicity)
• Name(s) of other drugs being taken by the patient
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
134 of collection. Turnaround times are quoted as working days.
Therapeutic drug assays
TEST CODE SAMPLE REQS TAT
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Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
136 of collection. Turnaround times are quoted as working days.
Allergy
Allergy, Asthma and Autoimmune diseases are increasing around the world, especially in industrialised
countries and affect all ages. Since every country has their own dietary habits there are noteworthy
differences in the allergens causing food allergy.
B B B
Key: See page 23 for sample-taking and special handling instructions. 137
Allergy
TEST CODE SAMPLE REQS TAT
Total IgE with Milk Total IgE with Milk Gluten single IgE Allergen
individual IgE Peanut individual IgE Nettle Endomysial Antibodies IgA
allergens for: Soya Bean allergens for: Peanut Deamidated Gliadin IgG
Cat Dander Wheat Birch Timothy Grass Antibodies
Egg White Cat Dander Tissue Transglutaminase IgA
Egg Yolk Dog Dander HLA DQ2/DQ8
Fish Mix Egg White Total IgA
Hazelnut TAT Egg Yolk TAT TAT
House Dust Mite 2 House Dust Mite 2 10
DAYS DAYS DAYS
B B ABB
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
138 of collection. Turnaround times are quoted as working days.
Allergy
IgE ALLERGY PROFILE 1 IgE ALLERGY PROFILE 3
(Food and inhalants) (Food)
Total IgE with individual Tree Mix, inc. Total IgE with individual Egg Yolk
IgE allergens for: Box Elder IgE allergens for: Kiwi
Common Silverbirch Codfish Peanut
Grass Mix, inc.
Hazel Cow’s Milk Sesame TAT
Cocksfoot
Meadow Fescue Oak
London Plane
Egg White Soya
Wheat
2
Meadow DAYS
Rye Maple
Timothy Sycamore 3A
Weed Mix, inc. Single Allergens (19)
Common Ragweed Beef B
Giant Ragweed Bermuda Grass
Western Ragweed Cat Dander IgE ALLERGY PROFILE 4
Clam (Nuts and Seeds)
Dust Mix, inc. Common Silver Birch
Blatella germanica Cow’s Milk Total IgE with individual Pecan
Dermatophagoides Crab IgE allergens for: Pine Nut
pteronyssinus Dog Dander Pistachio
Dermatophagoides Egg White Almond
Brazil Nut Poppy Seed
farinae Egg Yolk Pumpkin Seed
Hollister-Stier Labs Cashew
Fish (Cod) Hazel Nut Sesame Seed
Mould Mix, inc. Sunflower Seed TAT
Hazel Nut Macadamia Nut
A. alternata Horse Dander Peanut Walnut 2
DAYS
Aspergillus fumigatus Latex
Candida albicans Nettle 4A
Cladosporium herbarum Peanut
Helminthosporium Shrimp/Prawn
halodes Soya Bean TAT B
Penicillium notatum Wheat 2
DAYS IgE ALLERGY PROFILE 5
(Children’s Panel)
1A
Total IgE with individual Mite, Pteronyssinus
BB IgE allergens for: Peanut
Cat Dander Soya Bean
Cow’s Milk Timothy Grass
IgE ALLERGY PROFILE 2 Wheat Flour TAT
Egg White
(Inhalants)
Egg Yolk 2
DAYS
Total IgE with individual Common Ragweed
IgE allergens for: Derma farinae 5A
Alternaria Dog Dander
Aspergillus House Dust Mite B
Birch Pollen Horse Dander
Timothy Grass TAT
Cat Dander
Cladosporium 2 IMMUNOCAP ISAC PANEL
DAYS
ISAC
Key: See page 23 for sample-taking and special handling instructions. 139
Allergy
IgE ALLERGY PROFILE 6 IgE ALLERGY PROFILE 10
(Shellfish) (Insects)
Total IgE with individual Lobster Total IgE with individual Paper Wasp
IgE allergens for: Octopus IgE allergens for: Yellow Hornet
Clam Prawns/Shrimp Common Wasp – White Faced
Crab Scallop TAT
Yellow Jacket Hornet TAT
6A 10A
B B
Total IgE with individual Sardine/Pilchard Total IgE with individual Salmon
IgE allergens for: Salmon IgE allergens for: Scallop
Codfish Sole Cod Squid TAT
Mackerel Swordfish TAT Prawn/Shrimp Tuna
2
Plaice Tuna
2 DAYS
DAYS
11A
7A
B
B
IgE ALLERGY PROFILE 12
IgE ALLERGY PROFILE 8 (Milk & Milk Proteins)
(Cereal – singles)
Total IgE with individual Cow’s Milk
Total IgE with individual IgE allergens for: Goat’s Milk
IgE allergens for: Alpha-lactalbumin – Mare’s Milk
Barley milk proteins Sheep’s Milk
Oat Beta-lactoglobulin – Whey
Rye TAT milk proteins (cow and ewe) TAT
8A 12A
B B
9A 13A
B B
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
140 of collection. Turnaround times are quoted as working days.
Allergy
Allergens, when requested individually are priced as single tests, sample 1 x B (up to 5 allergens).
Protein allergens are manufactured by Thermofisher (Phadia) and are IgE specific.
Key: See page 23 for sample-taking and special handling instructions. 141
Allergy
Phoma betae m13 Mouse serum proteins e76 INSECTS
Rhizopus nigricans m11 Mouse urine proteins e72 Berlin beetle i76
Staphylococcal enterotoxin A m80 Parakeet droppings e197 Blood worm i73
Staphylococcal enterotoxin B m81 Parakeet serum e198 Cockroach, American i206
Staphylococcal enterotoxin C Parrot feathers e213 Cockroach, German i6
m223 Pigeon feathers e215 Fire ant i70
Staphylococcal enterotoxin TSST Rabbit epithelium e82 Grain weevil i202
m226 Rabbit, serum proteins e206 Green nimitti i72
Stemphylium herbarum Rabbit, urine proteins e211 Horse fly i204
(S. botryosum) m10 Rat epithelium e73 Mediterranean flour moth i203
Tilletia tritici m201 Rat epithelium, serum proteins Mosquito i71
Trichoderma viride m15 and urine proteins e87 Moth i8
Trichophyton mentagrophytes var. Rat serum proteins e75
goetzii m210 Rat urine proteins e74 VENOMS
Trichophyton mentagrophytes var. Reindeer epithelium e202 Bumblebee i205
interdigitale m211 Sheep epithelium e81 Common wasp (Yellow jacket i3
Trichophyton rubrum m205 Swine epithelium e83 European Paper Wasp i77
Ulocladium chartarum m204 Turkey feathers e89 European hornet i75
Honey bee i1
EPIDERMALS AND MITES Paper wasp i4
ANIMAL PROTEINS Acarus siro (Storage mite) d70 White-faced hornet i2
Budgerigar droppings e77 Blomia tropicalis Yellow hornet i5
Budgerigar feathers e78 (House dust mite) d201
Camel dander u328 Dermatophagoides farinae DRUGS
Canary bird droppings e200 (House dust mite) d2 Amoxicilloyl c6
Canary bird feathers e201 Dermatophagoides microceras Ampicilloyl c5
Cat dander e1 (House dust mite) d3 Cefaclor c7
Chicken droppings e218 Dermatophagoides pteronyssinus Chlorhexidine c8
Chicken feathers e85 (House dust mite) d1 Gelatin bovine c74
Chicken, serum proteins e219 Euroglyphus maynei Insulin human c73
Chinchilla epithelium e208 (House dust mite) d74 Penicilloyl G c1
Cow dander e4 Glycyphagus domesticus Penicilloyl V c2
Deer epithelium e216 (Storage mite) d73 Pholcodine c261
Dog dander e5 Lepidoglyphus destructor Morphine c260
Duck feathers e86 (Storage mite) d71 Suxamethonium
Ferret epithelium e217 Tyrophagus putrescentiae (succinylcholine) c202
Finch feathers e214 (Storage mite) d72
Fox epithelium e210 OCCUPATIONAL
Gerbil epithelium e209 ALLERGEN COMPONENTS Bougainvillea k214
Goat epithelium e80 See page 145 for Component Cotton seed k83
Goose feathers e70 Testing and Component Ethylene oxide k78
Guinea pig epithelium e6 Allergen Profiles Ficus k81
Hamster epithelium e84 Formaldehyde/Formalin k80
Horse dander e3 HOUSE DUST Green coffee bean k70
Mink epithelium e203 Greer Labs., Inc. h1 Hexahydrophtalic anhydrid k209
Mouse epithelium e71 Hollister-Stier Labs. h2 Isocyanate HDI (Hexamethylene
Mouse epithelium, diisocyanate) k77
serum proteins and urine Isocyanate MDI (Diphenylmethane
proteins e88 diisocyanate) k76
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
142 of collection. Turnaround times are quoted as working days.
Allergy
Isocyanate TDI (Toluene Jujube f336 Maize, Corn f8
diisocyanate) k75 Kiwi f84 Oat f7
Ispaghula k72 Lemon f208 Pea f12
Latex k82 Lettuce f215 Peanut f13
Methyltetrahydrophtalic Lime f306 Pecan nut f201
anhydrid k211 Mandarin (tangerine, clementine, Pine nut, pignoles f253
Phthalic anhydride k79 satsumas) f302 Pistachio f203
Silk k74 Mango f91 Poppy seed f224
Silk waste k73 Melon f87 Pumpkin seed f226
Sunflower seed k84 Olive (black, fresh) f342 Quinoa f347
Trimellitic anhydride, TMA k86 Onion f48 Rape seed f316
Orange f33 Red kidney bean f287
PARASITES Papaya f293 Rice f9
Anisakis p4 Passion fruit f294 Rye f5
Ascaris p1 Peach f95 Sesame seed f10
Echinococcus p2 Pear f94 Soybean f14
Persimon (kaki fruit, sharon) f301 Spelt wheat f124
MISCELLANEOUS Pineapple f210 Sugar-beet seed f227
Cotton, crude fibers o1 Plum f255 Sweet chestnut f299
Mealworm o211 Potato f35 Walnut f256
MUXF3 CCD, Bromelain o214 Pumpkin f225 Wheat f4
Seminal fluid o70 Raspberry f343 White bean f15
Streptavidin o212 Red currant f322
Spinach f214 FOODS – SPICES
FOODS – FRUITS & VEGETABLES Strawberry f44 Allspice f339
Apple f49 Sweet potato f54 Anise f271
Apricot f237 Tomato f25 Basil f269
Asparagus f261 Watermelon f329 Bay leaf f278
Aubergine, eggplant f262 Black pepper f280
Avocado f96 FOODS – SEED, Caraway f265
Bamboo shoot f51 LEGUMES & NUTS Cardamon f267
Banana f92 Almond f20 Chilipepper f279
Beetroot f319 Barley f6 Clove f268
Blackberry f211 Blue vetch f310 Coriander f317
Blueberry f288 Brazil nut f18 Curry (Santa Maria) f281
Broccoli f260 Buckwheat f11 Dill f277
Brussel sprouts f217 Cashew nut f202 Ginger f270
Cabbage f216 Chick pea f309 Green pepper (unripe seed) f263
Carrot f31 Coconut f36 Lovage f275
Cauliflower f291 Common millet f55 Mace f266
Celery f85 Fenugreek f305 Marjoram f274
Cherry f242 Foxtail millet f56 Mint f332
Cucumber f244 Gluten f79 Mustard f89
Date f289 Green bean f315 Oregano f283
Fennel, fresh f276 Hazel nut f17 Paprika, Sweet pepper f218
Fig f328 Lentil f235 Parsley f86
Garlic f47 Lima bean f182 Tarragon f272
Grape f259 Linseed f333 Thyme f273
Grapefruit f209 Lupin seed f335 Vanilla f234
Guava f292 Macadamia nut f345
Key: See page 23 for sample-taking and special handling instructions. 143
Allergy
FOODS – FISH, SHELLFISH Egg f245
& MOLLUSCS Egg white f1
Abalone f346 Egg yolk f75
Anchovy f313 Turkey meat f284
Blue mussel f37
Cat fish f369 FOODS – MEAT
Chub mackerel f50 Beef f27
Clam f207 Elk/moose meat f285
Crab f23 Mutton f88
Crayfish f320 Pork f26
Fish (cod) f3 Rabbit f213
Gulf flounder f147
Haddock f42 FOODS – MILK
Hake f307 Cheese, cheddar type f81
Halibut f303 Cheese, mold type f82
Herring f205 Cow’s whey f236
Jack mackerel, Scad f60 Goat milk f300
Langust (spiny lobster) f304 Mare’s milk f286
Lobster f80 Milk f2
Mackerel f206 Milk, boiled f231
Megrim f311 Sheep milk f325
Octopus f59 Sheep whey f326
Orange roughy f412
Oyster f290 FOODS – ADDITIVES
Pacific squid f58 Carob (E410) f296
Plaice f254 Guar, guar gum (E412) f246
Pollock f413 Gum arabic (E414) f297
Red snapper f381 Tragacanth (E413) f298
Salmon f41 Cochineal extract
Sardine (Pilchard) f308 (Carmine red) (E120) f340
Sardine, Japanese Pilchard f61
Scallop f338 FOODS – MISCELLANEOUS
Shrimp f24 Cacao f93
Snail f314 Coffee f221
Sole f337 Honey f247
Squid f258 Hop (fruit cone) f324
Swordfish f312 Malt f90
Tilapia f414 Mushroom (champignon) f212
Trout f204 Tea f222
Tuna f40 Yeast f45
Walleye pike f415
Whitefish (Inconnu) f384
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
144 of collection. Turnaround times are quoted as working days.
Allergy
COMPONENT TESTING
Using ImmunoCAP Allergen Components can help refine the understanding of sensitisation, by assessing
a person’s sensitisation pattern at the molecular level. When used in conjunction with traditional extract-
based IgE testing, these provide information at the individual component level.
For more information, please contact the Immunology Department on 020 7025 7917.
TEST CODE SAMPLE REQS TAT
Key: See page 23 for sample-taking and special handling instructions. 145
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
146 of collection. Turnaround times are quoted as working days.
Vitamins, Nutrition and Lifestyle
VITAMIN B PROFILE VITAMIN PROFILE 1 MINERAL SCREEN
AAB ABB7 BK
MINERAL SCREEN
SPORTS/PERFORMANCE PROFILE VITAMIN PROFILE 2
– WHOLE BLOOD
FBC/ESR Vitamin A Whole Blood Potassium
Biochemistry Profile Beta Carotene Whole Blood Magnesium
HDL/LDL Vitamin B1 Whole Blood Calcium
Ferritin Vitamin B2 Whole Blood Manganese
C-Reactive Protein Vitamin B3 Whole Blood Zinc
Omega 3/Omega 6 Vitamin B6 Whole Blood Copper
Mineral Screen Vitamin B9 (Red Cell Folate) Whole Blood Selenium
Vitamin B9 (Red Cell Folate) Vitamin B12 (Active) Whole Blood Chromium
Vitamin B12 (Active) Vitamin C (Frozen)
Vitamin D (25-OH)
TAT Vitamin E TAT TAT
5 5 5
DAYS DAYS DAYS
AAABBBB A A A B B 7,13 HH
GK4
Key: See page 23 for sample-taking and special handling instructions. 147
Vitamins, Nutrition and Lifestyle
TEST CODE SAMPLE REQS TAT
This provides valuable diagnostic information, which can be assimilated with other diagnostic markers
in the assessment of nutritional status, and compares favourably to semi-quantitative functional assays.
For fertility and lifestyle refer to page 60.
TEST CODE SAMPLE REQS TAT
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
148 of collection. Turnaround times are quoted as working days.
Vitamins, Nutrition and Lifestyle
TEST CODE SAMPLE REQS TAT
Omega3/6
Essential Red Cell Fatty Acids Omega-3/Omega-6
Omega-3 is the name given to a family of polyunsaturated fatty acids, which the body needs but cannot
manufacture itself. Omega-3 fats are used as the building blocks for fat derived hormones such as
prostaglandins and leukotrienes. The hormones with an Omega-3 base tend to reduce inflammation,
while those that have an Omega-6 base increase inflammation. In the cell membrane the competition
between these two essential fats has a direct bearing on the type of local hormone produced and the
level of inflammation in the cell.
The Omega-6 to Omega-3 ratio in the cell membranes is key to the development of inflammatory
disorders such as rheumatoid arthritis and heart disease. Diets low in oily fish and high in grains will
promote inflammation and affect good health. The ratio of Omega-6 to Omega-3 in the West is around
15 to 1, fifteen times more Omega-6 on the cell membrane promoting inflammation. Having twice as
much Omega-6 is considered by most experts to be the optimal amount but a ratio of 2:1 is not easy to
produce by diet alone. Many people are aware of the health benefits of Omega-3 but the supplementation
to achieve optimal health is erratic. Being able to test for Essential Red Cell Fatty Acids (Omega-6/
Omega-3 ratio) identifies a person’s current status and is sufficiently specific to allow an accurate
supplementation recommendation to be made.
Results show the Omega Ratio with a clear recommendation for the required level of Omega
Supplementation (if any) to achieve optimal levels.
Results show the ratio of Omega 3 to Omega 6, against an optimal ratio and provide a supplementation recommendation
to achieve this optimal ratio.
TEST CODE SAMPLE REQS TAT
Key: See page 23 for sample-taking and special handling instructions. 149
TDL Tinies™ and Self-collection samples
TDL TINIES™ ([email protected])
This list of tests covers some of the range that can be offered to patients for self-collection,
using TDL TINIES™ and Royal Mail postal packs. Orders for TDL TINIES™ (packs with instructions)
can be made up by TDL, by arrangement, and sent individually to patients, or supplied directly to doctors
or healthcare companies. This is not a patient self-referral service and it is not point of care testing.
All testing is undertaken in the laboratory and results are always returned directly to the healthcare
company or doctor, not to the patient.
TDL TINY™ samples can be combined with other self-collected samples types (e.g. urine, stool,
swabs, HPV).
In the case of positive Sexual Health, results will be reported with the recommendation
for a venous sample to undertake confirmatory sample.
The sample volume from one TINY sample, when filled to the upper fill line, is 600 microlitres. These, on
receipt in the laboratory, are centrifuged and provide a volume of approximately 300 microlitres of serum/
plasma (depending on the tube type used). Different tests require varying amounts of sample, and this,
together with analyser dead volumes, means that although certain tests can be carried out from TINY
tubes, many tests simply cannot be successfully processed achieved from these smaller sample volumes.
TDL TINY™ microtainers are manufactured by BD Diagnostics. They are designed for samples
collection from skin puncture. BD Microtainers come with a variety of additives for various tests,
have visible fill lines, and are colour coded as for standard BD Vacutainer tubes. Tubes and Lancets
are CE marked. TDL TINY™ packs are made up by TDL and contain everything needed for a patient
to self-collect their blood sample.
Recommendation: most people are not experienced at self-collection of their own blood. Whilst it
is certainly possible to process a number of tests from one TINY and it is possible to collect blood drops
for two or three microtainers – the most successful outcomes are collected by patients who read the
instructions given in each pack, and who collect enough sample for one microtainer. Instructions for
sample collection are enclosed in each pack. A completed request form must be enclosed with the
returned sample. Results will always be sent to the requesting doctor/healthcare organisation.
Visit http://www.tdlpathology.com/test-information/test-service-updates/tdl-tinies
For information and packs, please contact Annette Wilkinson 020 7307 7343
or email [email protected].
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
150 of collection. Turnaround times are quoted as working days.
TDL Tinies™ and Self-collection samples
BIOCHEMISTRY
TEST CODE SAMPLE REQS
Amylase AMY B
Calcium CA B
Calcium + Vitamin D CALD B
Carbohydrate Deficient Transferrin CDT B
C Reactive Protein CRP B
C Reactive Protein (High Sensitivity) HCRP B
Ferritin FERR B
HbA1c GHB A
Iron Status Profile (FE/TIBC/FERR) ISP B
Liver Function Tests LFT B
Lipid Profile LIPP B
Lp-PLA2 (PLAC) Test PLA2 B
Uric Acid UA B
Vitamin B12 (Active) B12 B
Vitamin D (25-OH) VITD B
ENDOCRINOLOGY
TEST CODE SAMPLE REQS
AFP AFP B
Antimullerian Hormone AMH B
Beta HCG (Quantitative) QHCG B
Cortisol CORT B
DHEA Sulphate DHEA B
Female Hormone (LH/FSH/PROL/OEST) FIP B
FSH FSH B
HRT Profile 1 (FSH/OEST/PROG) HRT B
Oestradiol OEST B
Progesterone PROG B
Prolactin PROL B
SHBG SHBG B
Testosterone TEST B
Thyroid Profile 1 (Free T4/TSH) TF B
Thyroid Profile 3 (Free T3/Free T4/TSH) TF3 B
IMMUNOLOGY
TEST CODE SAMPLE REQS
Borrelia Antibodies (IgG/IgM) BORR B
Borrelia Antibodies (IgM) BORM B
Endomysial Antibodies IgA AEAB B
Gliadin Antibodies (IgG) AGAB B
H. pylori Antibodies (IgG) HBPA B
Tissue Transglutaminase IgA TAA B
Key: See page 23 for sample-taking and special handling instructions. 151
TDL Tinies™ and Self-collection samples
VIROLOGY / SEXUAL HEALTH
TEST CODE SAMPLE REQS
COVID-19 Roche Total Antibody IgG/IgM (SARS-CoV-2) TCOV CE marked self-collection kit*
Hepatitis B Surface Antigen THBA B
Hepatitis B Immunity (IgG) THBI B
Hepatitis C Antibodies THCV B
HIV1&2 Abs/p24 Ag THIV B
HPV mRNA (All High Risk Subtypes) HPVY Self-collection kit
HPV Individually Typed High Risk DNA Subtypes HPVZ Self-collection kit
Syphilis IgG/IgM TSYP B
*See details below – CE marked self-collection kits for COVID must be used.
TUMOUR MARKERS
TEST CODE SAMPLE REQS
AFP AFP B
Beta HCG(Oncology) HCGQ B
CA 15-3 C153 B
CA 19-9 C199 B
CA 125 C125 B
CEA CEA B
HE4 + ROMA HE4 B
Prostate Specific Antigen PSPA B
LIFESTYLE
TEST CODE SAMPLE REQS
Omega 3/Omega 6 OMG3 A
Vitamin B9 (Folic Acid) Red Cell RBCF A
Vitamin B9 (Folic Acid) Serum FOLA B
Vitamin B12 (Active) B12 B
Vitamin D (25-OH) VITD B
Self-collection capillary samples must be taken using CE marked IVD for COVID Postal kits
The kits include a Royal Mail Tracked 24 return label. Contact [email protected] for details.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
152 of collection. Turnaround times are quoted as working days.
TDL Tinies™ and Self-collection samples
Key: See page 23 for sample-taking and special handling instructions. 153
TDL Tinies™ and Self-collection samples
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
154 of collection. Turnaround times are quoted as working days.
TDL Tinies™ and Self-collection samples
Key: See page 23 for sample-taking and special handling instructions. 155
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
156 of collection. Turnaround times are quoted as working days.
Screening for Drugs of Abuse /Alcohol
TEST CODE SAMPLE REQS TAT
Chain of custody refers to the system of controls governing the entire urine collection, processing and
storage of sample to ensure that a particular urine specimen originated from a particular individual and that
the reported results relate, beyond doubt, to that specimen. Chain of custody requires attention to detail so
that it is possible to prove that there has been no opportunity for the sample to be accidentally or maliciously
adulterated. Sample collection should be undertaken by collectors who are well versed in the protocols of
chain of custody.
Samples submitted for analysis will undergo initial screening. Urinary creatinine is routinely measured during
testing to verify the validity of the sample submitted. Creatinine levels below normal occur when the urine
has been diluted, either directly or by drinking large amounts of water before providing the urine sample.
Chain of custody containers, forms, seals and barcodes are provided by TDL on request. All Chain
of Custody, and non-chain, samples with positive findings will proceed to identification/confirmation
by Gas Chromotography/Mass Spectrometry.
Key: See page 23 for sample-taking and special handling instructions. 157
Screening for Drugs of Abuse /Alcohol
DRUGS OF ABUSE SCREENING
plus Alcohol
DOAL
DOA3
1,2
RU/CoC collection containers * See page 157 RU
DOAN DOAP
RU 2
B
AP ALCP
ABBG A A B B G RU
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
158 of collection. Turnaround times are quoted as working days.
Occupational health
OCCUPATIONAL HEALTH – TRACE METALS IN BLOOD
TEST CODE SAMPLE REQS TAT
TRAC
ABHK
Key: See page 23 for sample-taking and special handling instructions. 159
Occupational health
OCCUPATIONAL HEALTH – TRACE METALS IN URINE
TEST CODE SAMPLE REQS TAT
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
160 of collection. Turnaround times are quoted as working days.
Cervical Screening
The Cervical Cytology laboratory provides a rapid service for liquid based cervical samples.
Urine cytology is performed in house while other non-gynaecological cytology samples
are referred to a UKAS accredited laboratory for reporting.
Human papilloma virus (HPV), Chlamydia and Gonorrhoea testing is carried out routinely
from ThinPrep vials and can be requested at the time the cervical sample is taken.
Laboratory hours
The laboratory department is open between 9.00am and 6.00pm.
Out-of-hours results are available on 020 7307 7373.
Urgent samples
It is helpful if requests for urgent samples can be discussed with the Senior Management Team.
Please telephone 020 7307 7323 ext 4761.
The specimen container must be clearly labelled with patient details. Forms and samples which
are mismatched will result in the sample being returned to the sender for correction and will delay
the report turn around time.
Clinical advice
The Consultant Cytopathologists and the Advanced Practitioner work together to provide clinical and
technical advice, including recommendations for follow-up, HPV testing and management of complex
cases. TDL will provide recommendation for patient management, but not undertake to provide a
direct referral. No result will be entered onto the NHS CSP database and will therefore not be part
of an individual’s NHS screening record. Failsafe and management of the patient and their follow
up, including referral for colposcopy where indicated, would need to be arranged by their referring
clinician. To contact the department directly, please 020 7307 7323.
Key: See page 23 for sample-taking and special handling instructions. 161
Cervical Screening
RECORD…
…the patient’s 3 identifiers to include date of birth on the vial.
…the patient information and medical history on the cytology
requisition form.
OBTAIN…
…an adequate sample from the cervix using a Cervex Brush
(broom-like device). Insert the central bristles of the brush
into the endocervical canal deep enough to allow the shorter
bristles to fully contact the ectocervix. Push gently and rotate
the brush in a clockwise direction five times.
RINSE…
…the Cervex Brush immediately into the PreservCyt Solution
vial by pushing it into the bottom of the vial 10 times, forcing
the bristles apart. As a final step, swirl the brush vigorously to
further release material. Visually inspect the Cervex Brush to
ensure that no material remains attached. Discard the brush.
Do not leave the head of the Cervex Brush in the vial.
Check the vial is in date before use.
TIGHTEN…
…the cap so that the black torque line on the cap passes
the black torque line on the vial. Do not over-tighten.
PLACE…
…the vial and request form in a specimen bag for
transportation to TDL.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
162 of collection. Turnaround times are quoted as working days.
Cervical Screening
ThinPrep® PAP Test Cervex Brush Protocol
PREPARE ALL EQUIPMENT BEFORE STARTING THE PROCEDURE
• Note expiry date on sample collection vial. Do not use expired vials.
• Ensure the entire plastic seal is removed from the lid of the vial and discarded.
• Complete patient details on both the request form and the vial.
Specimens may be returned or discarded if details are missing from the vial.
• Remove the lid from the vial before taking the sample.
• Use of lubricant is NOT recommended.
DO DON’T
• If excessive mucus is present, this should • DO NOT leave the head of
be gently removed before sampling. the Cervex Brush in the vial.
• Use either the Cervex Brush (broom-like • DO NOT routinely clean the cervix
device) on its own or a Plastic spatula or take a cervical swab before taking
and endocervical brush combination. a cervical sample.
• The Cervex Brush should be rotated • An endocervical brush should never
5 times in a clockwise direction. be used in isolation.
The Plastic spatula should be rotated • DO NOT under any circumstances
through 360 degrees and the endocervical use a wooden spatula.
brush rotated through one quarter to
one half turn. • DO NOT leave the collection device sitting
in the vial whilst dealing with the patient.
• Immediately rinse the collected
material into the vial. • DO NOT over-tighten the lid on the vial.
• Replace the lid and tighten so that the • DO NOT place multiple labels
black torque line on the cap passes on the outside of the vial.
the black torque line on the vial to • DO NOT apply barcoded labels
avoid leakage. vertically on the vial.
• Keep the unlabelled portion of the • DO NOT use expired vials.
sample vial free of labels so that the • DO NOT delay the sending of vials to
contents can be seen. the laboratory. The sample needs to be
• If barcoded labels are used these must processed within 3 weeks of collection.
be applied horizontally around the vial. • DO NOT use excessive lubricant –
• Samples should be sent to the please AVOID if possible.
laboratory without delay.
Key: See page 23 for sample-taking and special handling instructions. 163
Cervical Screening
Gynaecological Samples
The Cytology department processes cervical samples directly referred from all sectors
of practice – Health Screening, Occupational Health, GP’s, Consultants, Colposcopy Units,
Clinics, Hospitals and other Laboratories.
Liquid Based Cytology (LBC) is processed using the Hologic ThinPrep system.
The Doctors Laboratory uses the Hologic Imaging system as an enhanced Quality Control.
Information for Sample Takers is available by contacting the department. Important: the head
of the cervical broom must NOT be left in the vial. The use of lubricant interferes with LBC sampling
and may result in an inadequate sample. Use of lubricant is NOT recommended as it can affect the
processing quality of the sample. Supplies of Thin prep vials are available from TDL.
STI Screening from Hologic Thin Prep Vial (HPV – see page 166)
Tests are priced individually. Please request tests individually. Thin Prep Vials are kept for 21 days
after receipt of sample. Requests for additional tests from the vial already received in the laboratory
can be made by contacting the Cytology Department.
PP12
TPV
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
164 of collection. Turnaround times are quoted as working days.
Cervical Screening
Human papillomavirus (HPV) is a common virus transmitted through sexual contact. High Risk sub-
types of HPV (HR-HPV) are linked to the development of abnormal cells and can cause cervical cancer.
HPV is a necessary cause of invasive cervical cancer. Evidence shows HPV testing is a more effective
way to identify women at risk of cervical cancer than by screening microscopically for abnormal cells
from a PAP test.
HR-HPV testing has been used in the UK since 2011 to identify women with low grade cytology
abnormalities and as a follow up test of cure in women who have received treatment. In 2017 the
UK NHSCSP recommended that testing for HPV should replace cytology as the first (primary test)
in cervical screening. Primary HR-HPV testing has higher sensitivity for high grade CIN than primary
cytology. HR-HPV testing also has a lower false negative rate than cytology. Primary HR-HPV testing
was fully implemented in the UK during 2020. Sample-taking remains unchanged: HR-HPV testing
is carried out from Thin Prep samples. Cytology will be undertaken as a triage if HPV is DETECTED.
https://www.gov.uk/government/publications/cervical-screening-primary-hpv-screening-
implementation/cervical-screening-implementation-guide-for-primary-hpv-screening
Key: See page 23 for sample-taking and special handling instructions. 165
Cervical Screening
UNDERSTANDING THE SIGNIFICANCE OF HPV TESTING
The benefit of a negative HPV result is its negative predictive value – meaning that a negative HPV
result indicates that a patient is at very low risk of developing cervical disease. However, neither HPV
testing nor negative cervical cytology are able to reduce the risk to zero. The negative predictive value
of both DNA and mRNA testing is the same. DNA tests detect presence of virus only. A mRNA test
detects the presence of viral oncogenic expression.
Requests for Cervical Cytology (PAPT) only will no longer be processed without HPV.
HPV testing will be charged.
Requests for PAPT
TEST CODE SAMPLE REQS TAT
Requests for HPV as the PRIMARY TEST will reflex to PAPT if HR-HPV is DETECTED/POSITIVE.
PAPT will NOT be charged.
TEST CODE SAMPLE REQS TAT
HPV (Individual low & high risk DNA subtypes) HP20 TPV / PCR Swab 3 days
HPV low and high risk DNA subtypes will be reported individually (9 low and 19 high risk).
If High Risk DNA subtypes are positive then cervical cytology (PAPT) using the same vial will be
processed without charge.
Requests for HPVT as a single test
TEST CODE SAMPLE REQS TAT
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
166 of collection. Turnaround times are quoted as working days.
Self-collection HPV samples
TDL Self-Collection HPV Test
Human Papillomavirus (HPV) is the primary cause of nearly all cervical cancer. In most cases,
the HPV virus is harmless and causes no symptoms. Most women who acquire HPV are able
to clear the infection through their own immune systems. Persistent presence of high-risk
types of HPV can cause cervical lesions which over time may develop into cancer if untreated.
Testing for HPV determines the presence, or absence, of HPV and will determine whether
the HPV type present is high risk for CIN and cervical cancer.
The Self Collection HPV Test provides women with the option to self-collect a vaginal specimen
that is then sent to the laboratory for testing. There is well documented high level of concordance
between the HPV DNA results from self-collected and clinician-collected specimens.
The Self-Collection HPV Test is validated, using a CE marked sample collection device for vaginal cell
collection. This sample is then sent to the laboratory for processing for 19 high risk HPV DNA subtypes.
A negative result means that these high-risk subtypes HPV were not detected and the patient is at
extremely low risk of developing high-grade cervical disease/CIN2+ before their next routine visit.
A positive HPV result might indicate an increased risk of developing CIN/cervical cancer,
and the report from the laboratory will provide a clear recommendation for follow-up/colposcopy.
The value of HPV DNA testing in cervical cancer screening and disease detection has been proven
over and over again. Self-collection of specimens for HPV testing is not intended to replace existing
patient management pathways but allows for:
• Those who wish to test following a change of sexual partner
• Option for identifying individual high risk DNA subtypes
• Personal preference to self-collect vaginal samples
• An acceptable option for women who avoid having regular cervical smears
• Self-collection for HPV increases acceptability and coverage rate of cervical cancer prevention
Results will always be sent to the requesting clinician, clinic or healthcare organisation.
HPVZ Self-Collected HPV DNA with individual reporting of all High Risk subtypes
(16, 18, 31, 33, 45, 35, 39, 51, 52, 56, 58, 59, 66, 68, 26, 53, 69, 73, 82).
For more information, or to order Self-Collection HPV Test Packs, please contact Annette Wilkinson
on 020 7307 7373 or [email protected]
HPV Individually Typed High Risk DNA Subtypes HPVZ Self-collection kit 10 days
HPV mRNA (All High Risk Subtypes) HPVY Self-collection kit 3 days
Key: See page 23 for sample-taking and special handling instructions. 167
Self-collection HPV samples
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
168 of collection. Turnaround times are quoted as working days.
Non-Gynae Cytology
Non-Gynaecological Cytology
Urines
To prevent cell degeneration it is advisable to collect urine samples in a sample pot containing
preservative (available from TDL Supplies). Use of preservative will ensure the cellular material
is preserved up to 48 hours.
Ideally 10 mls (excluding preservative) from a freshly fully voided urine (when the bladder is
emptied) mid-morning sample should be submitted for cytological assessment. If microbiology or
chemistry investigations are also required, please submit separate urine samples and mark the
vials accordingly. A mid-stream urine sample is NOT recommended for cytological assessment is
it could lead to a low cellular yield. If a delay of greater than 24 hours in reaching the laboratory
is anticipated samples should be refrigerated at 4°C.
Sputum
Sputum should be collected on at least three occasions if underlying lung carcinoma is suspected.
A single sputum is sufficient for microbiological assessment. Sputum should be sent to the laboratory
immediately following production, or stored in a universal container containing cytolyt cell fixative
if there is a likely delay. Please note that this is only acceptable if sputum is only for Cytology.
Microbiology cannot be performed on fixed material. Early morning sputum is ideal,
but contamination with food, toothpaste and tobacco should be avoided.
Fluids
All available material should be submitted in a sterile container without fixative as quickly
as possible. If any delay is anticipated, the material should be submitted in cytolyt fixative.
URINE/SPUTUM/FLUID
TEST CODE SAMPLE REQS TAT
Key: See page 23 for sample-taking and special handling instructions. 169
Histopathology
CATEGORY CODE TISSUE SAMPLE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
170 of collection. Turnaround times are quoted as working days.
Histopathology
CATEGORY CODE TISSUE SAMPLE
Key: See page 23 for sample-taking and special handling instructions. 171
Histopathology
CATEGORY CODE TISSUE SAMPLE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
172 of collection. Turnaround times are quoted as working days.
Histopathology
CATEGORY CODE TISSUE SAMPLE
Key: See page 23 for sample-taking and special handling instructions. 173
Histopathology
CATEGORY CODE TISSUE SAMPLE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
174 of collection. Turnaround times are quoted as working days.
Special instructions for samples
1 Contact the laboratory for special sample tubes/ 20 Sample types: FCRU or PCR swab or TPV
containers/instructions. or Semen.
2 Confirmation of not negative drug screens by 21 Urine cytology container, ideally first catch,
LCMS/MS may take up to 5 days. mid-morning specimen.
3 Clinical history essential and protect from light. 22 Must be fresh.
4 Send to the laboratory without delay. 30 Collect sample at end of exposure.
5 Do not send sample to the laboratory between 33 Sample must be labelled by hand with first
Friday noon and Monday morning. name, family name, gender and date of birth
6 Contact the Referrals Department before taking detailed on sample and form. Do not use labels
and sending sample to the laboratory. other than the tube label.
7 Sample should be separated and frozen if 34 Samples must arrive in the laboratory on the same
sending overnight. day of sample taking or contact the laboratory.
8 DRP Form required. DRP Form can be found 35 Patient should be fasting and resting for 30 mins
at the back of the guide. before sample taking. Samples need handling
urgently.
9 Clinical history must be provided.
36 Renin: Sample collected either upright /active
10 Contact the laboratory for special stability tubes or resting /supine (3 hours lying).
for lymphocyte subsets – or take an EDTA sample
and ensure same day delivery to the laboratory, 37 Provide sample time and date of collection.
Monday to Friday noon (do not send sample 38 EDTA sample should not be separated:
between Friday noon and Monday morning). send whole blood.
11 Patient consent required. Consent Form can 39 Urgent samples have a 3 day TAT if genotype is
be found at the back of this guide. required for prenatal diagnosis or two weeks TAT
12 Please provide one sample for each person if urgent for other factors.
being tested. 40 Informed Consent is required for these tests.
13 Protect from light. 41 Recommendation for patient to attend
14 Provide details of travel history. Patient Reception for sample taking.
15 Ammonia 42 LGV can be added to a positive chlamydia sample
using the same swab if requested within 4 days
Sample: EDTA plasma only. Full tubes and tightly
of receipt of result.
stoppered. On ice, centrifuged and analysed
20-30 mins post venepuncture (or plasma can 43 Please contact [email protected]
be frozen). If haemolysed gives falsely high results. for details for referring samples to the laboratory
Patient: Fasting. Avoid smoking. for sequencing testing.
16 Lactate
Example of profile panel information
Sample: Fluoride oxalate plasma only.
On ice and separate from cells 15-30 mins,
analyse promptly. Handle with care as sweat Profile PRE-TRAVEL SCREEN (DVT)
contains large amounts of lactate. No tourniquet. name
Patient: Rest 30 mins prior to test. FBC
17 Homocysteine Profile Factor II Prothrombin Gene
content Factor V Leiden
Should be spun and separated with 1 hour
Anticardiolipin TAT
of venepuncture.
Turnaround
Antibodies 5
18 Citrate Samples DAYS
time
Samples should be double spun and separated
and frozen within 4-8 hours of sample taking, DVT1
if a delay is expected with transportation to Sample
AAB9 Code
the laboratory, samples must be transported requirements
as frozen. Reference to sample taking and
special handling instructions (see above)
19 Must include patient’s age, height and weight.
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
of collection. Turnaround times are quoted as working days. 175
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
176 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 177
Alphabetical test index
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178 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 179
Alphabetical test index
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180 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 181
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
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182 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 183
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
184 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 185
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
186 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 187
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
188 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 189
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
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190 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 191
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
192 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 193
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
194 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 195
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
196 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 197
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
198 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 199
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
200 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 201
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
NEW RNA Polymerase Antibodies RNAP B 3 days 82
Rotavirus in Stool by PCR ROTA RF 1 day 99
RPR (VDRL) RPR B 2 days 68, 82
Rubella Antibody (IgG) RUBE B 4 hours 91, 99
Rubella Antibody (IgM) RUBM B 4 hours 91, 99
Rubella Avidity RUAV B 1 week 99
Rubella PCR RUBP A / Amniotic Fluid 5 days 91
S100 Malignant Melanoma S100 B 4 days 101
Saccharomyces Cerevisiae Antibodies ASCA B 2 weeks 82
Salicylates SALI B 4 hours 35
Salivary Duct Antibodies SAB B 12 days 82
Mid-morning terminal urine
Schistosoma (Urine) USCH 1-2 days 43
following exercise 14
Schistosome (Bilharzia) Antibodies BILH B 14 10 days 88
Scleroderma Immunoblot SCLI B 3 days 82
Screening Profile 1 – Biochemistry PP1 BG 4 hours 24
Screening Profile 2 – Haematology/
PP2 ABG 4 hours 24
Biochemistry
Screening Profile 3 – Haematology PP3 A 4 hours 24
Screening Profile 4 – Haematology/
PP4 ABG 4 hours 24
Biochemistry (Short)
Screening Profile 5 – Haematology/
PP5 ABG 4 hours 24
Biochemistry (Postal)
Screening Profile 6 – Well Person PP6 ABG 4 hours 24
Screening Profile 7 – Well Man PP7 ABG 4 hours 25
Screening Profile 8 – Well Person PP8 ABG 2 days 25
Screening Profile 9F – Senior Female PP9F A B B G RU QFIT 4 2 days 25
Screening Profile 9M – Senior Male PP9M A B B G RU QFIT 4 2 days 25
Screening Profile 10 –
PP10 BB 3 days 25
Cardiovascular Risk 1
Screening Profile 11 –
PP11 B B B C 34 3 days 25
Cardiovascular Risk 2
Screening Profile 12 –
PP12 FCRU / PCR / TPV 2 days 25
Sexual Health Screen
Seed Storage Proteins ZZ26 B 2 days 145
Selenium (Serum) SELE B 4 days 35, 148
Selenium (Whole Blood) SELR A or H 4 days 35, 148
Sellotape Test SELL Send Sample*** 1 day 43
Semen Analysis, Comprehensive* SPER Semen 1 2 days* 63
Semen Analysis, Post-Vasectomy** PVAS Semen 1 2 days 63
Semen Analysis, Vasectomy Reversal* SPER Semen 1 2 days* 63
Semen Culture SPCU Semen 2-4 days 43, 63
Semen Fructose SPCF Semen 2 days 63
Semen Leucocytes PMNS Semen 2 days 63
Semen Zinc SPCZ Semen up to 10 days 63
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
202 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 203
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
204 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 205
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
206 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 207
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Ensure all specimens and forms are labelled with given Forename, Surname, DOB, Date and Time
208 of collection. Turnaround times are quoted as working days.
Alphabetical test index
TEST CODE SAMPLE REQS TAT PAGE
Key: See page 23 for sample-taking and special handling instructions. 209
TDL Referral Laboratories
For certain specialist tests TDL has developed a selected network of TDL Group and Reference
Laboratories. These Group or specialist laboratories can be identified by a code assigned to reports.
The quality of these laboratories is recognised by UKAS, or similar accrediting bodies for the
laboratories outside the UK.
Addenbrooke’s Hospital – BGU and Immunology Guildford RSCH Trace Element Laboratory,
SAS Trace Element Centre
Affinity Biomarker Labs
HCA Healthcare UK – HCA Laboratories
Alder Hey Children’s NHS Foundation
Trust – Biochemistry Department Health & Safety Laboratory
Analytical Services International Ltd, St George’s HFL Sport Science (LGC Group)
University of London – Forensic Toxicology Service
Homerton University Hospital –
Animal and Plant Health Agency – Veterinary labs Department of Clinical Biochemistry
Antenatal Screening Service, Wolfson Institute Igenomix UK
of Preventive Medicine, Barts and The London
Imperial College Healthcare NHS Trust – Charing
School of Medicine and Dentistry
Cross Hospital, Chemical Pathology Department
Bio Predictive
Imperial College Healthcare NHS Trust – Charing Cross
Biodesix, Inc. Hospital, Infection and Immunity Department
Biolab Medical Unit Imperial College Healthcare NHS Trust – Charing
Cross Hospital, Medical Oncology
Bioscientia
Imperial College Healthcare NHS Trust – Hammersmith
Birmingham Children’s Hospital NHS
Hospital, Molecular Endocrinology
Foundation Trust – Clinical Chemistry
Imperial College Healthcare NHS Trust, St Mary’s Hospital
Brucella Reference Unit – Liverpool Clinical Laboratories,
– Virology Department
Royal Liverpool and Broadgreen Hospital
Independent Histopathology Services
Cambridge Clinical Laboratory
Institute of Aquaculture – University of Stirling
Cambridge Life Sciences
Institute of Neurology – Neurogenetics Unit
Cambridge Nutritional Science Ltd
Instituto Bernabeu Biotech
Cardiff and Vale University Health Board
– The Analytical Toxicology Department King’s College Hospital – HMDC Laboratory
for Molecular Haemato-Oncology
Cerba
Labor Augsburg MVZ GmbH
Chelsea and Westminister Hospital NHS Foundation Trust
Latis Scientific
CNC Forensic Toxicology Service Ltd
London School of Hygiene & Tropical Medicine
Douglass Hanly Moir Pathology
– Diagnostic Parasitology Lab
Epsom and St Helier University Hospital NHS
Matrix Diagnostics
Trust – Biochemistry Department
Mayo Clinic Laboratories
Epsom and St Helier University Hospital NHS
Trust – Immunology Department Meningococcal reference unit (Men RU) Manchester
– Manchester Royal Infirmary
Epsom and St Helier University Hospital NHS
Trust – Microbiology Department Micropathology Ltd
Eurofins – Biomnis, France National Blood Service – Colindale, Red Cell
Immuno Haematology Department
Great Ormond Street Hospital –
Department of Chemical Pathology NHS Blood and Transplant – Birmingham
Great Ormond Street Hospital – Enzyme NHS Blood and Transplant – H & I Laboratory
Unit, Chemical Pathology
NHS Blood and Transplant – Tooting
Great Ormond Street Hospital – Immunology Department
Norfolk and Norwich University Hospital NHS
Great Ormond Street Hospital – Neurometabolic Unit Foundation Trust – SAS Metabolic Bone Laboratory
Oxford Immunotec
210
TDL Referral Laboratories
Oxford University Hospital NHS Foundation Trust UCL Great Ormond Street Institute of Child Health
– Churchill Hospital
UCL Queen Square Institute of Neurology –
PHE – Bacteriology Reference Department (BRD), Department of Neuroimmunology
Colindale
University Hospital Birmingham NHS Foundation
PHE – Virus Reference Department (VRD) – Colindale Trust – Heartlands Hospital
PHE Mycology Reference Laboratory – PHE South University Hospital of Wales – Cardiff
West Laboratory, Southmead Hospital, Bristol Medical Immunology Department
PHE National Mycobacterium Reference Service Viapath – Guy’s Hospital, Biochemistry Genetics Laboratory
National Infection Service, Colindale
Viapath – King’s College Hospital, Clinical Biochemistry
PHE Rare and imported pathogens laboratory – Porton Down
Viapath – St Thomas’ Hospital Haemophilia Centre
Queens University Hospital, Belfast
Viapath – St Thomas’ Hospital Immunohistology
– Institute of Clinical Science
Viapath – St Thomas’ Hospital Purine Research Laboratory
Radboud University Nijmegen Medical Center
Randox Health – London
GROUP LABORATORIES
Reflab – Copenhagen
Royal Free London NHS Foundation Trust – Haemostasis
Reproductive Immunology Centre
University College London Hospitals NHS
Rosalind Franklin University
Foundation Trust (UCLH) – Cytology
Royal Berkshire Hospital NHS Foundation Trust
University College London Hospitals NHS Foundation
– Clinical Biochemistry
Trust (UCLH) – Hospital for Tropical disease
Royal Devon and Exeter NHS Foundation Trust
University College London Hospitals NHS Foundation
Royal Surrey County Hospital – SAS Peptide Hormone Section Trust (UCLH) – Molecular Virology
Sandwell and West Birmingham NHS Trust – City Hospital University College London Hospitals NHS Foundation
Birmingham, Clinical Biochemistry Department Trust (UCLH) – Special Chemistry
SCSA Diagnostics
Sheffield Children’s NHS Trust – Clinical Chemistry
Sheffield Teaching Hospital NSH Foundation Trust
– Protein Reference Laboratory Unit
and Immunology Department
Southmead Hospital – Antimicrobial
Reference Laboratory, Bristol
St George’s University Hospital NHS Foundation Trust
– Cell Marker Department
SYNLAB Laboratory Service – Abergavenny
The European Laboratory of Nutrients
The Leeds Teaching Hospital NHS Trust – Endocrinology
Laboratory (including SAS Steroid Centre), Department of
Specialist Laboratory Medicine, St James University Hospital)
The Leeds Teaching Hospitals NHS Trust
– Mycology Reference Centre
The Newcastle upon Tyne Hospitals – Royal Victoria Infirmary
The Royal Marsden Hospital – Department
of Haematology / Oncology
The Royal Marsden Hospital – Department of Pathology
Toxoplasma Reference Unit, Public Health Wales
Microbiology ABM, Singleton Hospital – Swansea
Trace Laboratories Ltd
211
TDL Genetics Referral Laboratories
All Wales Medical Genetics Service Protein Reference Unit & Immunology
Department – Sheffield Protein Unit
Anthony Nolan, Histocompatability and Immunogenetics
Purine Research Laboratory – St Thomas’ Hospital
Asper Biotech
Royal Marsden – Haemato-Oncology Unit
Bioscientia GmBH
Sheffield Diagnostic Genetics Service
Bristol Genetics Laboratory (North Bristol NHS Trust)
SIHMDS – Cytogenetics Laboratory,
CentoGene
Great Ormond Street Hospital
DiaGenom GmbH
South East Scotland Genetics Service (NHS Lothian)
Douglass Hanly Moir Pathology
South West Thames Regional Genetics Service
East Scotland Regional Genetics Service (NHS Tayside)
SYNLAB Budapest Diag Center
Exeter Clinical Laboratory – Department of Molecular Genetics
The Leeds Genetics Laboratory Viapath Analytics LLP
Fulgent Diagnostics
Wessex Region Genetics Service
Institute of Neurology, Queen’s Square
West Midlands Regional Genetics Laboratory
International Blood Group Reference Laboratory
West of Scotland Genetic Service
London South East Genetics Service (NHS Greater Glasgow and Clyde)
Medical Genetics Laboratory – Central Manchester
University Hospitals NHS Foundation Trust
Medical Neurogenetics Laboratory LLC
Micropathology Ltd
Molecular Genetics Laboratory – Liverpool’s
Women NHS Foundation Trust
Molecular Vision Laboratory
Newcastle Mitochondrial NGC Diagnostic Service
North East Thames Regional Genetic Service
North West London Pathology
North West Thames Regional Genetic Service
Northern Genetics Service
Oxford Genetics Laboratory – Oxford University Hospitals
Prevention Genetics
Progenika Biopharma Grifols
212
Terms & Conditions of Business from 1st Jan 2022
The definitions which apply to these Terms 1.7 TDL may destroy or dispose of a Sample after
and Conditions are set out in clause 18. completing the Testing or on termination
of the Agreement, unless otherwise
1 THE SERVICES agreed in writing with the Client.
1.1 These Terms and Conditions will apply to any services 1.8 The Consumables shall remain the property
that TDL provides to the Client, unless those services of TDL at all times, regardless of any use
are the subject of a separate written agreement signed by the Client of the Consumables.
by TDL and the Client. These Terms and Conditions 1.9 In providing the Services, TDL shall comply with
apply to the exclusion of any other terms presented by all Applicable Law relating to anti-bribery and
the Client or implied by custom or course of dealing. anti-corruption, including the Bribery Act 2010.
1.2 By submitting a request for any services described TDL shall not, and shall ensure that its staff do
in the Laboratory Guide or in any other proposal not, engage in any activity which would constitute
provided by TDL (an ‘Order’), the Client offers an offence under the Bribery Act 2010.
to purchase those services on these Terms and 1.10 TDL is committed to trading ethically, with zero
Conditions. A contract between TDL and the Client for tolerance for modern slavery (including forced
the provision of services incorporating these Terms and labour or human trafficking of any kind), human
Conditions (an ‘Agreement’) takes effect when TDL rights violations, and child labour. In performing its
confirms acceptance of the Client’s Order in writing, obligations under this Agreement, TDL will comply
logs the relevant Pathology Request in its laboratory with all Applicable Law and applicable internal policies
information management system, or begins performing relating to anti-slavery and human trafficking.
the Services (whichever occurs first). Any request for 1.11 TDL’s laboratories are operated by members of the
add-on Tests (as described in the Laboratory Guide) TDL Group. TDL uses those laboratories to undertake
constitutes a request for further Services under that the Tests, except where TDL refers the Tests to
Agreement, which TDL may accept or decline. suitably accredited laboratories operated outside
1.3 TDL will provide the Services under the Agreement: the TDL Group. The UKAS accreditation numbers for
1.3.1 in accordance with Good Industry Practice; the TDL Group laboratories in the UK are as follows:
8059 (HSL Analytics LLP) Genetics and Molecular
1.3.2 in accordance with the UKAS medical laboratory
Sciences, 8169 (HSL Analytics LLP) Blood Sciences,
accreditation standard (ISO 15189); and
8860 (HSL Analytics LLP) Infection Sciences, 8812
1.3.3 using suitably skilled and experienced staff. (The Doctors Laboratory Limited) Haematology, Blood
1.4 TDL will use reasonable efforts to achieve the Test Transfusion, Biochemistry, Microbiology, Molecular
turnaround times quoted in the Laboratory Guide, Biology, 10199 (The Doctors Laboratory Limited)
but does not warrant that it will achieve those Andrology, 8511 (HSL Analytics LLP) Cytology, 9706
times in the case of any particular Sample. (The Doctors Laboratory Limited) Urine Cytology.
1.5 The Laboratory Guide sets out Sample rejection criteria.
If the Sample meets those criteria, or if TDL considers 2 PRICE AND PAYMENT TERMS
that the Sample is otherwise unsuitable for Testing or 2.1 The fees payable by the Client for the Services
TDL is unable to conduct the Testing then TDL may will be the most recent price confirmed by TDL
decline to carry out the Testing under the Agreement to the Client in writing or by telephone prior to
and will be entitled to dispose of the Sample. the Client submitting its Order. If TDL has not
1.6 As part of its Services TDL will, on request, arrange for confirmed the price for the Services, the price
collection of Samples from locations within the M25 will be that indicated in the Laboratory Guide.
motorway. Such collection service is included within 2.2 As at the date of these Terms and Conditions many of
the price of the Test unless otherwise specified by TDL. TDL’s services are VAT exempt. All of TDL’s prices are
Collection of Samples from locations outside the M25 stated exclusive of VAT and where VAT is chargeable on
is by special arrangement, and may incur an additional the Services the Client will pay it at the applicable rate.
charge. Where collection by TDL has not been
requested and agreed, the Client will be responsible,
at its own cost, for the transport of Samples to TDL.
Where TDL arranges collection of Samples it will use
reasonable efforts to achieve the timescales it quotes
for collection, but does not warrant that it will achieve
those timescales in the case of any particular collection.
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2.3 Invoices are normally issued on a monthly basis, but 4.2 Except where TDL agrees to arrange transport
TDL reserves the right to issue them more frequently. of the Sample to TDL’s laboratory, the Client will
The client will pay TDL’s invoices under the Agreement ensure that the Sample is transported to TDL’s
within 30 days of the date of the invoice, without any laboratory in accordance with Applicable Law
deduction or set off. At TDL’s option interest may and good clinical practice. Where TDL agrees to
be charged on late payment at the statutory rate arrange transport of the Sample the Client will
prescribed from time to time by regulations under the ensure that the Samples are ready for collection
Late Payments of Commercial Debts (Interest) Act 1998. by TDL or its carrier at the agreed times.
Invoices paid from outside the UK must be paid by 4.3 The Client will ensure that all necessary consents
either direct bank transfer or by cheque drawn on a UK and permissions are obtained and all necessary
branch. All payments will be made in pounds sterling. information provided to the patient, which is required
2.4 Without affecting any of its other rights, TDL under Applicable Law or good clinical practice in
may suspend provision of the Services if the order to permit the Testing, the performance of and
Client fails to pay an invoice due to TDL. any other Services, and the use of the Protected
Data as contemplated in the Agreement.
3 CONFIDENTIALITY 4.4 The Client will provide TDL with any information
3.1 TDL agrees that it will hold and reasonably necessary for performing the Services,
maintain the confidence of: including by ensuring that the Pathology Request
contains sufficient information regarding the Sample,
3.1.1 all information of a confidential nature which is
the relevant patient, and the persons to whom the Test
received by TDL from the Client or its patients
results are to be reported, and will ensure that any
in connection with the Services; and
information the Client provides to TDL in connection
3.1.2 all Test results, invoices and other information of a with the Services is accurate and complete.
confidential nature issued by TDL to the Client or
4.5 The Client shall ensure that any Consumables provided
its patients in connection with the Services, and,
by TDL are only used by healthcare professionals
save with the Client’s consent or as otherwise
who are appropriately qualified and trained in
permitted under this Agreement, will not disclose
the proper use of such Consumables. The Client
such information other than to its professional staff,
shall ensure the healthcare professionals use the
independent consultants and/or persons to whom
Consumables in accordance with any instructions
it has delegated the performance of the Services
relating to the use of the Consumables provided by
and who require the information for such purpose.
TDL and in any event with the degree of skill and care
Where TDL has been provided with the details of a
reasonably to be expected of a healthcare professional
patient’s private medical insurance in connection
experienced in the use of such Consumables.
with the Services, TDL will be entitled to assume
(and the Client so warrants) that both the Client and
the patient consent to the disclosure of information 5 LIABILITY
relating to that patient to the insurer concerned. 5.1 Nothing in the Agreement will limit or exclude
3.2 The restrictions in clause 3.1 will not apply to liability for death or personal injury caused by
information which: (i) was in TDL’s possession prior negligence or any other liability that cannot be
to disclosure by the Client; or (ii) is now or hereafter limited or excluded under Applicable Law.
comes into the public domain other than by default 5.2 In these Terms and Conditions ‘liability’ means any
of TDL; or (iii) was lawfully received by TDL from a liability whether in contract, tort (including negligence),
third party acting in good faith having a right of further misrepresentation, breach of statutory duty or
disclosure; or (iv) is required by law to be disclosed otherwise, which arises in connection with the Services
by TDL; or (v) which is required by a regulatory or under or in connection with any Agreement.
or accreditation body to be disclosed to it for the 5.3 The liability of TDL and the Client will each
purpose of regulating or accrediting the TDL Group. be limited to £2,000,000 in total. This limit
applies per Agreement and in aggregate for
4 CLIENT RESPONSIBILITIES all Agreements made in a calendar year.
4.1 Except where TDL obtains the Sample directly 5.4 Neither TDL nor the Client will have any liability for:
from the patient during a home visit or at TDL’s 5.4.1 loss of profit or revenue;
patient reception facility, the Client will ensure
that the Sample is obtained from the patient, 5.4.2 loss of anticipated savings;
packaged, and labelled in accordance with 5.4.3 loss of reputation or goodwill; or
Applicable Law and good clinical practice. 5.4.4 indirect, special or consequential loss.
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5.5 TDL will have no liability for any delay or failure 8 DATA PROCESSING INSTRUCTIONS
in performance of the Services arising from the
8.1 When TDL processes Protected Data as the data
Client’s delay or failure in performing its obligations
processor, TDL will comply with the obligations of
under clause 4 (Client Responsibilities).
data processors under Data Protection Laws.
5.6 All of the warranties which TDL gives in relation
8.2 Unless required to do otherwise by Applicable
to the Services are expressly set out in these
Law, TDL will (and will take steps to ensure each
Terms and Conditions. All other warranties,
person acting under its authority will) process
whether implied or express, are excluded from the
the Protected Data only in accordance with the
Agreement where it is lawful to exclude them.
Client’s documented instructions as set out in the
5.7 In this clause 5 references to TDL include the Order, pursuant to the Terms & Conditions, and
members of TDL’s Group, and for the purpose of the in the Annex (the ‘Processing Instructions’).
limit in clause 5.3 the liabilities of TDL and the TDL
8.3 If Applicable Law requires TDL to process Protected
Group Members will be counted in aggregate. The
Data other than in accordance with the Processing
members of TDL’s Group may enforce this clause 5.
Instructions, TDL will notify the Client of any such
requirement before processing the Protected Data
6 FORCE MAJEURE (unless Applicable Law prohibits TDL from doing so).
If the performance of any obligation under the 8.4 TDL will promptly inform the Client if TDL becomes
Agreement (except for an obligation to pay) is prevented, aware of a Processing Instruction that, in TDL’s
restricted or interfered with by reason of circumstances opinion, infringes Data Protection Laws. TDL will
beyond the reasonable control of that party obliged have no liability for any processing in accordance
to perform it (a ‘Force Majeure Event’), the party so with those Processing Instructions after giving the
affected will be excused from any resulting failure or notice. TDL’s obligations under this clause 8.4 do
delay in performance, and the time for performance not limit the Client’s obligations under clause 7.3.
will be extended by an amount of time equal to the
duration of the Force Majeure Event. The party so
9 DATA SECURITY MEASURES
affected will use reasonable endeavours to mitigate the
effect of the Force Majeure Event on its performance In relation to the processing of the Protected Data,
of its obligations. If the Force Majeure Event delays TDL will implement and maintain, at its cost and
or prevents performance of a party’s obligations for expense, appropriate technical and organisational
more than three months, either party may terminate measures to ensure for the Protected Data a level
the agreement on written notice to the other. of security appropriate to the risks presented by the
processing, taking into account the state of the art,
the cost of implementation and the nature, scope,
7 DATA PROCESSOR
context and purpose of the processing of the Protected
AND DATA CONTROLLER
Data as well as the risk of varying likelihood and
7.1 When TDL processes Protected Data on behalf severity of the rights and freedoms of natural persons.
of the Client in providing the Services the parties
agree that the Client will be the data controller and
10 USING STAFF AND OTHER PROCESSORS
TDL will be the data processor. The Annex to these
Terms and Conditions sets out when TDL processes 10.1 TDL will not engage any data processor to process
Protected Data on behalf of the Client. Clause 16 the Protected Data on the Client’s behalf (a ‘Sub-
describes the circumstances where TDL will use Processor’) without the Client’s authorisation of that
Protected Data on its own behalf as data controller. specific Sub-Processor. The Client will not unreasonably
withhold, condition or delay such consent. By accepting
7.2 When TDL processes Protected Data as the data
these Terms and Conditions the Client authorises the
processor, clauses 8 to 15 will apply in relation to
appointment of the Authorised Sub-Processors.
the Protected Data. Where TDL processes Protected
Data as data controller, clause 16 will apply instead. 10.2 TDL will ensure that each Sub-Processor is appointed
under a written contract containing materially the
7.3 The Client will comply with the Data Protection
same obligations as clauses 8 to 15 (inclusive).
Laws in relation to the Protected Data, and
ensure that all instructions given by it to TDL 10.3 TDL will ensure that all persons authorised to process
in respect of Protected Data will at all times be Protected Data are subject to a binding obligation to
in accordance with Data Protection Laws. keep the Protected Data confidential (except where
disclosure is required in accordance with Applicable
Law, in which case TDL will, where practicable and
not prohibited by Applicable Law, notify the Client
of any such requirement before such disclosure).
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Terms & Conditions of Business from 1st Jan 2022
11 ASSISTANCE WITH THE CLIENT’S 13.2 TDL will, in accordance with Data Protection Laws,
COMPLIANCE AND DATA SUBJECT RIGHTS make available to the Client such information as is
reasonably necessary to demonstrate TDL’s compliance
11.1 Taking into account the nature of the processing,
with its obligations as a data processor under these
TDL will implement and maintain reasonable
Terms and Conditions and the Data Protection Laws,
measures to assist the Client to respond to the
and allow for and contribute to audits, including
Data Subject Requests relating to the Protected
inspections, by the Client (or another auditor mandated
Data that TDL processes on the Client’s behalf.
by the Client) for this purpose, subject to the Client:
TDL will refer such Data Subject Requests it receives
to the Client promptly, and in any event within 13.2.1 giving TDL reasonable prior notice of such information
five Business Days of receipt of the request. request, audit and/or inspection being required
by the Client;
11.2 TDL will provide such assistance as the Client
reasonably requires (taking into account the nature 13.2.2 ensuring that all information obtained or generated
of processing and the information available to by the Client or its auditor(s) in connection with such
TDL) to the Client in ensuring compliance with the information requests, inspections and audits is kept
Client’s obligations under Data Protection Laws strictly confidential (save for disclosure to the relevant
with respect to: (i) security of processing, (ii) data regulator or as otherwise required by Applicable Law);
protection impact assessments (as such term is 13.2.3 ensuring that such audit or inspection is undertaken
defined in Data Protection Laws), (iii) prior consultation during normal business hours, with minimal disruption
with the relevant regulator regarding high risk to TDL’s business, the Sub-Processors’ business
processing, (iv) and notifications to the regulator and/ and the business of other customers of TDL.
or communications to data subjects by the Client in
response to any Personal Data Breach. The Client
14 BREACH NOTIFICATION
will pay TDL’s charges for providing the assistance
in this clause 11, such charges to be calculated TDL will, without undue delay notify the Client
on a time and materials basis at TDL’s applicable of the Personal Data Breach involving the
daily or hourly rates in force from time to time. Protected Data, and provide the Client with
details of the Personal Data Breach.
12 INTERNATIONAL DATA TRANSFERS
15 DELETION OR RETURN OF
The Client agrees that TDL may transfer Protected
PROTECTED DATA AND COPIES
Data to countries outside the United Kingdom for
the purpose of providing the Services, provided all TDL will, at the Client’s written request, either delete
transfers by TDL of Protected Data to such recipients or return all of the Protected Data to the Client in
are in accordance with such safeguards or other such form as the Client reasonably requests within
mechanism(s) for transfers of personal data as may a reasonable time after the end of the provision of
be permitted under Data Protection Laws from time to the relevant Services related to processing, and
time. The Client agrees that TDL may implement such delete existing copies (unless storage of any data is
safeguards by entering into standard data protection required by Applicable Law and, if so, TDL will inform
clauses authorised under the Data Protection Laws, the Client of any such requirement). Where TDL will
which TDL may do as agent on behalf of the Client. process that Protected Data as data controller under
The provisions of clauses 8 to 15 (inclusive) will clause 16, TDL may retain the Protected Data.
constitute the Client’s instructions with respect to
transfers in accordance with clause 8.2. 16 PROTECTED DATA THAT TDL
PROCESSES AS A DATA CONTROLLER
13 RECORDS, INFORMATION AND AUDIT 16.1 TDL may process Protected Data as data controller
13.1 TDL will maintain, in accordance with Data in the circumstances and for the purposes set out
Protection Laws binding on TDL, written in TDL’s Privacy Notice. In particular TDL may:
records of all categories of processing activities 16.1.1 retain and submit Protected Data to a Health
carried out on behalf of the Client. Authority in the United Kingdom for the purposes
of a Public Health Programme operated by that
Health Authority, or to regulator for the purpose
of complying with regulatory obligations; and
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Terms & Conditions of Business from 1st Jan 2022
16.1.2 retain and process Protected Data in its laboratory 17.3 Rights and waiver
records in order to meet the requirements of the All rights granted to either of the parties will be
UKAS medical laboratory accreditation standard cumulative and not exhaustive of any rights and
(ISO 15189) and implement the guidelines of the remedies provided by law. The failure of either
Royal College of Pathologists for the retention and party to enforce (or delay in enforcing) at any time
storage of pathological records and specimens. for any period any one or more of the terms of this
16.3 When TDL processes Protected Data to Agreement will not be a waiver of such term or of
provide Harmony® Non-Invasive Prenatal the right of such party at any time subsequently
Tests, TDL does so as a data controller. to enforce all the terms of this Agreement.
16.4 When TDL processes personal data on its own behalf 17.4 Severability
as data controller, it will do so in accordance with the If any provision of this Agreement is or becomes
obligations of data controllers under Data Protection invalid, illegal or unenforceable in any respect under
Laws and with the applicable terms of the Agreement. any law, the validity, legality and enforceability of the
remaining provisions will not be in any way affected.
17 GENERAL 17.5 Sub-contracting and Assignment
17.1 Dispute resolution TDL may assign or sub-contract the performance
17.1.1 If any dispute arises relating to this Agreement or of this Agreement (in whole or in part) or any one
any breach or alleged breach of this Agreement, or more of the Tests to be performed hereunder to
the parties will make a good faith effort to resolve suitably accredited laboratories including those listed
such dispute without recourse to legal proceedings. in the Laboratory Guide. The Client may not assign
If, notwithstanding such good faith efforts, the this Agreement or any of its rights or obligations
dispute is not resolved either party may submit the hereunder without the prior approval of TDL.
dispute to the jurisdiction of the English Courts. 17.6 Relationship of the parties
17.1.2 Except to the extent clearly prevented by the area It is acknowledged and agreed that TDL and the
of dispute, the parties will continue to perform Client are independent contractors and nothing in this
their respective obligations under this Agreement Agreement will create or be construed as creating a
while such dispute is being resolved. partnership or (except as provided in clause 12 and the
17.2 Variation Annex) a relationship of agent and principal between
17.2.1 TDL may amend these Terms and Conditions by the parties. The Client acknowledges and agrees that, in
updating the Laboratory Guide and providing the requesting Services from TDL, it is not acting as agent
Client with a copy of the update or publishing it on for any patient or patients to which the Services relate.
TDL’s website. Such amendments will only apply 17.7 Notices
to an Order submitted after the date of the update, All notices given under this Agreement will be in
and the Client will be deemed to accept those writing and will be delivered by hand or sent by prepaid
amendments by submitting an Order after that date. first class post or by prepaid first class recorded
17.2.2 Except as set out in clause 17.2.1, any amendments delivery or by email transmission. All notices will be
to this Agreement will not be effective unless in writing delivered at or sent, in the case of TDL, to The Halo
and signed by an authorised signatory on behalf of Building,1 Mabledon Place, London WC1H 9AX, email
each of the parties. The terms of this Agreement [email protected] and, in the case of the Client
may be varied by agreement of the parties but to the address and/or email address set out in the Order
without the consent of any third party whether or not (or such other address as that party will notify in writing
the rights of such third party are affected by such to the other for this purpose). A notice sent by post
variation. The Client will not unreasonably withhold, will be deemed to be served at 9.00 am on the second
delay or condition its agreement to any variation to Business Day following the date of posting; a notice
this Agreement requested by TDL in order to ensure sent by email transmission will (provided the sender
the Services and TDL (and each Sub-Processor) receives no error message indicating that delivery has
can comply with any change in Applicable Laws. been unsuccessful) be deemed to have been served at
the time it is transmitted if transmitted within business
hours (9.00 am to 6.00 pm) on a Business Day or, if
transmitted outside such business hours on a Business
Day or on a day which is not a Business Day as soon
thereafter as such business hours commence.
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Terms & Conditions of Business from 1st Jan 2022
17.8 Entire agreement ‘controller’, ‘data subject’, ‘personal data’,
The Agreement is set out in the Order and these ‘process’ and ‘processor’ have the meanings
Terms and Conditions, which together set out the given to those terms in Data Protection Laws;
entire contract between the Client and TDL relating ‘Consumables’ means any goods provided by TDL
to their subject matter. In the event of a conflict in order for the Client to benefit from the Services;
between the Order and these Terms and Conditions, ‘Data Protection Laws’ means the UK GDPR,
the Terms and Conditions will take priority. Each the Data Protection Act 2018, and any other
party acknowledges that it has not entered into the Applicable Law having effect in the United Kingdom
Agreement in reliance on, and will have no remedies concerning privacy or the use of personal data;
in respect of, any representation or warranty that
is not expressly set out in the Agreement except ‘Data Subject Request’ means a request made
in the case of fraudulent misrepresentation. by a data subject to exercise any rights of
data subjects under Data Protection Laws;
17.9 Third parties
‘Good Industry Practice’ means the standard of
The Agreement is not intended to create any skill and care reasonably to be expected from
rights for, nor be enforceable by, any third a professional provider of the Services;
party except as set out in clause 5.
‘Group’ in respect of any undertaking, means
17.10 Governing law such undertaking and its group undertakings
The Agreement and any dispute arising out (‘undertaking’ and ‘group undertaking’ having the
of or in connection with it (including non- meanings given in the Companies Act 2006);
contractual disputes and claims) will be governed ‘Health Authority’ means (i) a department of the
by and construed in accordance with English UK government or of a devolved administration, (ii)
law and each of the parties submits to the an executive agency of such department, or (iii) a
exclusive jurisdiction of the English Courts. body exercising statutory functions in relation to
public health in the UK or any part of the UK;
18 INTERPRETATION ‘Laboratory Guide’ means TDL’s Laboratory Guide
18.1 In these Terms and Conditions and the Annex:- current at the time the Client submits the Order,
‘Agreement’ has the meaning given in clause 1.2; as supplied to the Client or, if not so supplied,
available on request from TDL, including any
‘Annex’ means the annex to the Terms and Conditions;
updates or supplements issued by TDL;
‘Applicable Law’ means the laws, regulations,
‘Order’ has the meaning given in clause 1.2;
judgments, binding on the relevant party,
as amended from time to time; ‘Pathology Request’ means an Order requesting Testing;
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Terms & Conditions of Business from 1st Jan 2022
‘Public Health Programme’ means a programme ANNEX
administered by a Health Authority to monitor
1 Subject matter and nature of processing
or analyse health data for the purpose of
public health or for statistical, scientific or 1.1 TDL processes Protected Data as data processor
research purposes in the public interest; on behalf of the Client:
‘Sample’ means a sample provided by the Client 1.1.1 in the case of Testing, when TDL receives a Pathology
to TDL for Testing; Request and Sample and processes the corresponding
Protected Data to carry out the Test and report
‘Services’ means the services to be
the Test results in accordance with the
provided under the Agreement;
Client’s documented instructions;
‘Sub-Processor’ has the meaning given in clause 10.1;
1.1.2 when TDL carries out the Client’s ‘fee to patient’
‘TDL’ means The Doctors Laboratory Limited instructions, as described below; and
or such other member of the TDL Group as
1.1.3 in the case of any other Services, when TDL is required
has agreed to provide the Services;
to process the Protected Data on the Client’s behalf
‘TDL Group’ means The Doctors Laboratory Limited to fulfil the Client’s instructions.
and its Group and Health Service Laboratories LLP
1.2 The subject matter and nature of TDL’s processing
and its Group;
of the Protected Data are:
‘Test’ means a laboratory test to be carried out by
1.1.1 pathology samples and test results for the purpose
TDL on a Sample, and ‘Testing’ means the process
of providing clinical pathology services;
of conducting that Test and reporting the results;
1.1.2 information about clinicians who order
‘UKAS’ means the United Kingdom Accreditation
pathology tests, for the purposes of
Service, or any successor to it;
reporting the test results to the Client;
‘UK GDPR’ has the same meaning as it does
1.1.3 information about a patient’s health insurance for the
in section 3(10) of the Data Protection Act
purposes of administering payment for the Services; and
2018, read with section 205(4) of that Act.
1.1.4 billing information for a patient where the Client has
18.2 References to the singular include the plural
asked TDL to direct TDL’s invoice to the patient.
and vice versa.
18.3 Clause headings and paragraph headings are for 2 Duration of processing
ease of reference only and are not part of these The duration of the processing is the time necessary
Terms and Conditions for the purpose of construction. to carry out the Services.
18.4 References to paragraphs are to paragraphs 3 Types of personal data
of the Annex.
3.1 The Protected Data comprise the following types
18.5 Words following the terms ‘including’, ‘include’, of personal data:
‘in particular’, ‘for example’ or any similar expression
shall be construed as illustrative and shall not limit 3.1.1 Name
the sense of the words, preceding those terms. 3.1.2 Gender
18.6 The Annex is incorporated into these Terms 3.1.3 Date of birth
and Conditions. 3.1.4 Address
3.1.5 Identity numbers assigned by TDL or the Client
3.1.6 Types of pathology tests conducted
3.1.7 Results of pathology tests
3.1.8 Health insurance policy details
3.1.9 Billing information
3.1.10 The types of data referred to in the
TDL Laboratory Guide
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Terms & Conditions of Business from 1st Jan 2022
4 Categories of data subjects
The Protected Data concerns patients in respect
of whom TDL conducts pathology tests, and
clinicians who request pathology tests.
6 Fee to patient
Where the Client selects the ‘fee to patient’ option in
a Pathology Request Form, the Client instructs TDL to
seek payment from the patient of the fees owed by the
Client in respect of that test. The Client confirms that
the patient has agreed with the Client to pay those fees
to TDL for the Client. The Client instructs TDL to recover
the fees by invoicing the patient using the personal
data provided by the Client. The Client instructs TDL on
the Client’s behalf to appoint debt collectors to recover
the fees from the patient if the patient does not pay
the invoice by the date payment falls due. The Client
authorises TDL to appoint those debt collectors as
Sub-Processors in accordance with clauses 8 to 15.
220
SAMPLE
TYPES
Vacutainer Anticoagulant Capacity
Lavender EDTA 4ml / 10ml* A
Gold SST/Gel 5ml B
Light Blue Citrate 4.5ml C
Red None 6ml F
Grey Fluoride oxalate 2ml, 4ml G
Green Lithium heparin 6ml H
Dark Blue Sodium heparin 7ml K
* 10ml EDTA tubes are used for specific PCR assays
Random Faeces RF
Faecal Collection LF
Random Urine RU
Mid Stream Urine MSU
First Catch Random Urine (for DL12/Chlamydia, etc.) FCRU
30ml aliquot from a 24 hour urine collection – state total volume CU
30ml aliquot from a 24 hour urine collection with 10ml of
0.1N Hydrochloric Acid added – state total volume PU
Early Morning Urine (1st sample of the day) EMU
60ml container (sterile) SC
Cytyc Thin Prep Vial TPV