LINK1041 Operators Manual

Inova Diagnostics, Inc.
QUANTA Link®
4.1
Operators Manual
IMPORTANT: Please read carefully before using
QUANTA Link® Software Program
Document Number: LINK1041

ECO Number: 516015
Effective Date: 04/02/20
9900 Old Grove Road
San Diego, CA 92131
United States of America
Technical Service (U.S. & Canada Only):+1-877-829-4745
Technical Service (Outside the U.S.): +1-858-805-7950
[email protected]
Inova reserves the right to make technical improvements to this equipment and documentation
without prior notice as part of a continuous program of product development. This manual
supersedes all previous editions. Information in this document is subject to change without notice.
Copyright © 2020 Inova Diagnostics, Inc. All rights reserved. This document is the copyright of
Inova, Inc. and must not be copied or reproduced in any form without prior consent.
QUANTA Link® 4.1
Operators Manual
IMPORTANT: Please read carefully before using

QUANTA Link® Software Program
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Table of Contents
CHAPTER 1: Intended Use ........................................................... 8
1.1 Intended Use ........................................................................................ 8
1.2 Product description ............................................................................ 8
1.3 Software description ........................................................................... 8
1.4 Hardware description ......................................................................... 9

CHAPTER 2: Pre-installation .................................................... 10
2.1 Electrical requirements .................................................................... 10
CHAPTER 3: Principles of Operation ........................................ 11
3.1 Configuration ..................................................................................... 11
CHAPTER 4: Performance Characteristics and Specifications
...................................................................................................... 13
4.1 Electrical power................................................................................. 13
4.2 Electrical requirements .................................................................... 13
4.3 Power consumption .......................................................................... 13
4.4 Instrument noise ............................................................................... 13
4.5 Physical Specifications .................................................................... 13

CHAPTER 5: Overview of User Interface ................................. 14
5.1 QUANTA Link log-in.......................................................................... 14
5.2 QUANTA Link functional areas ........................................................ 15

5.2.1 Color codes and icons ........................................................................................ 17
5.3 QUANTA Link dashboard reference area ....................................... 18
5.4 IFA reagent area ................................................................................ 19
5.5 EIA reagent area ................................................................................ 20
5.6 CIA reagent area................................................................................ 21
5.7 Connections Screen ......................................................................... 22
5.8 Orders ................................................................................................ 23
5.9 Sample bank ...................................................................................... 27
5.10 QC Management Area ....................................................................... 32
5.11 Atlas reference area .......................................................................... 33
5.12 Common operator actions ............................................................... 34

5.12.1 User Information.................................................................................................. 34
5.12.2 Settings ................................................................................................................ 34
5.12.3 Search .................................................................................................................. 36
5.12.4 Statistics .............................................................................................................. 37
5.12.5 Minimize ............................................................................................................... 37
5.12.6 Exit ....................................................................................................................... 37
CHAPTER 6: Operating Instructions ........................................ 38

6.1 Logging in .......................................................................................... 38
6.2 Navigation buttons............................................................................ 39
6.3 Dashboard functional area ............................................................... 39

6.3.1 Status by reagent ................................................................................................ 39
6.3.2 Status summary .................................................................................................. 40
6.3.3 Test status ........................................................................................................... 40
6.3.4 Positive results .................................................................................................... 41
6.4 IFA Section ........................................................................................ 42

6.4.1 IFA pending list ................................................................................................... 42
6.4.2 IFA status list ....................................................................................................... 45
6.4.3 IFA Legend........................................................................................................... 46
6.4.4 Order filter............................................................................................................ 48
6.4.5 IFA Sessions........................................................................................................ 50
6.4.6 Connections ........................................................................................................ 77
6.4.7 IFA workflow ........................................................................................................ 79
6.5 EIA/CIA/Aptiva Sections ................................................................... 83
6.5.1 Worklists .............................................................................................................. 84
6.5.2 Tests..................................................................................................................... 87
6.5.3 EIA/CIA/Aptiva workflow ..................................................................................... 89
6.6 QC Overview ...................................................................................... 90

6.6.1 QC Display ........................................................................................................... 92
6.6.2 Exporting QC Data .............................................................................................. 93
6.6.3 Viewing and Comparing Control Results .......................................................... 96
6.6.4 Manage and Define New Controls .................................................................... 100
6.6.5 QC Diary ............................................................................................................. 103
6.7 Entering Results.............................................................................. 105

6.7.1 IFA results using NOVA View ........................................................................... 105
6.7.2 Manual IFA results ............................................................................................ 111
6.7.3 Confirming results ............................................................................................ 121
6.8 Order screen .................................................................................... 127

6.8.1 Order status ....................................................................................................... 129
6.9 Patient screen.................................................................................. 138
6.10 Adding tests and profiles ............................................................... 140
6.11 Atlas ................................................................................................. 142
6.12 Statistics .......................................................................................... 145
6.13 MyFiles ............................................................................................. 148
6.14 Advanced Container Search .......................................................... 150

CHAPTER 7: Operational Precautions and Limitations ....... 152
7.1 Operational Precautions and Limitations ..................................... 152
CHAPTER 8: Potential Hazards ............................................... 153
8.1 Potential Hazards ............................................................................ 153
CHAPTER 9: Service and Maintenance ................................. 154
Intended Use CH. 1
CHAPTER 1: Intended Use

1.1 Intended Use
The QUANTA Link® Operators Manual is intended to describe the operation of the QUANTA Link software
program and to aid in the training of and to provide a reference for the software operator(s).
QUANTA Link is intended to control and process data exchanged between the QUANTA-Lyser®, NOVA
View®, DS2, DSX, NOVA Dot software, ACL AcuStar®, BIO-FLASH®, and Aptiva™ instruments in the
clinical autoimmune laboratory and the laboratory information system (LIS).
1.2 Product description
QUANTA Link® (hereafter “QUANTA Link”) is a centralized, intelligent software network system. This
program consists of two software programs and computer hardware to house the data and operate the
software programs. The program operates on a touch screen monitor.
1.3 Software description

QUANTA Link architecture is based on the Java 2 Enterprise Edition (J2EE) three layers architecture.
The Rich Client concept is used for the user interface and data determination is performed using a
Relational Database Management System.
Interaction with data between each layer is accomplished using:
1 XML over HTTP or HTTPs (secure HTTP) for communication between client and server.
2 JDBC to access the data in the database server.
This solution is independent from the hardware platform, is highly scalable and can be run on several
computers and operating systems.
To install and run this application, the following software must be resident on one reachable server
computer:
• Oracle 12c (recommended version 12.2.0.1)

• QUANTA Link application server version 4.0.02
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QUANTA Link 4.1 Operators Manual Rev. 0
1.4 Hardware description
The computer hardware required to operate QUANTA Link is dependent on the number of requests (tests)
processed per day and the number of images stored per request.
All installations require, at minimum, one Database Server, one Application Server and one Client
application.
Minimum hardware requirements are:
CLIENT
0 TO 250 251 TO 1,000 >1,000
SPECIFICATIONS
TOUCH SCREEN
(MINIMUM VERTICAL
19” 19” 19”
RESOLUTION: 1024
PIXELS)
PROCESSOR INTEL CORE I5 OR SIMILAR INTEL CORE I5 OR SIMILAR INTEL CORE I5 OR SIMILAR
RAM MINIMUM 4 GB 4 GB 4 GB
HARD DRIVE MINIMUM 500 GB 500 GB 500 GB
USB PORTS MINIMUM 3 3 3
NETWORK INTERFACE 1,000BASE-T/GIGAETHERNET 1,000BASE-T/GIGAETHERNET 1,000BASE-T/GIGAETHERNET
KEYBOARD & MOUSE REQUIRED REQUIRED REQUIRED

WIN 7, 8.1 OR 10 WIN 7, 8.1 OR 10 WIN 7, 8.1 OR 10
OPERATING SYSTEM
PROFESSIONAL 32 OR 64 BITS PROFESSIONAL 32 OR 64 BITS PROFESSIONAL 32 OR 64 BITS
SERVER SPECIFICATIONS 0 TO 250 251 TO 1,000 >1,000

1 INTEL CORE I7 OR 1 INTEL CORE I7 OR
PROCESSOR 1 INTEL CORE I7
1 INTEL XEON 5500 SERIES 1 INTEL XEON 5500 SERIES
RAM MINIMUM 8 GB 8 GB 16 GB
HARD DRIVE MINIMUM 500 GB 3 X 200 GB 3 X 300 GB
NETWORK INTERFACE 100/1,000BASE-T 100/1,000BASE-T 100/1,000BASE-T
WINDOWS 7, 8.1 OR 10 OR WINDOWS 7, 8.1 OR 10 OR

WINDOWS 7, 8.1 OR 10
OPERATING SYSTEM WINDOWS SERVER 2008 R2, WINDOWS SERVER 2008 R2,
PROFESSIONAL 32 OR 64 BITS
2012 R2, 2016 2012 R2, 2016
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Pre-installation CH. 2
CHAPTER 2: Pre-installation
2.1 Electrical requirements
Review hardware configuration manual to determine electrical requirements.
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Principles of Operation CH. 3
CHAPTER 3: Principles of Operation
3.1 Configuration
The following scheme summarizes the software configuration:
All information is stored in the Database Server.

1 Only the Application Server connects with the Database Server to save or transfer information
(encrypted communication)
2 All work stations are connected to the Application Server.
3 QUANTA Link work stations connect to the Application Server on one end, and to any external
system on the other (LIS, QUANTA-Lyser and NOVA View)
QUANTA Link can be connected to other systems (Host computers or instruments) using a client software
named ‘MultiOnline’.
Current connections include:

• ASTM LIS connection
• HL7 LIS connection
• QUANTA-Lyser
• NOVA View
• BIO-FLASH
• ACL AcuStar
• DS2/DSX
• NOVA Dot software
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• Aptiva
Drivers for instruments not listed above can be evaluated upon request.
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Performance Characteristics and Specifications CH. 4
CHAPTER 4: Performance Characteristics and Specifications
4.1 Electrical power
Refer to the operator manual of the computer where the software is installed.
4.2 Electrical requirements
4.3 Power consumption
4.4 Instrument noise
4.5 Physical Specifications
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Overview of User Interface CH. 5
CHAPTER 5: Overview of User Interface
5.1 QUANTA Link log-in
User identification is required to enter the program. Login information is captured on reports and required
to confirm the results.
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5.2 QUANTA Link functional areas
QUANTA Link is divided into reagent and reference areas that are accessible using navigation buttons.
These buttons are located on a ribbon that appears on the top right of most screens. Reagent areas are
separated by test type such as indirect immunofluorescence assay (IFA), enzyme-linked immunosorbent
assay (EIA) and chemiluminescent assay (CIA). Reference areas include support areas such as
dashboard and atlas
• Dashboard: A summary of all test methods from all instruments linked to the system.
• IFA: A summary of IFA tests from IFA instruments linked to the system
• EIA: A summary of EIA tests from EIA instruments linked to the system
• CIA: A summary of CIA instruments linked to the system
• Connections: A summary of instruments connected to the system
• Orders: Order lists with a powerful filter
• Sample Bank: A way to organize stored samples
• QC: A management module for quality controls
• Atlas: A summary of IFA images archived by the user
Operational instructions describing each area are found in Chapter 6, Operating Instructions.
The home screen displays navigation buttons in the upper left corner. Buttons for actions such as User
information, Settings, Statistics, Search, Container Search and MyFiles are located on the top left of
the screen. Buttons for Exit and Minimize are located at the top right of the screen.
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Most elements on screen can be activated by touch or mouse click. The behavior of each item may differ
in each screen.
2 3 4
In the example above, clicking a button would:
Item Action
1 Open a list of orders with test ANCA Ethanol, IFA pending
2 Open a list of orders with test Anti-Nuclear antibody, IFA with status ‘In process’
3 Open a list of orders with test Anti-Nuclear antibody, IFA with status ‘Result without approval’
4 Open a list of orders with test Anti-Nuclear antibody, IFA with status ‘Confirmed’
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5.2.1 Color codes and icons
A color code is used to identify test status. This color code is consistent throughout the application. The
following tables summarize the most common status color:
Test status color scheme:
Result
Technologist
Pending In process without Review Confirmed Sent
reviewed
approval
Dilution color code:
Requested, not Processed, without

Available, not requested With result
processed result
Test status icons:
Technologist
Pending With result Confirmed Review Sent blocked
reviewed
Order status icons:
Closed Open
Sample bank status icons:
Present with pending

Empty Present, all tests completed Taken out Selected
tests
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5.3 QUANTA Link dashboard reference area
The dashboard is the default screen and starting point after log-in. The dashboard is configured into four
graphs to organize workflow and determine the current test status at any time.
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5.4 IFA reagent area
IFA reagent area screen summarizes the list of current IFA tests received from the LIS and pending
orders. The list of available tests ordered is displayed alphabetically for each test. A test status bar
accompanies each test order to display the total number of samples and their respective test status.
Operator actions that can be initiated are:

LEGEND: Display color legend used in the application at the bottom of
the screen. To remove the legend, click the button again
SESSIONS: Open IFA session management tool to display slides in the

last IFA session
FILTER: Select date of the oldest order to be displayed
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5.5 EIA reagent area
EIA reagent area screen summarizes the list of current EIA tests received from the LIS and pending
Operator actions available in the EIA area include:
WORKLISTS: View and manage existing EIA work lists and create new ones
TESTS: Function management using tests
LEGEND: Display color legend used in the application. The legend will be
displayed until this button is clicked again.
RULES: Open batch validation options screen. To see more details about
this option go to section 6.6.3.1
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5.6 CIA reagent area
CIA reagent area screen summarizes the list of current CIA tests received from the LIS and pending
Operator actions available in the CIA area include:

WORK LISTS: View and manage existing CIA work lists and create new
ones:
LEGEND: Display color legend used in the application. The legend will be
displayed until this button is clicked again.
RULES: Open batch validation options screen. To see more details about
this option go to section 6.6.3.1
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5.7 Connections Screen
The Connections screen displays a list of instruments connected to QUANTA Link. Once an
instrument is selected, the user can view communication logs as well as any test results from that
instrument:
Additionally, a user can use the Connections screen to view or set-up QC controls for the selected
instrument, though this can also be done through the QC Management Area:
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5.8 Orders
The Orders screen displays a list of orders filtered by user criteria.
Operator actions available in the Orders screen include:
FILTER: Select criteria to list orders
PRINT: Print a report with the orders selected
RESEND: Send selected orders to the LIS.
The filter options are listed below:
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Date from Select initial date to filter orders. Clicking the date icon opens a calendar to
enter the date:
Date to Select final date to filter orders

Order from Select initial order number to select a range of orders
Order to Select final order number to select a range of orders
Tests Select tests to be included in the filter. Multiple tests can be selected
simultaneously.
Click arrow tip to open the drop down menu displaying available tests:
Test status Click and select test status to be used in the filter. Multiple test statuses
can be selected simultaneously:
In the example above both Results without approval and Confirmed have
been selected.
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The filtered orders can be printed. Click Print to open the options and create the report:
Click Submit to see the report:
The report header displays the options used to filter the orders. Included columns are:
Date and Number Order number and date when it was received in QUANTA Link
Service Hospital service placing the order
Name Patient full name, displayed as SURNAME, NAME
A. Patient age in years
G. Patient gender
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The filtered list of orders can be resent to the LIS. This feature can be used when the LIS connection is
lost and some results have not been received by the host, or during the installation process, to test the
interface with the LIS.
To use this feature click Resend and the option menu is displayed:
The options are listed below:

Action Select the type of action to send results to the LIS:
Test validation is commonly used to send results to the LIS

Host If more than one connection has been configured, select it from the list:
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5.9 Sample bank
Sample bank is used to organize and locate samples stored in the laboratory.
Operator actions available in the Requests screen include:

SAMPLE BANK SELECTOR: Select the sample
bank to store/retrieve samples
RACK SELECTOR: Select the rack in the sample
bank
ZOOM : Change the zoom level of the rack on
screen
ADD CONTAINER: Enter a container ID to add it
to the sample bank
SEARCH: Scan or type a sample tube to
store/retrieve it
PRINT: Print a report with the tubes in the

selected sample bank/rack
TAKE OUT: Mark a container as removed from

the sample bank
PUT BACK: Mark a sample as returned to the
sample bank
EMPTY POS: Empty a position in the sample
bank
ASSIGN: Add containers to the sample bank
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EMPTY: Empty one box or an entire sample
bank
The key to the icons is listed below:
Present with pending

Empty Present, all tests completed Taken out Selected
tests
The number at the bottom of the icon is the barcode of the sample stored in that position.
Clicking a rack position displays detailed information about the sample stored in that position:
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When a rack position is selected, available user actions are:
ORDER Navigates to the Order screen

ACTIONS LOG Display the latest actions for the container
LOCATIONS Display location of container in the sample bank
To search samples in the sample bank, scan the sample barcode in the Container text box:
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If the sample already exists in the sample bank, the details are displayed.
Clicking on the location will highlight the container position in the sample bank
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To add one sample to the sample bank, select one empty position:
Select Add Container, to store the sample in the selected position:
Scan or type the sample barcode to save the sample in the sample bank.
A batch of samples can be stored using the option Assign.

A filter is presented to select the batch of tubes to be stored in the sample bank:
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5.10 QC Management Area
The QC screen provides the user with the tools to manage and review QC data across every
instrument connected to QUANTA Link.
For additional information on how to manage controls or access graphical data and statistics,
reference the QC Overview section.
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5.11 Atlas reference area
The Atlas screen contains the images stored for use inside or outside the application. These
images are not linked to patient information.
Operator actions available in the Atlas include:
ATTACHMENT: Open the file browser to add any image in the local
hard drive or network drive in the current Atlas.
MICRO: Open the screen to manage and capture images from a

compatible camera connected to the system.
PASTE: Paste an image copied in the computer clipboard into the

Atlas.
EXPORT: Export filtered selection to a zip file that can be imported

into another QUANTA Link atlas
IMPORT: Import existing QUANTA Link atlas export
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5.12 Common operator actions
Four buttons common to all screens in the application are: User Information, Settings, Search,
Statistics and Exit.
5.12.1 User Information
User information is used to view the user currently logged into the application, change the
user’s password and view the QUANTA Link serial number. If the password for this user expires
within the next 30 days, a warning will appear in this screen and the user can select the prompt to
change their password.
5.12.2 Settings
Settings is used to setup common programs.
Default printers and Sample Bank date considerations are setup in Setup Label Printer.
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Microscope cameras are setup in Setup Microscope.
Dictionary is used for defining shortcuts to be used for comments. Once the codes have been set
up, the user only needs to enter the code and use the Shift+Enter keys to have the translation
appear in the comment box.
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5.12.3 Search
The Search icon is a unified tool to quickly locate patient, requests and slides within the system.
The search field is used to search for patients, by name, surname, name+surname, patient ID or ICU ID,
orders by order number or slides by slide number. Wildcards such as _ and % can be used to assist the
user in the search. Search help can be found by selecting the information button . Search results can
be selected using the up and down arrows on the keyboard. Up to 500 patients for a search will be
displayed in the result list.
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5.12.4 Statistics
If Statistics have been enabled, an icon ( ) will appear. Clicking this icon will open the Statistics
module
See Section 6.12 for additional details
5.12.5 Minimize
The minimize icon is used to minimize the QUANTA Link application
5.12.6 Exit
The Exit icon is used to log out or close the application.
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Operating Instructions CH. 6
CHAPTER 6: Operating Instructions

6.1 Logging in
1 To log into the software program, double click the QUANTA Link software icon and enter a user
identification and password. User identification is required to open the program. Login information is
printed on reports and is required to confirm results.
QUANTA Link application icon
2 After the IP address has been successfully connected the value will be stored and there is no
need to re-enter the IP address.
3 After login, the software is standing by for use.
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6.2 Navigation buttons
Navigation buttons are located at the right side of the ribbon. These are used to access different reagent
and reference areas: Dashboard, IFA, EIA, CIA, Orders, Connections, QC, Sample Bank, and Atlas.
When a button is selected, it becomes highlighted and changes to a dark background with a white
arrowhead at the bottom of the button.
Dashboard area selected
Navigation buttons are present on most application screens.
6.3 Dashboard functional area

6.3.1 Status by reagent
The dashboard displays the current number of tests organized by test status for each reagent area. An
extra bar lists all tests older than 24 hours.
Available reagent areas include: IFA, EIA and CIA. Available test status options are: Pending, In
process, Results and Confirmed.
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6.3.2 Status summary
This graph displays the total number of tests by test status for each reagent area. An extra bar displays
all tests older than 24 hours. Available reagents are: IFA, EIA, and CIA.
6.3.3 Test status
This graph displays the number of samples in each reagent area for the selected test. An extra bar
displays all tests older than 24 hours.
Click Options to select a test. Select a test from the pull-down menu to see the details on the
graph.
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6.3.4 Positive results
This graph displays the number of positive results by reagent area.
Time can be selected by clicking the Options icon, . Select the days to review details on the graph.
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6.4 IFA Section
6.4.1 IFA pending list
To view the list of orders having a selected test pending:
Click any of the test buttons in the

list to open a screen with a list of
orders having the selected test
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This screen allows the operator to modify dilutions for a sample while reviewing the latest previous result.
Therefore, a worklist can be easily prepared before loading the samples into QUANTA-Lyser.
Previous result displayed here
Test order number
Dilution available to be
processed
Click any dilution with a black background (available) it will turn gray (requested).
If the sample is marked as Load, the button with the test name displays the number of dilutions selected,
to determine the number of slides required to process the worklist.
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Click the test order number to view the complete order of all tests requested:
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6.4.2 IFA status list
Click the status bar in the list to open a screen with a list of orders with the selected test in the selected
status:
The Order button opens the test order to review results and patient information.
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6.4.3 IFA Legend
Click Legend button to view the color code legend on the screen.
The legend will be displayed until the Legend button is clicked again.
The color indicators include the number of orders in that status and can be clicked to see a list of orders.
The list includes all tests in the selected status for the reagent area:
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6.4.4 Order filter
Click the Filter button to select the date of the older order to be displayed:
Check the box and select the number of days for the older order to be displayed for this section:
All status bars for the current section will be filtered:
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The filter will remain active when clicking one of the status bars:
Date filter applied
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6.4.5 IFA Sessions
Sessions opens a screen that summarizes the most recent IFA worklist processed. All slides in the
worklist are identified by slide type and barcode (if available). This information can be modified as
required.
Each well has a badge displaying its status following the same code as tests:
Technologist
Pending With result Confirmed Review Sent Repeat
reviewed
Quality control
Technical validation
Review
Sent
Validated
Results without approval

Repeated dilution
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Available operator actions in the IFA sessions include:
PENDING: Create a report of all IFA pending samples.
REVIEW: Review images and confirm results received from NOVA View.
RESULTS: Assign results to IFA sessions processed through QUANTA-Lyser.
BACK: Close the IFA session screen and return to the IFA section screen.
NEW: Create a new IFA session manually
EDIT: Edit IFA Session name
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6.4.5.1 Working with IFA Sessions
The button with the session name in it opens the list of available IFA sessions for review.
Available operator actions in the IFA session list include:
SESSION NAME: Select the current session to review
CLOSE: If all tests and dilutions in the session are in a final status,
close the selected session.
OPEN: Open a closed IFA session. Closed IFA sessions have the
session name button with a red background:
DELETE: Erase the selected session.
BACK: Close the popup menu and return to the IFA session
screen.
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6.4.5.2 Review
If QUANTA Link is connected to NOVA View, click Review to open a screen with a matrix of images
received from the instrument from the current worklist. The images can be sorted using the Nuclear
Intensity value, lower to higher, position on the slide or by patient:
Available operator actions in this screen include:
RESULTS FILTER: Display Negative, Positive or All results
TEST FILTER: Filter the tests displayed when multiple tests have been
run in a session
SORT BY: Select how to sort images in the matrix: by position in the
IFA session, by Intensity or by Patient name.
RULES: Open the batch validation options screen. To see more details
about this option go to section 6.6.3.1
VALIDATE ALL: Confirm all results on the screen. If a filter is applied
(Negative or Positive), only the filtered results will be validated.
BACK: Close this screen and return to the IFA sessions screen.
FITC: Change the status of the FITC filter: if the FITC filter is on, click
this button to turn it off. The FITC layer is the green image.
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DAPI: Change the status of the DAPI filter: if the DAPI filter is on, click
this button to turn it off. The DAPI layer is the blue DNA stained image.
POSITIVE SECONDARY RESULT: Displays a red square around the 1st
letter of the secondary result that has been set up in the configuration.
NEGATIVE SECONDARY RESULT: Displays a black square around the 1st
letter of the secondary result that has been set up in the configuration.
6.4.5.3 Validation screen
Click on one of the images in the matrix to open a window that displays the full size of the image along
with all available information about the dilution:
Available actions in this screen include:

ZOOM SLIDER: Change the zoom level of the image using the sliding bar.
ZOOM: Click to use the 2x zoom magnifying glass.
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ADJUST: This function fits the image to the current screen size. It can also be
used to resize the image after a zoom to see the full image.
FITC: Change the status of the FITC filter: if the FITC filter is on, click this button
to turn it off. The FITC layer is the green image.
DAPI: Change the status of the DAPI filter: if the DAPI filter is on, click this button
to turn it off. The DAPI layer is blue DNA stained image.
Max. int.: Change the status of the Maximum Intensity filter: if it is on, click this
button to turn it off.
IMAGE OPTIONS: Image management options are:
• Copy to clipboard: copies current image into the clipboard

• Send to Atlas: copies the image to the selected Atlas. There is a
button for each Atlas defined in the application.
• Save: Saves the image to the hard drive.
NEXT: Move to the next well.
PREVIOUS: Move to the previous well.
DELETE IMAGE: Erase the selected image from the patient record.
ATTACH: Select any image from your hard drive and add it to the patient
record.
PASTE: Copy the image in the clipboard into the patient record.
COMPARE: Open Multi-Analyte/Compare screen
TEST STATUS: Modify the test status. Available options includes:

WITHOUT VALIDATION STATUS: the test has a non-confirmed
result
TECH REVIEWED: a technologist has reviewed the result.
CONFIRMED: final result confirmed and sent to the LIS.
REVIEW: the result needs further review before confirming
SENT BLOCKED: final result. This result is not sent to the LIS
REJECT TEST: cancel the test.
Test Result: Select the test result from the list of coded values configured
for this assay.
DILUTION RESULT: Select the dilution result from the list of coded values
configured for this assay.
PATTERN: Select the pattern from the list configured for this assay.
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SECONDARY RESULT: Select the result for the secondary dilution result, in this
case, Cytoplasmic, from the list of coded values configured for this result
COMMENTS: Review or modify comments for the patient, the test and any
dilution for this sample. The icon changes depending on the comments
available. Any combination of the following options is valid:
No comments
Patient comment
Test comment
Current dilution comment
Different from current dilution comment

EXPORT: Print an IFA test report for the current sample including up to four
images.
Generate PDF report of dilution results,
images and location that can be saved or
printed
Generate zip file including images from
current and previous dilutions (if available
and option selected) that can be saved
ADD: Add any test in the QUANTA Link menu to the current sample.
HISTORY: Review previous results of the patient. Depending on the results

available, the button color changes:
No previous results available for this sample
Previous results for any test other than the current one
Previous results for the current test within the validity

period of the test
REPEAT: Repeat the current dilution next time the sample is loaded in the IFA
processor.
DILUTIONS: Add new dilutions to the current sample.
Additional dilutions have been requested for this sample
Additional dilutions have been processed in the same

session as the dilution being viewed
VALIDATE: Confirm the test result and send it to the LIS.
AUTOTITER: Only available if the slide was scanned on the NOVA View. See
NOVA View Operator’s Manual for complete description of Autotiter/Single
Well Titer.
COMPARE: Opens the Multi-Analyte screen, displaying a mosaic of images
from current test, Atlas, repeated dilutions and other tests for the same
patient.
UNDO: Clear all modifications made to the test.
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BACK: Saves all changes and returns to the IFA session image matrix.
6.4.5.4 Repeated dilutions
If a dilution has been selected to be repeated, the images associated with the selected dilution will be
available in the session in which it was run. No modifications can be made to the results that have been
designated for repetition. The dilution results shown belong to the repetition in the session however the
test result reflects the most current result, which does not take the dilution selected for repetition into
account.
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6.4.5.5 Multi-Analyte/Compare screen
This screen displays images from different tests and/or dilutions, as well as the Atlas. The configuration
is saved per test, so different methods can have different setups. To configure the screen layout and the
source for images on the tiles, click Setup:
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The button with the plus sign adds a row to the screen layout:
A new button appears when a row is added.
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The new button at the top right of the screen adds a column to the current row:
Any combination of rows and columns is allowed.
3x3 2+4
When the layout for the current method is finished, image sources can be selected:
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Available image sources are:
• Images from other tests in the same request
• Images from current dilution
• Images from patient history
• Images from Atlas
• Images from other repetitions
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If option Images from Atlas is selected, options are:
• Atlas where images are saved
• Keywords to filter images in the Atlas
If Images from other tests in the same request is selected, following options are available:
• Test
• Dilution
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Clicking on Test opens a list of available IFA tests to select the desired method to be compared with the
current one (including the same method):
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Clicking on Dilution opens a list with the dilutions configured for the selected method plus:
• Same dilution as current dilution: the system will use the dilution of the selected well. Take into
account that some methods may have different dilution ratios configured and selecting this option
can result in getting no images to display.
• Proportional dilution in test: as different tests can have different dilution ratios, this option uses the
equivalent dilution on both tests, i.e. if current well is 1/80 and the screening dilution for that
method is 1/80, the system will use the screening dilution for the selected method. If current well is
1/320 (the 3rd dilution if 1/80 is the screening one), the system will use the 3rd dilution configured
for the compared method.
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If Images from patient history is selected, available options are:
• Test
• Dilution
Clicking on Test opens a list of available IFA tests to select the desired method to be compared with the
current one (including the same method):
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Clicking on Dilution opens a list with the dilutions configured for the selected method plus:
• Same dilution as current dilution: the system will use the dilution of the selected well. Take into
account that some methods may have different dilution ratios configured and selecting this option
can result in getting no images to display.
• Proportional dilution in test: as different tests can have different dilution ratios, this option uses the
equivalent dilution on both tests, i.e. if current well is 1/80 and the screening dilution for that
method is 1/80, the system will use the screening dilution for the selected method. If current well is
1/320 (the 3rd dilution if 1/80 is the screening one), the system will use the 3rd dilution configured
for the compared method.
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Selecting Images from other repetitions will display images from the previous dilution repetition.
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When screen layout is finished, click Back and changes will be saved and the new layout will be
populated with images from the selected sources (if available):
DAPI/FITC filters are available and apply to all images on screen. Each image has local options like:
• Zoom level: slide to select the image zoom
• Zoom (magnifying glass): 2x zoom lens magnifies the image below while dragged
• Adjust: changes the image size to fit the panel
• Max. Int.: If available, maximum intensity image is displayed when selecting this option
• Mitotic cells strip: available images from mitotic cells are displayed here.
• Image thumbnails: other available images for the selected tile are displayed here. Scroll down to
see all available images.
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The following is the same screen with the DAPI filter deactivated:
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Click on one of the images in the array to open a window that displays the full size image:
Image specific functions are still available in this screen:

• Zoom level
• Zoom (magnifying glass)
• Adjust
• FITC/DAPI filters
• Image options menu
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6.4.5.6 Dark Room (Manual microscope function)
Dark Room can be accessed from the IFA Session screen by selecting Dark Room.
This screen is intended to allow the operator to enter results from a manual microscope to any dilution on
a slide.
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Available operator actions in this screen include:
SEARCH SLIDE. Click this button to open a text entry field to search slides in the
current session using the slide ID:
Enter the slide ID and click enter or scan the slide barcode to search a slide in
the current session:
If the slide is found, the application will display it and allow the user to enter data.
If no slide with such barcode is found, a fading message is displayed.
COMMENTS: Review or modify patient comments for the test and any dilution for
this sample. The icon changes depending on the comments available. Any
combination of the following options are valid:
No comments
Patient comment
Test comment
Current dilution comment
Different from current dilution comment
SLIDE SELECTOR: This function is used to size the image to the current screen
dimension. It can also be used to resize the image after a zoom to see the full
image.
PREVIOUS: Move to the previous well
NEXT: Move to the next well
ADD: Add any test in the QUANTA Link menu to the current sample.
HISTORY: Review previous results of the patient. Depending on the

results available, the button color changes:
No previous results available for this sample
Previous results for any test other than the current one
Previous results for the current test within the validity

period of the test
REPEAT: Repeat the current dilution next time the sample is loaded in the IFA
processor.
NEGATIVE: Assign a negative result to all dilutions for the same sample and to all
tests of the same sample.
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DILUTIONS: Add new dilutions to the current sample.
Additional dilutions have been requested for this sample
Additional dilutions for the same sample have been

processed in the same session
COMPARE: Opens the Multi-Analyte screen, displaying a mosaic of images from
current test, ATLAS and other tests for the same patient.
CAPTURE IMAGE: Capture one image using the microscope configured in the
application. A popup window displays the live image in the microscope with
adjustable parameters. These parameters are different for each camera model.
UNDO: Clear all modifications made to the test. Undo button will be disabled if no
changes have been made to the current dilution:
BACK: Close the screen and return to the IFA session screen.
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The slide displays the status of each well with the following color code:
Status/Content With Sample Related to another well
Pending
Selected
Empty
The patient order can be accessed by selecting the order number. Results in the order screen
cannot be modified when being accessed from the dark room
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6.4.5.7 Pending report
If a sample contains additional dilutions or reflex tests that have not been completed, this report is used
to summarize them. This report can also be used to view results entered for each dilution, including IFA
Reader results
The options used to filter this report include:

ALL TESTS: All tests for each sample are included,
even if they already have a result
PENDING TESTS: Only tests with no result or with
SHOW dilutions pending
SESSION TESTS: Only tests present in the current
This is a sample report: session, not considering other tests that may not
have been run yet.
SELECT NONE: Show no IFA Reader results on report
THE IFA IFA READERS: Show selected IFA Reader results
READER on report
SORT BY REQUEST AND SAMPLE: Report organized
by order number.
SORT SORT BY REQUEST DATE: Report organized by
order request date.
SORT BY SESSION LOCATION: Report organized by
sample position on the wells and slides.
CIA: Chemiluminiscence Immuno Assay
SECTIONS
EIA: Enzyme Immuno Assay
IFA: Immunofluorescence Assay
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Available operator actions for the report include:
PREVIOUS: See previous page
NEXT: See next page
FIT PAGE: View an entire page on screen
FIT WIDTH: Make the page fill the width of the screen
PRINT: Print the file
SAVE: Save the report as a PDF file
CANCEL: Close the report
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6.4.6 Connections
This screen displays the instrument related information.
Each instrument connected to QUANTA Link appears in the drop-down menu as a separate selection,
including connections to the LIS.
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Available operator actions include:
REPORT: Create QC associated with a connection
REPORT: Create report for specific control and date range
LOG: Display the action log of the instrument communication
LOAD: Load individual samples into the selected instrument, and select the tests to be
loaded for all samples. Following options are available:
Delete all samples in the load list
Select tests to be loaded into the instrument
Select samples to be loaded into the instrument
RESULTS: Display latest results received from the selected instrument. Available options
are:
Select tests to load into the instrument
Undo unsaved changes
Save changes
R. CONTROL: Remote control enables remote access to the selected instrument. It

requires a VNC compatible software installed in the instrument.
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6.4.7 IFA workflow
QUANTA Link allows the IFA workflow to be configured by the method of sample loading and by the type
and number of instruments connected to the system.
6.4.7.1 Automatic load
Using host query compatible instruments, (QUANTA-Lyser, BIO-FLASH etc.), it is possible to load test
information by scanning sample barcodes.
The instrument queries QUANTA Link for test information about the scanned samples, and QUANTA
Link supplies the list of pending tests for each sample. This entire process is automated and no user
action is required. The same method can be used for IFA, EIA or CIA instruments.
To select specific tests to send to the instrument go to Connections, select the instrument to load, select
the Load option, and click the Tests button:
This opens a pop-up a window where each test can be marked as loadable. Only test information for
tests marked as load will be uploaded to the instrument. Information for tests not marked as load, will not
be sent to the instrument.
The selection is saved until it is changed.
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6.4.7.2 Manual load (IFA)
To manually load an IFA run, go to IFA and click the test name to be processed in the next session:
This opens a window with a list of all orders having the selected test pending.
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The selected test appears on top of the list of tests to the left of the screen.
The following information is displayed for each order:
Order number
Patient age
Patient name Patient gender
Last previous result
Dilution list ‘Load’ selector

Test code
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Each request contains basic patient information, detailed test and dilution information.
Dilutions follow a color code to identify the status:
Color
Available, not Requested, not Processed, without
Status With result
requested processed result
Each sample to be sent can be selected individually. Click Load to the right of one sample to select it.
To select all tests and dilutions on the list, click All at the bottom of the screen. The system will count the
number of dilutions selected and the total amount will be displayed by the test name in the selection
button.
The number can be used as a guide to calculate the number of slides required to run the whole session,
and select or deselect some dilutions accordingly.
Once samples have been selected, click Export and a list of available instrument opens:
Select the instrument to load and the work list is sent to the instrument. The application will inform the
user the number of samples sent.
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6.5 EIA/CIA/Aptiva Sections
EIA, CIA, and Aptiva sections use the same layout:
The operator can decide to work with work lists (if the instruments support this feature) or with individual
tests.
Available operator actions include:
WORKLISTS: Manage the worklists defined in the application for the

current function (EIA/CIA).
LEGEND: Display the color legend used in the application. The legend
will be displayed until this button is clicked again.
RESULTS: Display the results for tests in the worklists.
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6.5.1 Worklists
When the worklists mode is selected, buttons to the left of the screen refer to the number of worklists
defined in the software configuration. The number adjacent to the name indicates the number of samples
that meet the conditions that will be included in a new worklist.
The tests in each worklist are displayed to the right of each worklist button.
In the example above, worklist ENA Panel includes the tests with codes SSA, SSB, SM, RNP, SCL70
and JO1. The ‘0’ in parenthesis indicates that there are no pending samples to create a new worklist of
this type.
Click one of the worklist buttons with any pending sample to create a new worklist.
QUANTA Link displays a message with the number of samples included in the new worklist:
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Use the Results button to navigate to this screen to view results for the selected worklist.
The first column on the left indicates the request ID. Other columns represent the tests included in the
worklist. This format allows multiple results to be reviewed at the same time for an individual sample.
Click the name of the test to open a menu with the following options affecting all samples in the worklist:
RERUN TEST: Clear the result for the current test
UNDO VALIDATION: Clear the validation status
VALIDATE: Confirm results and send them to the LIS
INVALIDATE: Mark all results for revision
CANCEL: Close the menu
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The button at the top of the worklist panel allows the operator to select any of the existing worklists:
This number is automatically assigned by QUANTA Link when a new worklist is created.
Click this button to open a list with all available worklists.
Each row represents a worklist, identified by the number and worklist type name.
Available operator actions for each list are:
CLOSE: If all tests are in a final status (validated or sent), close the
worklist. A closed worklist cannot be modified unless reopened.
DELETE: Clear the selected worklist. Tests and samples in the worklist
are not deleted.
OPEN: Click the name of the worklist to open it
The status bar displays the number of samples in each status following the application color code.
In this example, test status includes:

confirmed; review pending and confirm a
pending result.
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6.5.2 Tests
When test mode is selected, the buttons to the left of the screen refer to the available tests, and status of
each one is displayed with the colored bars.
Click the test name to open a screen with the list of orders having this test, and the result and status for
the selected test:
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Click the order number button to open the request screen with all tests and results for the selected
sample. Results and status can be modified and the test can be marked for repeat from this screen.
Click the down arrow to the right of the test code to open a menu with the following options affecting all
samples in the list:
RERUN TEST: Clear the result for the current test
UNDO VALIDATION: Clear the validation status
VALIDATE: Confirm results and send them to the LIS
INVALIDATE: Mark all results for revision
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6.5.3 EIA/CIA/Aptiva workflow
6.5.3.1 Instrument loading
With host query compatible instruments, (QUANTA-Lyser, BIO-FLASH, Aptiva), it is possible to load
primary samples by scanning sample barcodes directly using the internal scanner in the instrument.
The instrument queries QUANTA Link to upload information about the scanned samples, and QUANTA
Link supplies the list of pending tests for each sample. This entire process is automated requiring no
user interaction after loading samples in the instrument. This method is valid for IFA, EIA or CIA
instruments.
To select tests to send to the instrument go to Connections, select the instrument to be loaded, select
the Load option, and click the Tests button.
This opens a pop-up window where each test can be marked as loadable. Only tests marked as load will
be uploaded to the instrument. Tests not marked as load, will not be sent to the instrument.
The selection is saved until it is changed.
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6.6 QC Overview
QC can now be accessed through the top ribbon within QUANTA Link
When the QC button is selected, a popup displaying all configured connections will be displayed.
Select the connection to view the related QC information and results
Possible statuses of connections are:

All QC is within the desired criteria
One or more QC point is at least 1 SD outside of the mean, but within
flags
One or more QC point is outside of the defined flags
No QC data is available
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Once an instrument is selected, an overview of QC status for all configured tests for that
connection are displayed
The user is given additional controls at the bottom of the screen with the following actions:
Instrument: allows the user to select an instrument to view its QC
Graphs: displays the Levey-Jennings plots for the current selected QC
Setup: configures QC material for the selected instrument
Add: allows the user to add QC material to the current selected

instrument
Results: Displays a list of results and associated statistics organized by
control
Export: prompts the user to export control data for a specified date
range a selected format
QC Export: prompts the user to export control data for a specified date
range in the .XLS format
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Compare: allows the user to create, select, and display a comparison
two or more controls across one or more instruments
Diary: displays the log activity for a given day for all controls
Options: displays additional options to allow a user to configure QC
6.6.1 QC Display
Graphs for all controls for a given instrument are available by pressing the Graphs button from the
main QC screen. Within the graphs interface, the user can select controls to view via the ‘Selector’
menu on the left side of the screen, or view the control data via the ‘Details’ view at the bottom of
the screen.
The QC graph display screen can be customized using the options on the tools under the graph:
Single: Toggle display of controls on a single or combined graphs
Details: Toggle display of control data tables below graphs
Selector: Toggle display of control test selection on the left side of the
screen
Add: allows the user to add a control point for any test in the selected
instrument
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Report: allows the user to print the selected graphs or export them to
Excel
Delete: removes the last selected QC point
Calibration: allows the user to indicate a Validation of Calibration
6.6.2 Exporting QC Data

Exporting control data is available through Export and QC Export:
The Export option displays a prompt to export control data in the selected format for a specified
date range:
After entering a valid date range, selecting a type, and naming the exported file, a file explorer is
displayed for the user to select a file location on the computer:
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Alternatively, the user can use the QC Export button which displays a prompt to export control
data for a given date range in the Excel (.XLS) format:
After providing a file name, valid date range, section, instrument, and control type, the My Files
window within QUANTA Link is displayed so the user can view the report
*NOTE: the file name must include a “.XLS” file extension
While the file is being prepared to export, a summary window is displayed. It will display when the
file is ready to export. Select My Files to find the file:
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Under the Exports tab, a history of all QUANTA Link file exports is displayed. Select an export to
save this report to a location on the computer:
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6.6.3 Viewing and Comparing Control Results
A user can access the control comparison menu via the Compare button on the bottom of the QC
window:
A popup will display previously created comparison profiles, as well as the option to create a new
comparison profile. To create a profile, select Create:
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To create a comparison profile, the user must provide a description for the profile, and add two or
more controls from any instrument or test. The Submit button creates the new comparison profile:
To view the new comparison profile, the user can select it from the Comparison Profile screen:
Once in the comparison profile, the controls are visible on individual graphs or overlaid onto a
single graph when the Single button is selected:
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Additionally, control performance is visible via the Performance button at the bottom of the
screen, and reports can be generated in a PDF format by selecting the Report button:
Intelligent Quality Control is also available via the IQC button at the bottom of the screen. This
displays the comparison of the performance across all the controls in the comparison profile:
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6.6.4 Manage and Define New Controls
To manage existing control definitions or to add new ones, click the Setup button in the toolbar
below:
This displays a list of all the current defined mnemonics for controls for the selected instrument:
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*NOTE* for some instruments like BIO-FLASH, controls are separated by mnemonics and may
appear similar to the ones shown below:
To edit an existing mnemonic, click the row for that control:
Additional controls are available via the options button on the left :
After a mnemonic row is clicked, all controls sharing that mnemonic are displayed:
To add a test to an existing mnemonic, click the Add Test button to display the QC Test Definition
dialog. For all numeric based controls the following fields are required:
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For interpreted based controls, the dialog appears as follows:
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6.6.5 QC Diary
To view the control events for a given day, the user can select Diary from the bottom of the QC
screen:
The control activity will be displayed for the selected day, and can either by typed in or selected
via the calendar
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This will display the activity and values for any controls entered on that day:
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6.7 Entering Results
6.7.1 IFA results using NOVA View
After IFA slide processing is complete, the slides are transferred to NOVA View for analysis. To confirm
the results and patterns from NOVA View, select IFA section, go to IFA sessions, and select the
session to review from the list of IFA Sessions by clicking on the session name and click Review to
access the validation screen with images:
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The validation screen for IFA sessions has three main areas:
1
2
1. The primary section of the screen displays an expanded view of each selected image.
2. A list of thumbnail images available for review for each sample.
3. The bottom of the screen contains test and dilution results and pattern, as well as all the available
actions in the screen.
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To analyze an image, expand one image from the thumbnail list by touching or clicking it. The selected
image is displayed on the main screen. Double click on the image to zoom.
To enable a result (positive or negative) to the sample, click on the bar under the Test Result drop down
at the bottom of the screen. The positive and negative buttons are enabled.
The test result will change accordingly

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To enable the pattern options, click the pattern button.
Select the pattern from the list and click Submit to save changes. Up to 3 patterns can be selected for
each dilution.
Comments can be added to the test clicking the comments icon .
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Access to the Order screen for this request is available by selecting the order number. Results in the
order screen cannot be modified when being accessed from the NOVA View screen.
After the test result is finalized, press Validate to confirm the result. This action sends the test result to
the LIS (actions taken upon confirmation depend on the system configuration).
Navigate across the session using the Previous and Next buttons on top of the thumbnail list.
Click Back to save changes and go back to the image matrix screen to analyze the next sample.
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6.7.2 Manual IFA results
To review IFA slides using a microscope, go to the IFA function, select IFA sessions, and select the
session to review from the ‘IFA Sessions’ list. Click ‘Dark room to access the low contrast screen:
The slide type and identification are located below the slide picture. Click the slide type box to select one
of the available slides from the list. Edit the slide identification in the appropriate field.
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Information about the session and the selected slide is displayed above the slide. Slides are grouped,
and each one has a label matching the barcode of the slide or the information entered by the user. The
selected slide is depicted in the large area along with demographic information and the Comments
button.
Wells use the following color code:
Status/Content With Sample Related to another

well
Pending
Selected
Empty
The Search button, , on the top right provides a way to look up a slide using the ID or label. A slide
barcode number can also be used to find a specific slide in the current session. If the slide is found, the
application will select it and display its information on screen.
The central area of the screen is reserved for well information: The button (or buttons if more than one
test can be assigned can result from one well, i.e. KSL) shows the test code.
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Sample dilution ratio and previous results (if available) are displayed on the top left of this area.
Dilution result can be customized in the configuration. A button is presented for each possible dilution
result:
To assign a result to a dilution, select one of the available results (this list can be customized). If the
selected result is positive, a range of patterns will be displayed (depending on the system configuration,
the test could have no pattern family assigned, in this case, no patterns are displayed, even if the dilution
result is positive).
Up to three different patterns can be simultaneously selected for one positive dilution. To deselect one
pattern, simply click it again.
If dilution result is not positive, the application blocks the pattern buttons:
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To assign a secondary result, selct the button next to the secondary result name, in this case
“Cytoplasmic”
If there is any image on the patient’s record, it is shown in the area under the pattern.
This area also contains a button to capture images from a compatible camera connected to the system.
At the bottom of the screen, all action buttons can be found:
After entering the result for the current dilution, click Next to edit the following well:
Click Undo to cancel all modifications made.
Click Exit to close this window saving the modifications made.
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6.7.2.1 IFA Readers, Blind Validators and Validators
IFA Readers, Blind Validators and Validators are set up in QUANTA Link Configuration. Each user has
different permissions
Blind Validator
User function IFA Reader
Validator (normal user)
Enter IFA Reader results In Dark Room X
Enter IFA Reader results In NOVA View screen X
Enter final results In Dark Room X X
Enter final results In NOVA View screen X X
Review IFA Reader results X X
Review IFA Reader results blinded X
Enter comments X X X
View History X X X
Add images X X X
Access Compare screen X X X
Access Atlas X X X
Print IFA Session report X X X
Validate results X X
Run validation rules X X
Enter slide barcode information X X
Repeat slides X X
Repeat wells X X
Create new IFA Sessions X X
Add dilutions X X
Add tests X X
Review and validate non-IFA results X X X
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6.7.2.1.1 IFA Readers
Up to 2 IFA Readers per test can enter results that will later be reviewed by a Validator or Blind Validator
Results can be entered in the Dark Room or NOVA View screens and images can be captured and
attached to the dilution.
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6.7.2.1.2 Blind Validators
Blind Validators and Validators can see how many IFA readers have entered results for a slide by viewing
the icon next to the slide barcode, a silhouette of a user.
Blind Validators have an

Options button located on the bottom action ribbon
NOTE: Clicking the Options button displays 2 workflow options for a Blind Validator. The choice affects
the performance of the Next button in the Dark Room screen. When “Always see Reader results” is
checked, clicking the Next button in the Dark Room will display Reader results. When “See only
discrepant reader results” is checked, clicking the Next button will only display Reader results if they do
not match the Blind Validator’s results or another IFA Reader’s results. This feature applies to dilution
results, secondary results and patterns.
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Blind Validator results can be entered without the influence of any other IFA Readers
When Next is selected, IFA Reader results (or only discrepant results) will appear on screen, depending
on the option selected for the Blind Validator
NOTE: If there is no agreement on the secondary result, the reader badge will be displayed on the button
but the result chosen will not be displayed unless the Blind Validator clicks into the combo box.
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6.7.2.1.3 Validators
A Validator will see all IFA Reader results, whether or not they are discrepant
Once results have been entered by a Blind Validator or Validator, badges on the wells will change from a
gray, Pending badge to a purple, Results without Approval badge.
A report can be generated by selecting the Pending button
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6.7.2.2 Shortcut keys available
Dark Room and NOVA View screens

• Right arrow moves to next well or next test (if multiple tests are in 1 well)
• Left arrow moves to previous well or previous test (if multiple tests are in 1 well)
• Numbers select coded value
o 1 = first coded value on screen, 2 = second coded value on screen etc.
o If positive coded value selected, pressing a number will select pattern
o 1 = first pattern on screen, 2 = second pattern on screen, 3 = third pattern etc.
o 0 = clear dilution result (including pattern)
o Backspace will exit Dark Room and return to IFA Session
• ESC closes any open popup windows
• Del initiates deleting of an image and opens a popup warning the user that deleting images is
permanent
Atlas
• Right arrow moves to next image
• Left arrow moves to previous image
• Backspace will exit and return to Atlas matrix screen
• i will open Info window for an Atlas image
• ESC closes any open popup windows
Image screens
• Double clicking left mouse button on an image will zoom in to the location where the mouse is
being clicked
• Double clicking right mouse button on an image will zoom out
• Scrolling the mouse wheel forward while holding Ctrl on the keyboard will zoom in to the location
where the mouse hovering
• Scrolling the mouse wheel backward while holding Ctrl on the keyboard will zoom out
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6.7.3 Confirming results
6.7.3.1 Expert rules processing
In the dark room screen, results are manually assigned to all dilutions of a sample in an IFA session.
QUANTA Link can assign results to the test depending on the dilution results. When all dilutions in a
session have a result, the corresponding tests also have one.
One way to validate tests results and send them to the LIS is to click Rules in the IFA image matrix
screen:
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This launches the expert validation process:
Complete all the validation parameters below:
Orders without assigned

Confirmation takes into account orders with no patient if checked
patient
Orders without patient’s
Process tests of patients with no gender or age if checked
gender or age
Orders with results in all
Process orders only with results for all tests
Tests
Tests with Technically
Process tests with results that have a Tech Reviewed result status
Approved results
Process test validation. If left unchecked, rules will be run but results will
Default validation
not be validated.
Process validation rules Initiate rules defined in configuration to invalidate tests are processed
Process manipulation
Initiate rules configured to modify the order are processed if checked
rules
Category Specify a rule category to be processed
Invalidate abnormal If checked, all results flagged as Abnormal, that is, pathologic, are
results (*) marked as Review for later review
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Invalidate very abnormal Result flagged as very abnormal are marked as Review for later review
results (**) if checked
Reprocess tests with Confirmation process will run the rules and parameters above also for
validated results tests already confirmed
Reprocess tests with
Apply the rules and parameters above to tests already sent to the
results sent or print
destination or in print locked status
locked
Positive results for IFA tests are flagged as abnormal in the configuration, and running the validation with
the parameters displayed, will automatically validate all negative results (and send them to the LIS), and
will invalidate all positive results.
Review is a status intended to flag tests for later review.
Launch the validation process clicking Submit. A window with the process details pops up.
When the validation is complete, a summary of the process is displayed, with the list of invalidated tests,
validated tests, and changes made to orders.
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6.7.3.2 Manual confirmation (with images)
Results can also be confirmed manually from the validation screen with images (IFA  IFA Sessions 
Review  Click an image). To confirm a result, just click the Validate button:
This action will confirm the current test result and transmit it to the LIS.
If the test has any pending dilution with no result, a warning message is displayed to avoid validating
without realizing those pending dilutions:
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6.7.3.3 Manual confirmation (Order screen)
Any test result can be confirmed from the order screen:
To change the status of an individual test, click the test Status button as shown above. A list of
available statuses will be displayed:
The status button is disabled if the application user does not have sufficient rights
to modify it.
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It is also possible to validate a group of tests with the buttons on top of each chapter (a chapter is a
group of tests ordered as the user defines in the configuration):
Possible options are the same as if using the individual status button:
Confirmed Review Sent
Result w/o validation

Technically Approved
Click any of the above button to change the status of all tests with a result in the same chapter. Tests
with no result will remain unmodified.
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6.8 Order screen
This screen displays the order details.
The following elements are available in this screen:
REQUESTS STATUS. Click this button to show available

options that can be performed on a request:
PATIENT DEMOGRAPHICS. Order number, order date,

diagnosis, ICU ID (if available), service, doctor,
surname, name, age and gender of the patient are
displayed.
The magnifying glass opens the patient screen
displaying all orders received for the same patient.
CHAPTER HEADER. Chapter name and status buttons
EIA/CIA TEST. Name of the test, test status button,

quantitative and qualitative results are shown
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IFA TEST: These are the details displayed for an IFA test:
TEST NAME: Full name of the test as configured:
TEST STATUS BUTTON: Display the test’s status. Use it to manually

change the test status.
TEST RESULT: This is the result for the test that will be transmitted
to the LIS. Positive results are red. Negative results are black.
DILUTION RATIO: The table has a row for each dilution of the test.
The list of available dilution ratios can be customized.
DILUTION EXECUTION INDEX: QUANTA Link keeps track of the

times a dilutions has been run. If a dilution is repeated, the index
will be incremented to reflect the additional run for the dilution.
ESTIMATED: This checkbox is used to identify if the dilution has

been actually run (unchecked) or is just used to assign a result to
the test (checked).
DILUTION RESULT: Assign a result to the dilution. Positive results
have a red background. Negative results have a black
background. The list of results and positivity level can be
customized.
DILUTION PATTERN: Select up to three patterns for the current

dilution. The list of available patterns can be customized.
IFA SESSION DETAILS: Details of the session ID and slide where

this dilution can be found are shown in this field.
DILUTION IMAGES: Use this button to see the images attached to

the current dilution.
DILUTION COMMENTS: Enter comments to the selected dilution. If
there are no comments, the text bubble will be black. It is filled
with white when containing any comment.
DILUTION HISTORY: All changes made to dilution result or patterns
are logged and can be seen by clicking this button.
REPEAT DILUTION: Click this button to repeat the current dilution.
It will increase the dilution execution index by one.
DILUTION LIST: The list of available dilution ratios are displayed in

this matrix. The list can be customized. It uses the same color
code explained in previous sections.
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6.8.1 Order status
Operations availabe in the order status can be accessed by selecting the status icon to the left of the order
number in the Order screen. and are the common status icons.
The following are the options when accesing the order status:
Close order
If all tests in the order are in a final status (confirmed), this option allows closing the order to prevent it
from being modified.
Orders can be closed automatically as an automated task.
The order status icon changes to a green check mark ( ) to indicate that the request has been closed
and finished.
All tests display an icon to indicate that the request has been closed and results cannot be modified ( ).
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If any test in the order is not in a final status, a warning message is displayed.
If the current order is closed, the button changes it function to Open ( ), allowing to reopen
the order in case any modification is required. Only designated users can open a closed order.
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Cancel order
This action cancels all tests in the order. A cancellation reason must be entered when cancelling an
order.
The list of cancellation reasons can be customized to reflect the laboratory needs:
The order icon changes to reflect the cancelled status ( ). When a order is cancelled, the order
status menu displays the cancellation reason and the cancel action changes to ‘Show patient history’.
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Add new tests
This action opens a window to allow the operator to add new tests to the order.
Any test from any section (IFA, EIA or CIA) configured in QUANTA Link can be added to the current
order.
IFA tests are presented along with the corresponding list of dilution ratios so that the operator can select
any dilution to run the new test, not just the screening one. Only operators with the appropriate
priviledges can add new tests to a order.
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Show patient history
This action opens a window with all results in the system for the current patient:
Each column displays the order number and date. Each row displays a test.
Positive results are white letters with a red background, negative results are white with a blue
background and pending results are grey.
If a test has no text for a request means that the order did not have that test requested.
If any image is available for an IFA test, a magnifying glass icon is displayed by the dilution result ( )
Use the ‘Sections’ button ( ) to filter what sections are shown in the result list:
When the sections have been selected, click History to save the changes and return to the patient history.
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Show containers list
This action opens a window with the sample tubes details:
The list includes the following information:

• Tube status: this button displays the current status of a sample tube. Click it to enter an event to
reject the tube. If the tube is cancelled, tests cannot be processed in the application.
When cancelling a tube, a warning message is presented to the user to confirm the action, as all tests
using this tube will be affected.
Available statuses are:
Received OK
Cancelled
Click the status icon for a cancelled tube to remove the container event and return to ‘Received’.
A warning message is presented to the operator to confirm this action:
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• Label: Sample identification string. This is the barcode attached to the tube that will be read in
processing instruments.
• Container: tube description as configured in the application.
• Event: if the tube has been cancelled, the cancellation reason is displayed in this field.
• Sample Bank: shows the position of the sample in the Sample Bank
• Date: shows the date when the tube was received in the laboratory. Most of the time this will be
the same as the request date, as the system automatically marks tubes in a request as received
when the order is downloaded from the LIS. However, this can be different depending on the
application configuration.
• Print label: the barcode label can be printed clicking this button:
Send to host
This action uploads all results for the current request to a Host system.
Host transmission requires a specific action to be selected.
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Click the Action selection box to choose one of the available actions:
If there is more than one LIS connection configured in the system, click the Host selection box to select
the connection to use for this transmission:
When both fields are configured as desired, click Submit to upload the request information to the
selected Host.
Page 136
Show the log
This action shows the request activity log for the current order:
Each time the order is viewed or modified, QUANTA Link saves that event in the log for future review.
Page 137
6.9 Patient screen
The patient screen can be accessed by selecting the information button to the right of the patient
information in the Order screen
Page 138
This screen shows the patient information and all orders in the system for the selected patient.
Available information includes:
Full name At the top of the demographics, the full name is displayed as ‘Surname, Name’
Surname Patient surname
Name Patient name
SSN Social Security Number
Hospital No. Hospital record number for this patient

NHS National Health System number
Pass Passport number
Gender Patient gender. Options are: Male, Female, Unknown
DOB Date of birth
Page 139
6.10 Adding tests and profiles
Profiles are displayed on the Order screen as groups of tests
To display the prompt to add additional Tests to an Order, click the ‘?’ next to the Patient Name:
To manually order a profile, click the purple question mark button next to the request label and
select the Add new Tests option:
Among the individual Tests, users may also choose “Profiles” to add groups of like tests. To select
Page 140
a Profile, mark the box next to the desired profile and click Submit:
Required analytes for the selected profile will automatically be added to the order. The user may
select any additional analytes to be run from that profile. After selecting the desired analytes, the
user must select Send to request the results from the analyzer:
Page 141
6.11 Atlas
The Atlas screen contains the images stored for use inside or outside the application. These images are
not linked to patient information.
The operator actions available in the Atlas include:
ATTACHMENT: Open the file browser to add an image into the local hard drive or
network drive in the current Atlas.
MICRO: Open the screen to manage and capture images from a compatible camera
connected to the system.
PASTE: Paste an image copied in the computer clipboard into the Atlas.
EXPORT: Export filtered selection to a zip file that can be imported into another
QUANTA Link atlas
IMPORT: Import existing QUANTA Link atlas export
Page 142
Click an image to open the full screen and to enable access to editing the image attributes.
The operator actions available on images include:
ZOOM SLIDER: Change the zoom level of the image using the sliding bar.
ZOOM: Activate the 2x zoom magnifying glass. Double clicking the
image will zoom in, double right clicking on the mouse will zoom out.
ADJUST: Auto-fit the image to the current screen size. It can also resize
the image after a zoom to see the full image.
FITC: Change the status of the FITC filter. If the FITC filter is on, this
button will turn it off. The FITC layer is identified by the fluorescence
stain of the image (green).
DAPI: Change the status of the DAPI filter. If the DAPI filter is on, this
button will turn it off. The DAPI layer is identified by the blue DNA stain
of the image.
IMAGE OPTIONS: Image management options include:
• Copy to clipboard: Copy current image into the clipboard

• Send to Atlas: Copy the image to the selected Atlas. There is a
button for each Atlas defined in the application.
• Save: Save the image to the hard drive.
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INFO: Edit the image attributes
Available fields includes: title, description, key words, rate and

comments
DELETE: Remove an image from the Atlas. A warning message is
presented to prevent accidental deletion of images:
SAVE: Store the image in the hard drive in JPEG format. Once saved,
the image can be edited or e-mailed.
BACK: Save all changes then return to the Atlas image list.
Page 144
6.12 Statistics
Statistics based on data in QUANTA Link can be generated and reviewed.
Once Statistics have been enabled, the user with permissions to see Statistics will see a new icon on the
left side of the client
Click on the icon to open QUANTA Link Statistics
Page 145
Select Generate to run a Statistic
Click on the statistic or the icon and select Run to generate a statistic
Date ranges should be entered at this time and options marked as modifiable in the statistic can be
changed at this time
Page 146
Once all parameters have been entered, clicking Submit will allow the user to run the statistic immediately
or schedule it
The status of the statistic will appear on screen
To view a statistic report, click on the statistic from the list
Page 147
The statistic report will appear on screen.
Reports can be saved or printed.
If multiple statistics were run, they will each appear on a page. The page number can be found at the
bottom left of the report.
To run additional statistics, close the report window, click Generate and select the statistic to run.
6.13 MyFiles
MyFiles is a repository for reports generated in QUANTA Link. Reports are saved and accessible for later
review.
To view files, select from the top left
Page 148
Previously generated files can be selected, saved and printed
To navigate out of MyFiles, select a section from the top ribbon.

Page 149
6.14 Advanced Container Search
Advanced Container Search can be used to find orders in QUANTA Link with specific results or order
data.
Results can be filtered by
TEST: Select one test
NUMERIC RESULT: Select result range
INTERPRETED RESULT: Select individual or multiple test
PATTERN: Select pattern or multiple patterns
SECONDARY RESULT: Select secondary result pattern
ORDER FROM: Select order date range
RECEPTION DATE FROM: Select reception date range
AGE FROM: Select age range of patient at time of reception
DIAGNOSIS: Select diagnosis
INSTRUMENT: Select one or more instruments where results were generated

STORED IN SAMPLE BANK: Select whether or not results should come from
samples stored in the Sample Bank
Page 150
LIMIT NUMBER OF RESULTS TO: Limit number of results returned from seach to
specific number or random
Results returned based on the search can be filtered again or printed
Additional columns can be displayed using the Options button
Page 151
Operational Precautions and Limitations CH. 7
CHAPTER 7: Operational Precautions and Limitations

Read this manual carefully before operating the QUANTA Link® system. Operators of this system must
be trained in general laboratory techniques, safety practices and the specific requirements for operating
the QUANTA Link® system.
All functions performed within the context of preparing, performing and completing a run should be
performed with caution and with general respect both to the instrumentation and to associated
chemicals, samples and other devices.
Alterations to the software program can adversely affect performance of the assays and is the operator’s
responsibility.
7.1 Operational Precautions and Limitations
• New adaptations, modifications and alterations to the software program provided by Inova must be
introduced with caution and be thoroughly validated by the user.
• All functions performed within the context of preparing, performing and completing a run should be
done with caution and care and with general respect both to the instrumentation and to associated
chemicals, samples and other devices.
• If the dilution ratios configuration is not exactly matching that in QUANTA-Lyser, results could be
assigned to the wrong dilution. It is critical to make sure that both dilution ratios are the same for
every test in both devices.
• If the slide type configuration does not exactly match the method configuration in QUANTA-Lyser ,
results will be assigned to the wrong test. It is critical to make sure that slide types are the same
for all methods in both devices.
• Result translation must match the result receive from the instrument or unexpected results might
be generated
• If parameters defined in the rules are wrong, unexpected results might be generated
• If the relation between dilution results and test results is wrong, automatic calculated results will be
wrong.
• If the Negative result assigned for a test is wrong, using the ‘Negative’ button will return wrong
results for the dilution and the test.
• Errors in test definition, communication properties, rules definition and IFA pattern configuration
can lead to potential errors in system communications, auto titer and rules execution.
Page 152
Potential Hazards CH. 8
CHAPTER 8: Potential Hazards
Read this manual carefully before operating the QUANTA Link® system. Operators of this system must
be trained in general laboratory techniques, safety practices and the specific requirements for operating
QUANTA Link® system.
All functions performed within the context of preparing, performing and completing a run should be done
with caution and care and with general respect both to the instrumentation and to associated chemicals,
samples and other devices.
Alterations to the software program can adversely affect performance of the assays and is the operator’s
responsibility.
8.1 Potential Hazards
NOTE: New adaptations, modifications and alterations to the software program provided by Inova must
be introduced with caution and be thoroughly validated by the user.
QUANTA Link software does not pose a hazard to the user.
Page 153
Service and Maintenance CH. 9
CHAPTER 9: Service and Maintenance

QUANTA Link software does not require any maintenance by the operator. Refer to the computer hardware
operators’ manual for the specific service and maintenance that is required.
Page 154
9900 Old Grove Road
San Diego, CA 92131
United States of America
Technical Service (U.S. & Canada Only): 877-829-4745
Technical Service (Outside the U.S.): +1 858-805-7950
[email protected]
www.inovadx.com
LINK1041 Rev. 0
April 2, 2020
Page 155

LINK1041 Operators Manual

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Inova Diagnostics, Inc.

Document Number: LINK1041

IMPORTANT: Please read carefully before using

1.2 Product description ............................................................................ 8

1.3 Software description ........................................................................... 8

1.4 Hardware description ......................................................................... 9

4.2 Electrical requirements .................................................................... 13

4.3 Power consumption .......................................................................... 13

4.4 Instrument noise ............................................................................... 13

4.5 Physical Specifications .................................................................... 13

5.2 QUANTA Link functional areas ........................................................ 15

5.4 IFA reagent area ................................................................................ 19

5.5 EIA reagent area ................................................................................ 20

5.6 CIA reagent area................................................................................ 21

5.7 Connections Screen ......................................................................... 22

5.8 Orders ................................................................................................ 23

5.9 Sample bank ...................................................................................... 27

5.10 QC Management Area ....................................................................... 32

5.11 Atlas reference area .......................................................................... 33

5.12 Common operator actions ............................................................... 34

CHAPTER 6: Operating Instructions ........................................ 38

6.2 Navigation buttons............................................................................ 39

6.3 Dashboard functional area ............................................................... 39

6.4 IFA Section ........................................................................................ 42

6.6 QC Overview ...................................................................................... 90

6.7 Entering Results.............................................................................. 105

6.8 Order screen .................................................................................... 127

6.9 Patient screen.................................................................................. 138

6.10 Adding tests and profiles ............................................................... 140

6.11 Atlas ................................................................................................. 142

6.12 Statistics .......................................................................................... 145

6.13 MyFiles ............................................................................................. 148

6.14 Advanced Container Search .......................................................... 150

CHAPTER 1: Intended Use

1.2 Product description

1.3 Software description

Interaction with data between each layer is accomplished using:

• Oracle 12c (recommended version 12.2.0.1)

Minimum hardware requirements are:

HARD DRIVE MINIMUM 500 GB 500 GB 500 GB

USB PORTS MINIMUM 3 3 3

NETWORK INTERFACE 1,000BASE-T/GIGAETHERNET 1,000BASE-T/GIGAETHERNET 1,000BASE-T/GIGAETHERNET

KEYBOARD & MOUSE REQUIRED REQUIRED REQUIRED

SERVER SPECIFICATIONS 0 TO 250 251 TO 1,000 >1,000

HARD DRIVE MINIMUM 500 GB 3 X 200 GB 3 X 300 GB

NETWORK INTERFACE 100/1,000BASE-T 100/1,000BASE-T 100/1,000BASE-T

WINDOWS 7, 8.1 OR 10 OR WINDOWS 7, 8.1 OR 10 OR

2.1 Electrical requirements

Review hardware configuration manual to determine electrical requirements.

CHAPTER 3: Principles of Operation

The following scheme summarizes the software configuration:

All information is stored in the Database Server.

Current connections include:

CHAPTER 4: Performance Characteristics and Specifications

4.1 Electrical power

4.2 Electrical requirements

4.3 Power consumption

4.4 Instrument noise

4.5 Physical Specifications

CHAPTER 5: Overview of User Interface