LIS-LINK

INTERFACE

OPERATOR MANUAL

dynex.com
 LIS-Link
Operator Manual

Part No. 91001020

 Revision History

Revision History
Manual Revision Revision Date
03 2023-02-15

Manufacturer and European Authorized Representative

DYNEX Technologies, Inc.
14340 Sullyfield Circle
Chantilly, Virginia 20151 USA
Phone: +1 (800) 288-2354
Fax: +1 (703) 631-7816

EU Importer: DYNEX Technologies GmbH

Heerweg 15D, 73770
Denkendorf, Germany
Phone: +49 (0) 711-900349-66
Fax: +49 (0) 711-900349-68

DYNEX Technologies, Inc.

UK REP
Second Floor,
3 Liverpool Gardens,
Worthing,
West Sussex, BN11 1TF
United Kingdom

Acorn Regulatory Consultancy Services Limited

EC REP Knockmorris,
Cahir, Co. Tipperary,
E21 R766 Ireland

Technical Support
For technical support please contact DYNEX Technologies.

USA AND CANADA

Phone: +1 (800) 288-2354 option #4 for USA and Canada
Email: [email protected]
Fax: +1 (703) 803-1441 for US and Canada

© 2023 DYNEX Technologies Inc. ii Part No. 91001020

EUROPE
Phone: +49 (0) 711-900349-66
Email: [email protected]
Fax: +49 (0) 711-900349-68
ASIA
Email: [email protected]

At the end of life for the instrument, contact DYNEX technical support to
arrange for disposal.

All claims made in this manual have been made by DYNEX acting as the
responsible body for DYNEX branded products.

Copyright
Copyright© 2023 DYNEX Technologies, Inc. (DYNEX). All rights reserved. This material may not
be reproduced or copied, in whole or in part, without the written permission of DYNEX
Technologies, Inc.

DYNEX® is a registered trademark of DYNEX Technologies, Inc.

 Table of Contents

Table of Contents
Chapter 1: Safety Information ............................................................................ 1
1.1 Intended Use ....................................................................................................... 1
1.2 Use of the Operator Manual ................................................................................ 1
1.3 Text Conventions Used in this Manual................................................................. 1
1.4 Symbols .............................................................................................................. 2
Chapter 2: Introduction ...................................................................................... 3
2.1 Workflow ............................................................................................................. 4
2.2 Connection Options ............................................................................................. 5
2.3 Communication Protocols .................................................................................... 5
2.3.1 References .................................................................................................... 6
2.4 System Requirements ......................................................................................... 6
2.4.1 PC Requirements – Windows 7 ..................................................................... 6
2.4.2 PC Requirements - Windows 10 (Professional Version) ................................ 7
2.5 Installation ........................................................................................................... 7
Chapter 3: LIS-Link Configuration ..................................................................... 9
3.1 Communications ................................................................................................ 10
3.2 Customize Defaults ........................................................................................... 12
3.3 Aborted Assays ................................................................................................. 13
3.4 Query Style........................................................................................................ 15
3.5 Name Mapping .................................................................................................. 15
3.5.1 Configuration ............................................................................................... 16
3.5.2 Select Result Types ..................................................................................... 16
3.5.3 Remove Name Mapping .............................................................................. 17
3.5.4 Entering a New Name Mapping ................................................................... 17
3.5.5 External Pipetting Plate................................................................................ 17
3.5.6 View and Edit Name Mapping ...................................................................... 20
3.6 Vendor............................................................................................................... 21
3.6.1 Remove Vendor ........................................................................................... 21
Chapter 4: Application Configuration ............................................................. 23
4.1 DSX and REVELATION DSX ............................................................................ 23
4.1.1 System Configuration................................................................................... 23
4.1.2 Entering a New Name Mapping ................................................................... 24
4.2 DS2 and DS-MATRIX ........................................................................................ 27
4.2.1 System Configuration................................................................................... 27
4.2.2 DS-Matrix Assay Names .............................................................................. 29
4.3 AGILITY ............................................................................................................ 29
4.3.1 System Configuration................................................................................... 29
Chapter 5: Quantiferon-TB (QFT)..................................................................... 33
5.1 Query for Test Orders (LIS-Link to Host) ........................................................... 33
5.2 Test Order Response from Host to LIS-Link ...................................................... 33

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5.3 Test Complete – Send Results to Host .............................................................. 34

Chapter 6: LIS Link User Interface and Functions ..........................................35
6.1 Menu Bar .......................................................................................................... 35
6.1.1 System ........................................................................................................ 35
6.1.2 Operations ................................................................................................... 38
6.1.3 Export Results Information to HTML File ..................................................... 39
6.1.4 Help ............................................................................................................. 43
6.2 Toolbar .............................................................................................................. 43
6.3 Assays .............................................................................................................. 44
6.3.1 Assay Results.............................................................................................. 44
6.3.2 Aborted Assays ........................................................................................... 45
Chapter 7: Transmission of Information to a Host System............................47
7.1 Control and Standard Transmission Format ...................................................... 48
7.2 Example of Routine Data Exchanges ................................................................ 49
7.3 Outgoing Query to Host ..................................................................................... 49
7.4 Incoming Test Orders from Host........................................................................ 49
7.4.1 Outgoing Results from Host ......................................................................... 49
7.4.2 Host Message Framing................................................................................ 51
7.4.3 Order by Proxy ............................................................................................ 52
Acronyms .....................................................................................53

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 Chapter 1: Safety Information

Chapter 1: Safety Information

This chapter describes the text conventions and symbols that are used in this manual and it
provides important information that must be read and understood before using the DYNEX®
Laboratory Information System (LIS)-Link application.

1.1 Intended Use

LIS-Link is used to provide a bi-directional interface between a LIS or Laboratory Information
Management System (LIMS) host and a DYNEX automated Enzyme-Linked Immunosorbent
Assay (ELISA) Analyzer.

1.2 Use of the Operator Manual

Before using the LIS-Link software, it is essential that the contents of this Operator Manual are
read and understood by the operator. Always keep this Operator Manual near the instrument for
easy access to operating instructions.

1.3 Text Conventions Used in this Manual

To convey information readily and consistently certain text conventions are used throughout this
manual. The text conventions are shown in Table 1.
Table 1: Text Conventions and Purposes
Text Convention Purpose
Numbered procedures that should be implemented in order during an
operation:
Numbered Lists
1. Query sent successfully from LIS-Link to the LIS Host.
2. Orders received from the LIS Host and posted in LIS-Link.
Designates a term or component that is being described and may also
be shown in a screen shot:
The well template is used to specify the orientation of the worklist
Bold Type progression, the number of replicates that are tested for each
sample and the well type in each position on the plate.
The name of an operation button:
Select Save from the menu.
Designating another chapter of this manual that should be consulted or
designating the name of a screen:
Refer to the Appendix for additional information.

Italics The name of a window, a dialog box, pane or field:

Select Open from the Assay menu to display the Assay Protocol File
dialog box.
In the Temperature pane, select the radio button corresponding to
the temperature at which the plate will be incubated.

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 Chapter 1: Safety Information

1.4 Symbols
Symbols are used in this manual to provide a ready visual reference. The symbols and their
purpose are shown in Table 2.

Table 2: Symbols and Purposes

Symbol Purpose
Caution: Indicates a possible hazardous situation which if not avoided
can result in minor or moderate personal injury.

Information: Indicates a possible hazardous situation which if not

avoided can result in damage to the system.

 Note: Provides background or incidental information concerning the

current topic or procedure.
Complies with relevant European Union (EU) directives regarding
safety, health and environmental protection.

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 Chapter 2: Introduction

Chapter 2: Introduction
LIS-Link is an optional software package that can be installed on the DSX® Personal Computer
(PC), DS2® PC or AGILITY® instruments. It allows the Analyzer to communicate with the
laboratory host computer (LIS or LIMS) to download pending test orders and to upload
completed assay results. Lis-Link runs a Windows® service that starts when the PC starts.

Note: LIS-Link service can be started or stopped via Windows Task Manager.
LIS-Link provides a link between a customer’s LIMS and DYNEX’s REVELATION DSX®, DS-
MATRIX® and Agility applications. LIS-Link consumes a results file generated from the
instruments and allows the user to forward the results in the industry standard format to the
customer’s LIMS.

DS-Matrix

LIMS XML ASTM

Data Data
LIMS XML File
Raw Data LIS-Link LIMS
Translator Assembly

REVELATION DSX

AGILITY
LIMS XML File

Figure 1: LIS-Link Interface Diagram

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 Chapter 2: Introduction

2.1 Workflow
Listed below are the steps for using LIS-Link.
1. The user scans barcoded sample tubes.
- or -
The user manually enters sample identification information.
2. LIS-Link queries the host LIS or LIMS.
3. The host responds to LIS-Link with a correctly formatted set of test orders.
4. The DYNEX Analyzer processes the samples according to the steps of the assay
file and performs data reduction to create the results.
5. When the instrument has completed processing the samples and generating the
results, the results are posted to LIS-Link.
6. The user opens the LIS-Link Graphical User Interface (GUI), selects the assay
and initiates the transmission of results.
7. The user clicks an icon in LIS-Link to transmit the successfully imported results to
LIS Host.
LIS-Link provides a link between a customer’s LIMS and the following DYNEX instruments:
• Agility
• DSX
• DS2.
LIS-Link consumes a results file generated by REVELATION DSX, DS-MATRIX or Agility and
forwards the results in industry standard format to the customer’s LIMS.
When testing the software, the following steps must be followed in the listed order:
1. Query sent successfully from LIS-Link to LIS Host.
2. Orders received from LIS Host and posted in LIS-Link.
3. Sample IDs automatically checking off when an assay is added to the worklist.

Figure 2: Event Flow

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Figure 3: Basic Components of LIS

These steps must all be performed in the specified order. If Sample IDs are not checked off
when creating a worklist (Figure 2, step 3), the worklist cannot be executed and the results will
not be generated. Steps 1 - 4 must be successfully executed before results can be transmitted
to the LIS Host.
Note: If the checkmarks are not automatically populated there is a problem,
generally with name mapping, between LIS-Link and the DYNEX instrument
operations application. Refer to Chapter 3.5.
The software has been modified to accommodate an external pipetting feature for LIS-Link
version 2.40 and greater. The feature runs the read-only assays specified by the external
pipetting systems and automatically posts the results in LIS-Link.

2.2 Connection Options

LIS-Link allows two types of connectivity to LIS:
• Recommended Standard (RS)-232 serial connection
• Transmission Control Protocol/Internet Protocol (TCP/IP) Ethernet or RJ45 network
connection.

Note: DYNEX currently supports ONLY the RS-232 serial connection. All
instructions in DYNEX documentation assume that a serial connection
is being used.

2.3 Communication Protocols

Communication protocols are formal descriptions of digital message formats and rules. They are
required to exchange messages in or between computing systems and are required in
telecommunications.
DYNEX uses Clinical and Laboratory Standards Institute (CLSI) LIS01-A2 and CLSI LIS02-A2.
LIS-Link implements the ASTM International protocol to communicate with the hospital’s LIS.
ASTM International standards documents can be obtained from the ASTM International web site
(http://www.astm.org).

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2.3.1 References
In 2001, ASTM International Committee E31 restructured and transferred responsibility for
E31.13 standards to the National Committee for Clinical Laboratory Standards (NCCLS) (now
CLSI).
Table 3: CLSI Documents
Standard Number Description
“Specification for Low-Level Protocol to Transfer Messages Between
Clinical Laboratory Instruments and Computer Systems; Approved
CLSI LIS01-A2 Standard – Second Edition”
Replaces ASTM International Standard E1381.
“Specification for Transferring Information Between Clinical Laboratory
Instruments and Information Systems; Approved Standard – Second
CLSI LIS02-A2 Edition”
Replaces ASTM International Standard E1394.

Note: The standards must be obtained directly from CLSI, https://clsi.org.

2.4 System Requirements
To run LIS-Link a PC with Microsoft® Windows® 7 or 10 (Professional Version) Operating
System (OS) is required.

2.4.1 PC Requirements – Windows 7

Minimum PC requirements:
• Intel ® Core™/Core2 0153/Pentium ® /Celeron ® family (or compatible processor)
P P P P P P

recommended
• 10 gigabytes (GB) or larger hard drive with at least 100 megabytes (MB) of free space
• Microsoft Windows 7 Professional operating system (32- or 64-bit)
• Super Video Graphics Array (SVGA) compatible display adapter (card or built into
motherboard) with 24-bit (true-color setting) or more colors at 1024 x 768 or more
resolution
• Display properties should be set to a desktop area of at least 600 x 800 pixels and a
color palette of at least 256 colors
• Minimum 256 MB of Random Access Memory (RAM)
• Two RS-232 serial ports may be needed:
o LIS-Link
o Communication with DYNEX instrument
• One unused Universal Serial Bus (USB) port
• Mouse or other pointing device (i.e., trackball) supported by Microsoft Windows
• Microsoft Windows compatible printer (color recommended)
• Compatible sound card
• Network/Local Area Network (LAN) connection, 10/100 network interface (optional).

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• 1.8 gigahertz (GHz) minimum processor clock speed required (2 GHz or higher
processor clock speed recommended).
• One unused RS-232 serial port is required for connecting the computer to LIS-Link
• One unused USB port or RS-232 port is required for connecting the computer to the
instrument
• Microsoft Windows compatible Compact Disk-Read Only Memory (CD-ROM) or Digital
Video Disk (DVD) drive.

2.4.2 PC Requirements - Windows 10 (Professional Version)

Minimum PC requirements:
• 1 GHz or faster processor or system-on-a-chip (SoC) 10 GB hard drive disk with at least
100 MB of free space
• 2 GB for 32-bit or 4 GB for 64-bit RAM
• Microsoft Windows 10 Professional Version (32-bit or 64-bit) OS
• 16 GB for 32-bit OS or 20 GB for 64-bit OS hard drive disk space
• DirectX 9 or later with Windows Display Driver Model (WDDM) 1.0 driver graphics card
• Display properties should be set to a desktop area of at least 600 x 800 pixels and a
color palette of at least 256 colors
• One unused RS232 serial port may be required for connecting the computer to the
instrument
• One unused USB port may be required for connecting the computer to the instrument
• Mouse or other pointing device supported by Microsoft Windows 10
• Any printer that is supported by Microsoft Windows 10 can be used
• Compatible sound card.

2.5 Installation
Confirm that the DYNEX control instrument application has been installed and that the
instrument is fully operational and tested prior to the installation or setup of the LIS-Link
software. Instructions for the installation of the application is outside the scope of this document,
except for specific settings to enable LIS-Link functionality.
LIS-Link software is distributed on a Compact Disk (CD) or USB.
1. Log onto the PC using a login with Windows administrator privileges.
a. Installing from a CD:
• Insert the CD into the CD-ROM drive.
• Double-click on setup.exe.
• Follow instructions as they are displayed on the screen.

Note: DS-Matrix or REVELATION must be installed on the PC prior to the

installation of LIS-Link.
b. Installing from a USB:

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• Copy the zipped file from the USB to the desktop prior to installation.
• Unzip the file.
• Double-click on setup.exe.
• Follow the instructions that are displayed on the screen.
2. After installation has completed, reboot the PC.

Note: If the user is not familiar with installing a program from a zipped file, it is
recommended that the user contact their Information Technology (IT)
department for assistance.
The first time the software is run, the user MUST be logged on to the Windows PC as an
administrator. Routine operation of the DYNEX instrument and associated software does not
require Windows administrator privileges.
Both the DSX and DS2 control computers require a 9-pin RS-232 serial interface connector for
interfacing to a laboratory host LIS system. The Agility Universal Serial Bus (eBox) may have a
USB port with a USB/9-pin serial adaptor or a direct 9-pin RS-232 port.
Laboratory IT personnel are responsible for establishing the physical connection and enabling
communication between the Laboratory Host System (LIS Host) and the instrument control
computer. DYNEX recommends that the laboratory IT personnel perform preliminary tests to
assure that the connection is functional.

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 Chapter 3: LIS-Link Configuration

Chapter 3: LIS-Link Configuration

The last step of the LIS-Link Installer is to setup the system configurations. The default
password is “DYNEX”. Refer to Chapter 6.1.1.2 for steps on changing the password.
If configuration updates are not performed at this time, they can be performed in the future by
opening the LIS-Link Graphical User Interface (GUI).

Figure 4: System Configuration

Table 4 lists the system options fields and provides a description.

Important: All fields are required.

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 Chapter 3: LIS-Link Configuration

Table 4: System Options Fields

Field Description
• Results files from the instrument – the files are quickly
processed and deleted.
• Error and status logs are in subfolders of this location.
• The instrument software and LIS-Link MUST agree on this
data path.
Data Path
Note: When the data path is entered in LIS-Link before
enabling LIS in DS-MATRIX or REVELATION DSX, the
data path will match. If the data path is changed after LIS
is enabled in either application, the enable LIS option
must be unchecked and then enabled again to have the
correct data path display.
Laboratory designation for the instrument.
Machine Name Note: It is recommended that the instrument serial
number is used.
Local Computer Name Enter the name of the PC even if it is not networked.

3.1 Communications
The Communications tab allows the user to enter the physical connection parameters for the
interface between the instrument and LIS Host computer.

Note: All settings, other than the COM port number, need to match the serial
communications settings used by LIMS.

Note: It may take some experimentation to identify the COM port to which the
serial cable is attached. Consult an internal IT professional who is familiar with
serial communications for assistance.
1. Click System → Configuration → Communications.
2. Figure 5 displays the recommended settings.

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 Chapter 3: LIS-Link Configuration

Figure 5: Communications Recommended Settings

Important: Avoid using any serial COM port number above 9. (LIS-Link will
NOT be able to use any number above 9).
3. Select Serial if using a RS-232 cable or TCP/IP if using an Ethernet cable.

Note: DYNEX does NOT support the use of TCP/IP. We recommend using a
RS-232 cable.

Note: If Serial Settings is selected, TCP/IP Settings are greyed out. If

TCP/IP is selected Serial Settings are greyed out.
Table 5 provides a description of the fields in the Communication tab.
Table 5: Communications Fields
Field Description Options
Serial Settings
Technique that checks whether data has been lost or written • Even (E)
Parity over when it is moved from one place in storage to another or • None (N)
when it is transmitted between computers. • Odd (O).
• 2400
• 9600
Baud Rate Communication speed measured in bits per second. • 14400
• 19200
• 38400
• 7
Data Bits Number of bits to encode one character.
• 8
• 1
Stop Bits Time between transmitted characters.
• 2
COM Port Port on the computer that the serial line is connected to.
Use Hardware Flow Manages the flow of information between the systems.

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 Chapter 3: LIS-Link Configuration

Field Description Options

Serial Settings
Control
Use Hardware Flow C or Do NOT use hardware flow control to manage the flow of
NO_HW_FLOW information between the systems.
Enable Cyrillic/Unicode
Enable Cyrillic characters for use
for DS-MATRIX
TCP/IP Settings
LIS Hostname Name of the LIS Host computer.
Port Port number for the host's LIS application.
Communication Method
This tells the application how the machine is physically • TCP/IP
Serial or TCP/IP
connected to the computer. • RS-232
Additional
The amount of time the system will wait for a completed
Query Wait Time
message from the LIS Host before timing out

4. Indicate whether hardware flow control is used to manage the flow of information
between the systems.

5. Set the Query Wait Time up to 10 minutes. This is the delay time the system will wait for
a completed message from the LIS Host.

6. Click to save changes.

– or –

Click to save changes and exit the System Configuration window.

3.2 Customize Defaults

Note: It is recommended to make “Send” the default selection. This sets the
transmission status of new results.

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Figure 6: Customize Defaults Tab

Table 6: Customize Default Buttons

Radio button Description
Make “Leave” Default Selection Results are NOT automatically tagged for transmission to LIS.
Make “Send” Default Selection Results are automatically tagged for transmission to the LIS.
• If checked, LIS-Link accepts the results and adds them to
the LIS-Link results database. Those results are sent to
the site LIMS.
• If not checked, LIS-Link deletes the non-sample well
Send Results for Standards and
results.
Controls Wells
Note: Send Results for Standards and Controls Wells
defaults to being selected. Uncheck the box to prevent
residual results from accumulating in LIS-Link.

3.3 Aborted Assays

Choose the default status action for aborted assays, Leave for User Confirmation is
recommended.

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Figure 7: Aborted Assays Tab

Table 7: Aborted Assays Buttons

Radio Button Description
The test order will be deleted.
Make “Delete Assay Run” Default Selection
No information will be sent to the LIS.
Make “Re-run Assay Run” Default Selection The test order will be automatically re-run.
No action taken until the operator intervenes. The
Leave For User Configuration
test run status code is “Erred”.

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 Chapter 3: LIS-Link Configuration

3.4 Query Style

Choose the query style that will be used.

Note: Only query for sample IDs scanned is recommended for routine use.

Figure 8: Query Style

Table 8: Available Query Style Buttons

Radio Button Description
After the user begins the scanning setup process,
Query for all available sample IDs at one
LIS-Link will query the host computer for all pending
time
test orders.
After all scanning is completed, LIS-Link will request
Only query for sample IDs scanned
test orders for the scanned samples.

3.5 Name Mapping

The Name Mappings tab allows the user to customize LIS-Link with assay names used by LIS.
LIS can request a test order and receive result data with assay names it has assigned.
For successful exchange of information between LIS-Link and the LIS Host computer, the assay
names used by the DYNEX instrument must be linked to the assay names used by the LIS

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Host. Name mapping in LIS-Link maps the name for an assay in one system to the name used
for that same assay in the other system.

3.5.1 Configuration
1. Click System → Configuration.
2. Click the Name Mappings tab.

Figure 9: Name Mappings Tab

3. Type an assay name used by the host computer in the LIMS Name field (e.g. CVM IgG).

Note: Name mapping that is currently associated with orders or results can
NOT be changed. Before a name mapping can be edited, the associated
orders or results need to be deleted from LIS-Link.
4. Type the corresponding assay file name in the Local Assay File Name field.
REVELATION DSX® assay file names must have a “.asy” extension. (e.g. cvmigg.asy).
DS2 and Agility do not require the extension.
5. Click .

3.5.2 Select Result Types

The Name Mappings dialog also allows you to select which type of result values are reported
back to the LIS.

Note: Procedures for specifying the manner in which assay results are
calculated are defined during assay definition. Refer to the REVELATION
DSX Operator Manual for more details.
1. Click to place a check mark next to each result type to be transmitted.

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Note: Multiple selections are allowed. The final result is always a duplicate of
another selection, so duplicate data will be transmitted if final result and its
matching option are both marked.

Click to save changes.

– or –
Click to save changes and close the System Configuration dialog box.

3.5.3 Remove Name Mapping

To remove a previously entered name mapping.
1. Highlight the LIMS Name in the left panel.

2. Click to remove the selected name mapping.

- or –

Click to delete all name mappings .

Note: Deleting name mappings that are associated with orders or results will
remove the orders and results from the LIS-Link database.

3.5.4 Entering a New Name Mapping

Name mapping MUST be correct or the system will not function correctly. Mapped names are
case-sensitive and spaces used in the assay names must be reflected in the name mapping.
Important: Incorrect name mapping is one of the most common sources of
failure to implement the interface.
1. Enter the LIS Name for the assay. This must be EXACTLY as defined in the LIS Host.

Note: It is recommended to use the keyboard rather than cut-and-paste from

another location. Any unintentional character, such as an embedded space or
an incorrect case for a letter, may prevent correct mapping.
2. Enter the Local Assay File Name. This must be exactly as defined in the Agility, DS-
MATRIX or REVELATION DSX assay definitions.
a. When interfacing with REVELATION DSX, include the “.asy” extension in assay
file names.
b. When interfacing with DS-MATRIX or Agility, the “.asy” extension is NOT used.

3.5.5 External Pipetting Plate

Note: REVELATION DSX software supports external pipetting plate feature.

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Important: The assay mapping in DSX mode MUST be setup correctly for
LIS-LINK to work properly.
1. Click Tools → EppAssayMapping to ensure that the assay mapping for LIMS is correctly
configured. Ensure that the EPP File Type is set to DSX and the Lis Assay Name maps
to the correct assay in the DSX REVELATION Assay.

Figure 10: EPPEdit Assay Map Window

For example: If LIMS HOST mapping is RUBM, ensure that the LIS-LINK
mapping for REVELATION DSX assay in DSX EPP File Type matches
DSX_Rub_IgG.asy (Figure 10).
In external pipetting mode the Epp File Type is configured as TPL and the LIS Assay Name
maps to the EPP REVELATION DSX Assay.
In the LIMS assay name map (Figure 11), RUBG is mapped for external pipetting mode and
RUBM is mapped for DSX mode.

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Figure 11: Name Mapping Sorted by Final Result

2. To find the local assay file name in DS-MATRIX, start a worklist and look in the assays
column on the right hand side of the screen (Figure 13) to identify the assay name
exactly as it must appear in the name mapping (no spaces, file extensions, etc.).

Figure 12: Local Assay File Name in DS-MATRIX

3. Open the Assay Editor and select Open to display a selectable listing of assay names in
the system.
4. To find the local assay file name in DSX REVELATION DSX, navigate to C://Program
Files/DYNEX Technologies/REVELATION DSX/Assays.

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5. Identify the correct assay file. For DSX Revelation, use the name exactly as it is
displayed in this folder, complete with the “.asy” extension. For DS2 Matrix, the “.asy” file
extension is not used.

Figure 13: Name Mappings Tab

6. Enter the result types to be sent to the LIS by checking the appropriate boxes. Agility,
REVELATION DSX and DS-MATRIX applications use several modes of processing
data, each capable of generating results.
7. In addition, there is raw data and a generic “Final Result”. In most cases, the final result
will be sent across the interface. Some laboratories may also want to send raw OD data
or the results of intermediate processing. If more than the final results are transmitted,
the host system must be set to correctly receive and process multiple pieces of data for
each sample.

8. Click .
9. The mapped assay is displayed in the list on the left and the entry fields on the right will
clear.

3.5.6 View and Edit Name Mapping

1. To view a name mapping, double click on the mapped assay names in the Name
Mapping tab (Figure 13).
2. Edit Mapping... is displayed (Figure 14). This box shows the current settings for one
assay name mapping.

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 Chapter 3: LIS-Link Configuration

Figure 14: Edit Mapping

3. To edit names, highlight the name and make required changes.

4. Select or deselect result types for transmission by checking or unchecking the checkbox
for each result type.

5. Click when changes are done.

Note: Name mapping cannot be edited if there are pending samples in the
LIS-Link software for the assay. Pending samples must be deleted from the
system prior to attempting to edit name mapping for the assay.

3.6 Vendor
During installation, two files are installed, Default Protocol.dll and Vendor DLL #1.dll. They affect
the way LIS-Link formats and interprets some specific transmissions to and from the LIS Host.
Vendor customizations to the LIS interface will be considered by DYNEX software development.
Once a customization is accepted the vendor's DLL file becomes a part of LIS-Link and is made
available for selection on the Vendor tab.
1. Click System → Configuration.
2. Click the Vendor tab
3. Approved vendors are listed in the Available Vendors panel. The Status column
indicates which vendor customization is currently in use.

Note: The Default DSX protocol is selected during installation.

4. To activate a vendor DLL, highlight the vendor then click Set Active.
5. Click to save changes.
– or –

Click to save changes and close the System Configuration dialog.

3.6.1 Remove Vendor

1. Highlight the vendor in the left panel.
2. Click .

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Figure 15: Vendor Tab

Table 9: Vendor Files

Filename File Purpose
This requires the same Sample ID in both the Patient Record field
4 (P) and the Order Record field 3 (O).
Defaultven.dll
This protocol will return error messages as a Manufacturer
Record.
This requires the Sample ID in the Order Record Field 3 only. It
Vendor DLL #1.dll
will return error messages as a Result Record (R).

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 Chapter 4: Application Configuration

Chapter 4: Application
Configuration
4.1 DSX and REVELATION DSX
LIS-Link allows the DSX to communicate with the LIS to download pending test orders and to
upload completed assay results.
It allows for DSX to send queries, consisting of barcode-scanned or manually entered sample
IDs (or a query for all orders) to the LIS. DSX accepts test orders from the LIS for the specific
P

samples and properly checks for which samples are to run when the user enters those orders in
the DSX worklist. Upon completion of the actual testing, the results are paired with the correct
patient orders and put in a holding queue for user confirmation and subsequent transmission to
the LIS.

4.1.1 System Configuration

After LIS-Link has been installed and configured (Chapter 3: ) perform the following steps:
1. Start-up REVELATION DSX.
2. Click Tools → Configure System. The Setup DSX screen is displayed.

Figure 16: Setup DSX Screen

3. Click the LIS tab.
4. The Setup DSX screen is displayed (Figure 17).

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Figure 17: Setup DSX Dialog Box

5. Ensure that Enable LIS support is selected.

Note: The LIS Service Information shows the installed version, installation
directory and the data directory selected during LIS-Link setup. Check the LIS-
Link configuration and verify that both programs have the same Data Directory
(Data Path in LIS-Link).

4.1.2 Entering a New Name Mapping

Name mapping must be correct or the system will not function correctly. Mapped names are
case-sensitive and spaces used in the assay names must be reflected in the name mapping.
Incorrect name mapping is one of the most common sources of failure to implement the
interface.
1. Enter the LIS Name for the assay. This must be exactly as defined in the LIS Host.

Important: It is recommended using the keyboard rather than cut-and-paste

from another location. Any unintentional character, such as an embedded
space or an incorrect case for a letter, may prevent correct mapping.
2. Enter the Local Assay File Name. This must be exactly as defined in DS-MATRIX or
REVELATION DSX assay definitions.

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a. When interfacing with REVELATION DSX, include the “.asy” extension in assay
file names.
b. When interfacing with DS-MATRIX or Agility software, do not use the “.asy”
extension.

Note: REVELATION DSX software supports external pipetting plate feature.

Important: Configure the assay mapping in DSX mode correctly for LIS-LINK
to work properly.
c. Click Tools → EppAssayMapping to ensure that the assay mapping for LIMS is
correctly configured. Ensure that the EPP File Type is set to DSX and the Lis
Assay Name maps to the correct assay in the DSX REVELATION Assay.

Figure 18: EPPEdit Assay Map Window

For example: If the name of the test used by the LIMS host is RUBM, ensure that
the LIS-LINK mapping for REVELATION DSX assay in DSX EPP File Type
matches DSX_Rub_IgG.asy (Figure 18).
In external pipetting mode the Epp File Type is configured as TPL and the LIS Assay Name
maps to the EPP REVELATION DSX Assay.
In the LIMS assay name map (Figure 11), RUBG is mapped for external pipetting mode and
RUBM is mapped for DSX mode.

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Figure 19: Name Mapping Sorted by Final Result

3. To find the local assay file name in DSX REVELATION DSX, navigate to C://Program
Files/DYNEX Technologies/REVELATION DSX/Assays.
4. Identify the correct assay file; use the name exactly as it is displayed in this folder,
complete with “.asy” extension.

Figure 20: Name Mappings Tab

5. Enter the result types to send to LIS by checking the appropriate boxes. REVELATION
DSX and DS-MATRIX application can use up to four modes of processing data, each
capable of generating results.

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 Chapter 4: Application Configuration

6. In addition, there is raw data and a generic “Final Result”. In most cases, the final result
will be sent across the interface. Some laboratories may also want to send raw OD data
or the results of intermediate processing. If more than the final results are transmitted,
the host system should be set to correctly receive and process multiple data fields for
each sample’s test result.

7. Click .
8. The mapped assay is displayed in the list on the left and the entry fields on the right will
clear.

4.2 DS2 and DS-MATRIX

LIS-Link allows the DS-Matrix to communicate with the LIS to download pending test orders and
to upload completed assay results.
It allows for DS-Matrix to send queries, consisting of barcode-scanned or manually entered
sample IDs (or a query for all orders) to the LIS. DS-Matrix accepts test orders from the LIS for
the specific samples and properly checks for which samples are to run when the user enters
those orders in the DS-Matrix worklist. Upon completion of the actual testing, the results are
paired with the correct patient orders and put in a holding queue for user confirmation and
subsequent transmission to the LIS
Caution: If there are some sample-sets that are incompletely assigned
(some tubes assigned, some tubes not assigned) to the Quantiferon
assay, pipetting will be wrong and all samples after the incomplete
sample will be wrong. The wrong sample fluid will be placed in the wrong
plate well.

4.2.1 System Configuration

1. Double click on to open the DS2 application.

2. Click Tools → System Configuration.

Figure 21: DS2 System Configuration Screen

3. Click the LIS Options tab.

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Figure 22: DS2 LIS Options Screen

4. Ensure that Enable LIS support is selected.

After LIS-Link has been installed and configured (Chapter 3: ), perform the following steps:
1. Start-up DS-MATRIX.
2. Select Tools → System Configuration.
3. The System Configuration screen is displayed.

Figure 23: DS2 System Configuration Screen

4. Click the LIS Options tab.

5. Ensure that Enable LIS support is selected.

Note: Selecting Enable LIS Support will allow LIS-Link to support using LIS
on the sample batch when initiating the worklist (Chapter Chapter 5: ).
6. Ensure both Reprocessing Options are selected.

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4.2.2 DS-Matrix Assay Names

1. To find the local assay file name in DS-MATRIX, start a worklist and look in the assays
column on the right hand side of the screen (Figure 13) to identify the assay name
exactly as it must appear in the name mapping (no spaces, file extensions, etc.).

Figure 24: Local Assay File Name in DS-MATRIX

2. Open the Assay Editor and select Open to display a selectable listing of assay names in
the system.

4.3 AGILITY
LIS-Link provides a link between a customer’s LIMS and DYNEX’s Agility applications. LIS-Link
consumes a results file generated from Agility and forwards the results in the industry standard
format to the customer’s LIMS.

4.3.1 System Configuration

Important: Agility MUST use LIS-Link 2.01 or greater.

4.3.1.1 Available Query Styles

It is recommended, especially when using the Agility instrument, to query using Only query for
sample IDs scanned ++.
Important: This setting MUST match between LIS-Link and Agility; if this
option is selected in LIS-Link, but Agility is set to “Query all”, or vice versa,
then the query for orders will fail.

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 Chapter 4: Application Configuration

Figure 25: Query Style Tab

4.3.1.2 Name Mapping

The local assay file name for the assay can be found in the Agility software on the barcode
printing screen and on the assay selection screen.

Important: This name MUST be exactly as displayed without any file

extensions.
For example: The assay name is QFTPlus_4point_v2_RO.

Figure 26: Name Mapping Screen

4.3.1.3 Enabling LIS-Link in AGILITY

LIS-Link is enabled through a database setting in the Agility database. When LIS-Link setting is
not enabled, the Check LIS and Select LIS buttons will be grey instead of orange. If LIS-Link is

not enabled, click on the Configuration screen . Click the LIS-Link Mode drop-down
and select LIS_Link to enable the Check LIS and Select LIS buttons.

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4.3.1.3.1 System Configuration

1. Ensure LIS-Link System Configuration is enabled.

2. Click and wait for the # LIS Sample number to populate.

Note: This may take up to 10 minutes but generally takes 30 seconds to 2

minutes. If the system takes longer than 5 minutes, the query wait time may
need to be changed via LIS-Link’s configuration (Communications tab) from 5
minutes to 10 minutes; otherwise, it will time out and orders will not be
downloaded.

Figure 14: LIS Sample – Not populated

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 Chapter 4: Application Configuration

Figure 27: LIS Sample – Populated

3. Click to select sample IDs that have orders.

Figure 28: Select LIS-Link

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 Chapter 5: QFT

Chapter 5: Quantiferon-TB (QFT)

LIS-Link allows the DYNEX instrument to communicate with the LIS in order to determine which
tests should be run with which samples. When running the 4-tube QFT
Gold assay, the LIS will typically only have orders for the first tube in the multi-tube set.
When running the 4-tube QFT assay and some barcodes have not been scanned, the sample
IDs will need to be input manually. Similarly, if any of the sample tube IDs in the multi-tube set is
not automatically checked off when Select LIS is clicked, it must be selected manually.
Otherwise, the system will register that the correct number of samples were scanned but not
that the correct number were selected for the run, and the testing of the tubes in that sample
rack will be incorrect.

5.1 Query for Test Orders (LIS-Link to Host)

After barcodes are scanned, REVELATION DSX (6.12 and higher) and DS-MATRIX (1.23 and
higher) will ask the user if duplicate barcodes should be corrected with suffixes (- a and - b).
H|\^&|||LName||||||||1|20110531153846
Q|1|Jones1234||||||||||O
Q|2|Jones1234 - a||||||||||O These queries must be ignored by Host.
Q|3|Jones1234 - b||||||||||O
Q|4|Scott2345||||||||||O
Q|5|Scott2345 - a||||||||||O
Q|6|Scott2345 - b||||||||||O
Q|7|Lampel3456||||||||||O
Q|8|Lampel3456 - a||||||||||O
Q|9|Lampel3456 - b||||||||||O
Q|10|Smith4567||||||||||O
Q|11|Smith4567 - a||||||||||O
Q|12|Smith4567 - b||||||||||O
L|1|N

5.2 Test Order Response from Host to LIS-Link

The host system will normally have one order for the Sample ID with no suffixes. It will normally
be programmed to respond with one test order even though there are three tubes for each
Sample ID set for a QFT order. The LIS host name is set to “QFT” in this example.
Important: Alternative set-ups are supported, but NOT recommended by
DYNEX.

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 Chapter 5: QFT

H|\^&|||LName||||||||1|20110531153846|
P|1|| Jones1234||
O|1| Jones1234||^^^QFT|R|20040205151351
P|2|| Scott2345||
O|1| Scott2345||^^^QFT|R|20040205151351
P|3|| Lampel3456||
O|1| Lampel3456||^^^QFT|R|20040205151351
P|4|| Smith4567||
O|1| Smith4567||^^^QFT|R|20040205151351
L|1|N

Even though only one test order is returned to LIS-Link, the software has been written to check
off the appended samples on the worklist so that all three tubes are processed.

5.3 Test Complete – Send Results to Host

1. For this example, the computer was not connected to an actual DSX machine, so
the results are out of range and are marked *****.
2. The final result field is always F for final.
3. Settings in the software trigger special data processing to compute the
intermediate and final results for the multi-tube QFT assay. The results transmitted
to the host are selected in the Assay Name Mapping of the multi-tube QFT assay.
In this example, spreadsheet and final result are checked off.
H|\^&|||LName||||||||1|20110531154452
P|1|| Jones1234
O|1| Jones1234||^^^QFT|R|20110531153848
R|1|^^^QFT|*****|||DF||F||||20110531154452|MName This is Difference data.
R|2|^^^QFT^TB-Nil|*****|||DF||F||||20110531154452|MName
R|3|^^^QFT^Mitogen-Nil|*****|||DF||F||||20110531154452|MName
R|4|^^^QFT|*****|||FR||F||||20110531154452|MName This is Final Result data.
P|2|| Scott2345
O|1| Scott2345||^^^QFT|R|20110531153848
R|1|^^^QFT|*****|||DF||F||||20110531154452|MName R|2|^^^QFT^TB-Nil|*****|||DF||F||||20110531154452|MName
R|3|^^^QFT^Mitogen-Nil|*****|||DF||F||||20110531154452|MName
R|4|^^^QFT|*****|||FR||F||||20110531154452|MName P|3|| Lampel3456
O|1| Lampel3456||^^^QFT|R|20110531153848
R|1|^^^QFT|*****|||DF||F||||20110531154452|MName
R|2|^^^QFT^TB-Nil|*****|||DF||F||||20110531154452|MName R|3|^^^QFT^Mitogen-
Nil|*****|||DF||F||||20110531154452|MName
R|4|^^^QFT|*****|||FR||F||||20110531154452|MName P|4|| Smith4567
O|1| Smith4567||^^^QFT|R|20110531153848
R|1|^^^QFT|*****|||DF||F||||20110531154452|MName R|2|^^^QFT^TB-Nil|*****|||DF||F||||20110531154452|MName
R|3|^^^QFT^Mitogen-Nil|*****|||DF||F||||20110531154452|MName
R|4|^^^QFT|*****|||FR||F||||20110531154452|MName
L|1|N

This application uses the host name for the assay (QTF) and builds two additional names for
result record 2 and 3.
Result records 1-3 are identified by name and the code DF in field 7.
Result record 4 is the final result and is identified by the code FR in field 7.

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 Chapter 6: LIS Link User Interface and Functions

Chapter 6: LIS Link User Interface

and Functions
Start LIS-Link by double clicking .

Note: The default installation location of the LIS-Link.exe executable file is

C:\Program Files (x86)\DYNEX Technologies\LIS-Link.
This assumes LIS-Link is running on a 64-bit PC; if a 32-bit PC is used, the
default installation location will not contain the “(x86)” classifier.
The Main Window screen is displayed (Figure 29). After running the first assay, the Assays
folder will have results listed.

Note: If no list of assays appears, click on + to expand the list.

Menu Bar
Toolbar

Figure 29: Main Window Screen

6.1 Menu Bar

There are three options available from the Menu Bar:
• System:
• Operations:
o Update result status codes
o Initiate results transfer
o Delete assay or result data.
• Help:
o Display software version information.

6.1.1 System
The system option allows the following:

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Table 10:System Options

Option Description
Configuration Configure the communication link.
Password Modify the login password.
Exit Exit the application.

6.1.1.1 Configuration
Figure 30 shows the System Configuration dialog box.

Figure 30: System Configuration Options

The Configuration option allows the user to perform the following:
• Enter the data path, machine name and local computer name
• Set the communication method and change communication protocol settings
• Set the default status for new results
o Leave
o Send
• Specify the default status for aborted assays
o Delete Assay Run
o Re-run Assay Run
o Leave for user confirmation
• Set the available query style
o Query for all available Sample IDs at one time
▪ Occurs during barcode scanning
o Only query for sample IDs scanned

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 Chapter 6: LIS Link User Interface and Functions

▪ Done after barcode scanning is completed

• Map LIS Host names to DYNEX instrument assay file names
• Displays the available vendors.
Configuration of LIS-Link is covered in Chapter 3: .

6.1.1.2 Password
To change the login password for LIS-Link, perform the following steps:

Important: LIS-Link must be run as an administrator to change the password.

1. Click System → Password.

Figure 31: Password

2. The Change Password dialog box is displayed.

Figure 32: Change Password Dialog Box

3. Enter the current password in the Old Password field.

4. Enter the new password in the New Password field.
5. Enter the new password again in the Confirm New Password field.

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 Chapter 6: LIS Link User Interface and Functions

6. Click to change the password.

6.1.1.3 Exit
To close the LIS-Link GUI, click System → Exit.

The application may also be closed by clicking in the upper right hand corner of the title bar.

6.1.2 Operations
The Operations menu is used to update result status codes and initiate result transfers to LIS
Host.

6.1.2.1 Commit Operations

Figure 33: Commit Operations Options

6.1.2.2 Save All Selection Changes

This option commits modified transmission decisions.
Click Operations → Commit Operations → Save All Status Selection Changes to save changes.

Note: No confirmation message is displayed on the screen after the

selections are saved.

6.1.2.3 Send Data to LIS Host

This option transmits results marked “Send” to LIS.
1. Click Operations → Commit Operations → Send Data to LIS Host.
2. The data is sent to LIS Host. The screen below is displayed (Figure 34).
3. When the results are transmitted to LIS Host the screen shown in Figure 35 is displayed.

Figure 34: Returning Results to LIS

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 Chapter 6: LIS Link User Interface and Functions

4. Click to close the pop-up window.

Figure 35: Transmission Finished

6.1.2.4 Delete Operations

This option allows reported assay results to be deleted.
Click Operations → Delete Operations.

6.1.2.4.1 Delete Assays from Plate(s)

Allows reported assay results to be deleted.

Figure 36: Cancel Assay on Plate

6.1.2.5 Remove Test Results Marked Deleted

Results marked for deletion are deleted from LIS-Link without reporting the deletions to LIS.

Note: This does not delete the result from the DYNEX instrument’s database.
6.1.3 Export Results Information to HTML File
This option copies result data to a user selectable filename.
1. Select Export Results Information to HTML File from the Operations drop-down menu
2. The following is displayed:

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 Chapter 6: LIS Link User Interface and Functions

Figure 37: Exporting Dialog Box

3. Enter a title into the Document Title field.

4. Enter the name of the operator in the Operator Name field.
5. Enter a unique identifier into the Customizable ID field.

6. Click .
7. The Windows Save As dialog box opens.

Figure 38: Save Location

8. Select the save location of the HTML file.

9. Enter the filename in the File name: box.
10. Click .
Figure 39 displays an example of the report.

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 Chapter 6: LIS Link User Interface and Functions

Figure 39: HTML Exported Report

6.1.3.1 Refresh Data

This option updates the LIS-Link GUI with the latest results data from the DYNEX instrument
software. This includes assay results generated after the GUI was launched.
Perform the following steps below to refresh the data:

1. Click Operations → Refresh Data or click .

2. The following is displayed:

Figure 40: Refresh Data Dialog Box

3. Click to update the data or click to exit without updating.

 Note: The decision radio button selections will be reset. (Refer to Chapter
6.3.1.)

6.1.3.2 Maintain Database

Maintain Database option allows the operator to view data that may remain in the database after
all LIS operations have been completed.

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Important: Any data removed with this utility is NOT RECOVERABLE.

Follow the steps below to access the database viewer:
1. Select Maintain Database option from the Operations drop-down menu.
2. A dialog box asking for the LIS-Link password is displayed.

3. Enter the password in the Password field.

4. Click .
5. The LIS Database Viewer screen is displayed.

Figure 41: LIS-Link Database Viewer

Table 11: LIS Database Viewer

Item Description
Tables
The default state when the program is started. No information is in
(No Tables Selection) the content viewer, and the Remove and Remove All functions are
greyed out.
A listing of the assay file name to the LIS Assay Name. This table
Assay Name Mapping can only be viewed and not edited in the database viewer.
Assay Name Mapping can be changed in the Configuration Menu.
A listing of all the Sample IDs present in the database.
Sample ID Removal of a sample ID in this table will result in the corresponding
information in the Test Run and Results tables being deleted.

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Item Description

Test Runs The main database table.

This table contains the data from completion of an assay test. Each
Results
entry corresponds to a sample in the Sample ID table.
Activity
When a line is selected in the content viewer, the data listed on the
Remove
selected line is removed from the database.
All the data from the selected table is removed.
If used on the Sample ID table all entries are removed from the
Remove all Sample ID, Test Run and Results Tables.
If used on the Test Run table all entries are removed from the Test
Run and Results tables.
Additional
A window that shows the data in the database. Each line may be
removed or the entire table deleted if the Remove and Remove All
Content Viewer
buttons are functional.
Individual fields are not editable.
Closes the Database Viewer.
Exit Note: Changes that have been made but are not saved will
be lost when exit is selected.
Help Loads the help file for the database viewer.

6.1.4 Help
The Help menu displays LIS-Link version information.

Figure 42: About LIS-Link

6.2 Toolbar
Table 12: Toolbar Icons
Icon Description
Send all results marked “send” to LIS.
Remove test results marked as deleted.
Shows most recent status updates and results from the DYNEX instrument
software.

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Icon Description

Note: The Decision radio button selections will be removed when the
refresh is applied; to implement Decision radio-button selections to Send or
Delete results, apply the Decision status and send results to LIS before
refreshing the status updates. (See section 6.3.1.)
Allows for the user to configure the system.

Displays the LIS-Link software copyright and version information.

Opens help documentation.

6.3 Assays
Lists all assigned assay names. Assays containing results that are ready for disposition (aborted
or completed) appear in bold. The number of results pending disposition is shown in
parentheses after the assay name.

6.3.1 Assay Results

Review assay results data using the LIS-Link GUI main window.

1. Click + to view the assay list.

2. The list opens and displays all LIS assay names. Assays containing results that are
ready for disposition (aborted or completed) appear in bold. The number of results
pending disposition is shown in parentheses after the assay name.

Figure 43: Assays List Example

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 Chapter 6: LIS Link User Interface and Functions

3. Click on an assay to display the result records.

Table 13: Result Record Fields
Field Description
Sample ID Provided by LIS in the Test Order record.
Patient Name Provided by LIS in the Patient Information record.
• Erred
• Completed
Assay Status
• Queued
• Pending
Result Display Result values selected for transmission, refer to Chapter 3.5.
Decision Result status code.

 Note: Only decisions for completed assays may be modified. The default
decision (Send or Leave) is automatically selected for each result record
based on the Customize Defaults configuration setting or if the refresh button
is clicked.
4. If needed, select a different decision.

5. Click to update the decision for the individual record.

 Note: The user may wait until all changes have been made and click Apply
All.

Important: Changes are NOT preserved if the LIS-Link GUI application is

terminated before the results are transmitted to the LIS.

6.3.2 Aborted Assays

Aborted assays allow the user to determine how aborted test runs are handled.
1. Click System → Configuration.
2. Click the Aborted Assays tab.

Figure 44: Aborted Assays Screen

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3. Check to make Delete Assay Run, Re-run Assay Run or Leave for User
Confirmation the default action when an assay is aborted (Table 14).
Table 14: Actions When Assay is Aborted
Action Description
Delete Assay Run The test order is deleted. No information will be sent to the LIS.
Re-run Assay Run The test order is automatically re-run.
No action will be taken until the user intervenes.
Leave for Confirmation
The test run status code is erred.

4. Click to save changes.

– or –
5. Click OK to save changes and close the System Configuration dialog box.

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 Chapter 7: Transmission of Information to a Host System

Chapter 7: Transmission of
Information to a Host System
This section describes the communication protocol for transmission of Control and Standard
results from the DYNEX Elisa analyzers to a laboratory LIS Host system using DYNEX LIS-Link
Software. It is a low-level data protocol description of the output format of the transmission to
the host.

Important: The host system must be configured to extract the desired

information.
This functionality requires LIS-Link 2.01 or higher compatible version used together with Agility,
REVELATION DSX 6.15+ or DS-MATRIX 1.23+. With the specified software correctly installed,
configured and enabled, Control and Standard results will always be transmitted. This
functionality will not work with earlier versions of software.
This shows a typical transaction where DYNEX asks for work orders, completes the orders and
returns results to the LIMS Host. There is no change in the data flow between DYNEX and the
LIMS DSX/DS2 or in how results for test specimens are returned. What’s new here are the
returned control and standard results.
For example: The following is a typical query from LIS-Link to the LIS host for test orders. Four
samples have been scanned.
H|\^&|||DYNEXRD-LT||||||||1|20101208184458
Q|1|Jones1234||||||||||O
Q|1|Scott4567||||||||||O
Q|1|Federer2345||||||||||O
Q|1|Green6789||||||||||O
L|1|N

Upon finding orders for the four samples, the host responds with the following message:
H|\^&|||DYNEXRD-LT||||||||1|20101208184458|
P|1||Jones1234||
O|1|Jones1234||^^^ProtC|R|20040205151351
P|2||Scott4567||
O|1|Scott4567||^^^ProtC|R|20040205151351
P|3||Federer2345||
O|1|Federer2345||^^^ProtC|R|20040205151351
P|4||Green6789||
O|1|Green6789||^^^ProtC|R|20040205151351
L|1|N

In this example, the LIS host found four orders for a ProtC assay for the four samples. When the
assay is completed it returns results to the host. In this case, the sample results come first.
There is no change to specimen data transfer.
H|\^&|||DYNEXRD-LT||||||||1|20101208190753
P|1||Jones1234
O|1|Jones1234||^^^ProtC|R|20101208184500
R|1|^^^ProtC|0.417 U/ml|U/ml||FR||F||||20101208190753|DYNEXRD-LT
P|2||Scott4567
O|1|Scott4567||^^^ProtC|R|20101208184500

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 Chapter 7: Transmission of Information to a Host System

R|1|^^^ProtC|161.537 U/ml|U/ml||FR||F||||20101208190753|DYNEXRD-LT
P|3||Federer2345
O|1|Federer2345||^^^ProtC|R|20101208184500
R|1|^^^ProtC|161.537 U/ml|U/ml||FR||F||||20101208190753|DYNEXRD-LT
P|4||Green6789
O|1|Green6789||^^^ProtC|R|20101208184500
R|1|^^^ProtC|161.537 U/ml|U/ml||FR||F||||20101208190753|DYNEXRD-LT

In the above example, there is no message terminator. The control and standard results will be
added at this point to the message and a terminator will end the entire message.

7.1 Control and Standard Transmission Format

The measured Control and Standard results are transmitted as if they were requested orders.
These results are appended to the regular sample results portion of the message. LIS-Link will
generate a “Laboratory Patient ID” and use it for the Control and Standard results. The
generated “Laboratory Patient ID” cannot be modified. The message terminator will be sent after
the Control and Standard results. The LIS Host must be configured to recognize these
unexpected “patients” as controls or standards and process them accordingly.
P|5||A1_S1_ProtC_PlateName_20101208190720
O|1|A1_S1_ProtC_ PlateName _20101208190720||^^^ProtC|R|20101208190725
R|1|^^^ProtC|0.001 U/ml|U/ml||FR||F||||20101208190753|DYNEXRD-LT
Figure 45: Controls and Standard Results Example

Table 15 describes the format of the generated Patient ID is:

Table 15: Patient ID Fields and Descriptions
Field Description Example
Patient Patient record identifier P
5
For example: This is the
Sequence Number Sequence number
fifth patient record in the
current data transmission.
Plate Well Location A1, A2, A3, ..., F12, G12, H12. A1
This is taken directly from the template definition
screen. For most controls and standards it will be a
Well Type S1
designation such as C1, NC1, PC2, CO1, S1, S2,
etc.
Assay Name Test or assay ID, as the Host knows it. ProtC
ID number/text unique to this plate. This is the
Plate ID plate name entered by the user at runtime during PlateName
the Load Wizard.
Date/time the assay completed, in the standard
Date/time 20101208190720
YYYYMMDDHHMMSS format.
For replicate Standards and Controls, as long as Average Replicates is selected in data
reduction output formats, the average value will be transmitted to the host. If Average
Replicates is not selected, then the value of the first replicate will be transmitted.

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 Chapter 7: Transmission of Information to a Host System

7.2 Example of Routine Data Exchanges

7.3 Outgoing Query to Host
H|\^&|||DX Computer Name||||||||1|20040520115138
Q|1|Scott 587492||||||||||O  Scanned Sample lDs.
Q|2|Jones 456391||||||||||O
Q|3|Lucci 581359||||||||||O
Q|4|Gomez 781264||||||||||O
Q|5|Stein 611284||||||||||O
Q|6|Lupe 461129||||||||||O
Q|7|Reginald 911274||||||||||O
Q|8|Smith 193460||||||||||O
L|1|N

7.4 Incoming Test Orders from Host

H|\^&|||LIS-Host Name||||||||1|20040520115138|
P|1||Scott587492||  SampleID from Field 4 of patient record
O|1|Scott587492||^^^RUBG
P|2||Jones456391||RJones
O|1|Jones456391||^^^RUBG  SampleID from Field 3 of Order record
P|3||Lucci581359||GLucci
O|1|Lucci581359||^^^RUBG  Assay Name from Field 5 of Order Record
O|2|Lucci581359||^^^CMVG

L|1|N

7.4.1 Outgoing Results from Host

H|\^&|||LIS-Host Name||||||||1|20040520115814
P|1|| Scott587492 SampleID
O|1| Scott587492||^^^RUBG|R|20040513071837 R|1|^^^RUBG|NEG|||FR||F||||20040520115814|DSX0055
P|2||Jones456391
O|1|Jones456391||^^^RUBG|R|20040520115142 Order
R|1|^^^RUBG|0.33457|OD||RW||F||||20040520115814|DSX0055
R|2|^^^RUBG|POS|||FR||F||||20040520115814|DSX0055
P|3||Lucci581359
O|1|Lucci581359||^^^CMVG|R|20040520115142
R|1|^^^RUBG|0.33457|OD||RW||F||||20040520115814|DSX0055
R|2|^^^RUBG|POS|||FR||F||||20040520115814|DSX0055 Result
R|3|CMVG|NEG| ||FR||F||||20040520115814|DSX0055
...
L|1|N

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 Chapter 7: Transmission of Information to a Host System

Figure 46: Examples of Result Display

Figure 47: LIS-Link Box

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 Chapter 7: Transmission of Information to a Host System

Click for additional configuration information.

Figure 48: Help Box

7.4.2 Host Message Framing

We receive a number of calls every year for help with a specific LIS-Link problem involving
“framing”. We felt a section in this guide mentioning this issue will help a number of customers.
Framing is configured in the laboratory host system software only.
This is a highly technical issue. For details, refer to Section 8.3.1 of LIS01-A2 for details.
Messages are sent in “frames”. Frames are numbered. The frame number is sent immediately
after the <STX> command that starts the frame transmission.
The frame number is a single digit ranging from 0 to 7. The first frame begins with 1 and this
frame number increments 1 with each new frame. After 7, the frame number rolls over to 0 and
continues to increment to 7 again.
Currently, frame numbers do not appear in the LogDebugActions.txt file that LIS-Link writes to.
To see frame numbers, one must look at the detailed host trace log file. The digit is inserted
immediately after the <STX> command. It is not separated from message data characters, so
one must understand the message structure to “see” it.
If customers do not set their systems to roll over the frame numbers correctly, frames can be
numbered with 8, 9, 10 and so on.

 Note: LIS-Link does not recognize frames with numbers higher than 7.
The customer may see LIS-Link checking off only the first part of the list of samples.

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 Chapter 7: Transmission of Information to a Host System

7.4.3 Order by Proxy

LIS-Link version 2.40 and above has been modified to support the external pipetting feature.
This version looks for a new OrderByProxy flag in the results file generated by DYNEX
instruments (DSX, DS2 and Agility) to distinguish between the external pipetting mode and the
normal pipetting mode of operation.
For externally pipetted plates, the LIS-Link software automatically sends the results that are
displayed in the user interface.

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 Appendix A: Acronyms

Acronyms
Acronym Definition
CD Compact Disk
CD-ROM Compact Disk Read Only Memory
CLSI Clinical and Laboratory Standards Institute
DVD Digital Video Disk
eBox Electronic Box
EC European Community
ELISA Enzyme-Linked Immunosorbent Assay
EU European Union
GB Gigabyte
GHz Gigahertz
GUI Graphical User Interface
IT Information Technology
LAN Local Area Network
LIMS Laboratory Information Management System
LIS Laboratory Information System
MB Megabyte
NCCLS National Committee for Clinical Laboratory Standards
OS Operating System
PC Personal Computer
RAM Random Access Memory
RS-232 Recommended Standard-232
SoC System-on-a-Chip
SVGA Super Video Graphics Array
TB Tuberculosis
TCP/IP Transmission Control Protocol/Internet Protocol
UI User Interface
USB Universal Serial Bus
WDDM Windows Display Driver Model
XML eXtensible Markup Language

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 Appendix A: Acronyms

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© 2023 DYNEX Technologies Inc. 54 Part No. 91001020

For more information on how DYNEX can help you achieve optimal
laboratory proficiency, contact your local DYNEX business partner.
For more information on how DYNEX can help you achieve optimal
CORPORATE HEADQUARTERS GLOBAL LOCATIONS
laboratory proficiency, contact your local DYNEX business partner.
DYNEX Technologies, Inc. DYNEX Technologies, Ltd.- Germany
14340 Sullyfield Circle Email: [email protected]
Chantilly, VA 20151
CORPORATE
Tel: HEADQUARTERS
+1.703.631.7800 DYNEX Technologies, Ltd. – United Kingdom
dynextechnologies.com Email: [email protected]
DYNEX Technologies, Inc.
DYNEX Technologies, Ltd. – China
Email: [email protected]

©2023 DYNEX Technologies, Inc. All Rights Reserved. | 91001020 | Item approved for Global Use.