FilmArray® Link Respiratory Panel

v1.7 Electronic Report Module TECHNICAL

FilmArray Link Overview
::: NOTE
The FilmArray Link Software and FilmArray Link Respiratory Panel (RP) v1.7
Electronic Report Module (referred to as the RP Electronic Report Module
throughout this document) facilitate the transfer of RP v1.7 test results from a
FilmArray system to a laboratory information system (LIS).
The software functions as follows:

• The FilmArray Link Software retrieves RP v1.7 test result data from a
configured FilmArray database.

• The data is sent to the RP Electronic Report Module, where the data is
formatted into an XML file (an electronic report).

• The FilmArray Link Software then sends the electronic report to the
bioMérieux Communication Interface (BCI) Link software.

• BCI Link transfers the electronic report to the LIS.

NOTE: The RP Electronic Report Module is compatible with the FilmArray Link
Software v2.0 (FilmArray 2.0 system) and the FilmArray Link Software v3.0
(FilmArray Torch system). “FilmArray Link Software” and “FilmArray system” are
used throughout this document to refer to both versions of the software and
system.

Purpose of the Document

The purpose of this document is to provide instructions for installing the RP
Electronic Report Module on a FilmArray system. This document also describes
how RP v1.7 test results are reported. The reporting information can be used to
map the RP v1.7 test results from an electronic report to an LIS.

Installing the RP Electronic Report Module

The FilmArray Link Software must be installed on the FilmArray system before
installing the RP Electronic Report Module. The RP Electronic Report Module will
only process RP v1.7 test results.
Before installing:
1. Download the software or order the software from BioFire Diagnostics
(provided on a CD and a USB drive).

• To download the software, visit the BioFire E-Document Center

(https://www.online-ifu.com/). The KEY-CODE is ITILIS48.
NOTE: A high-speed Internet connection is recommended for
downloading the installation file.
NOTE: Save the installation file to the root directory on a removable
drive.
TECHNICAL NOTE
BioFire Diagnostics, LLC
1|Page www.BioFireDX.com
FLM2-PRT-0229-02
 • To order the software on CD and USB drive, contact BioFire
Diagnostics Customer Support. Refer to the contact information at
the end of this document.
2. Refer to the appropriate instructions below to install the software on a
FilmArray 2.0 or a FilmArray Torch system. TECHNICAL
FilmArray 2.0 System ::: NOTE
To install the RP Electronic Report Module on a FilmArray 2.0 system computer:
1. Insert the CD or the removable drive containing the installation file into
the computer.
2. Launch the FilmArray Software v2.0 from the shortcut on the desktop.

3. Click on the FilmArray Link tab.

TECHNICAL NOTE
BioFire Diagnostics, LLC
2|Page www.BioFireDX.com
FLM2-PRT-0229-02
 4. Click the Install Module… button in the Electronic Report Module
Management section of the tab.

TECHNICAL
::: NOTE

5. Navigate to the installation file and double-click on the file

BioFire.FilmArray.FALink.ElectronicReport.RespiratoryPanel-1.7.dll.

TECHNICAL NOTE
BioFire Diagnostics, LLC
3|Page www.BioFireDX.com
FLM2-PRT-0229-02
 6. When the software has been successfully installed, the module name
and version are displayed in the Electronic Report Module Management
section of the FilmArray Link tab and the corresponding Is Active box is
checked.
TECHNICAL
::: NOTE

7. Remove the CD or the removable drive from the computer.

FilmArray Torch System

To install the RP Electronic Report Module on a FilmArray Torch system base:
1. Insert the removable drive containing the installation file into the system
base.
2. Select the FilmArray Link option on the Settings screen.

TECHNICAL NOTE
BioFire Diagnostics, LLC
4|Page www.BioFireDX.com
FLM2-PRT-0229-02
 3. Select Options on the FilmArray Link screen and then select the
Electronic Report Modules option.

TECHNICAL
::: NOTE

TECHNICAL NOTE
BioFire Diagnostics, LLC
5|Page www.BioFireDX.com
FLM2-PRT-0229-02
 4. Select the Install Module option on the Electronic Report Modules
screen.

TECHNICAL
::: NOTE

TECHNICAL NOTE
BioFire Diagnostics, LLC
6|Page www.BioFireDX.com
FLM2-PRT-0229-02
 5. Select the Install option associated with the RP v1.7 Electronic Report
Module (version 1.7.1.1).
NOTE: The software will only display installation files available in the root

TECHNICAL
directory of the connected removable drive.
A list of installed modules will be displayed once the installation is
complete.
::: NOTE

6. Remove the removable drive from the system base.

Reporting the FilmArray RP Targets and Results in the Electronic

Report
The RP Electronic Report Module formats RP v1.7 test results into electronic
reports. Each electronic report contains information from a single FilmArray test.
The report includes the names of the targets on RP v1.7, as well as the
corresponding target codes and test results.
TECHNICAL NOTE
BioFire Diagnostics, LLC
7|Page www.BioFireDX.com
FLM2-PRT-0229-02
Table 1 shows the reported names, result codes, and all possible results for each
RP v1.7 target.
As indicated in Table 1, there are some RP targets (i.e., Influenza A and its

TECHNICAL
subtypes) that are not always reported in the electronic report. Table 2 provides
more information on the conditional reporting of Influenza A and its subtypes.

Table 1: RP Test Result Reporting ::: NOTE

Note: An asterisk (*) in the Possible Result column indicates that the result is always reported in the electronic
report, regardless of the result.

Note: Influenza A, Influenza A (no subtype detected), Influenza A H1, Influenza A H1-2009, and Influenza A H3
are conditionally reported in the electronic report. It is possible that two Influenza A subtypes (i.e., H1, H1-2009,
and H3) may be reported in the electronic report for a single FilmArray test, where both are Detected or both are
Equivocal; otherwise, only one of the Influenza A targets will be reported. Note that the two Influenza A subtypes
H1 and H1-2009 are not reported simultaneously.

Note: When Influenza A (no subtype detected) is initially reported as Detected, the sample should be retested. If
the retest provides a different result, test the sample a third time to ensure the accuracy of the result. If the retest
provides the same result, then the function of the RP pouches should be verified by testing with appropriate
external control materials, and a negative control should also be run to test for PCR-product contamination. If the
FilmArray RP accurately identifies the external and negative controls, contact the appropriate public health
authorities for confirmatory testing.

TECHNICAL NOTE
BioFire Diagnostics, LLC
8|Page www.BioFireDX.com
FLM2-PRT-0229-02
 Table 2: Influenza A Conditional Reporting

TECHNICAL
::: NOTE

Note: The result codes in the electronic report for the possible test results are DETECT, NOT_DETECT, and
EQUIVOC.

Technical Support Contact Information

BioFire Diagnostics is dedicated to providing you with the best customer support
available. If you have any questions or concerns, please contact the FilmArray
Technical Support team for assistance.

BioFire Technical Support

Email: [email protected]
Phone: +1-801-736-6354, select Option 5

TECHNICAL NOTE
BioFire Diagnostics, LLC
9|Page www.BioFireDX.com
FLM2-PRT-0229-02