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GeneXpert Dx 4.7b Software Release Notes

This document contains new information, known limitations, and clarifications not described in
the GeneXpert Dx System Operator Manual.

Cepheid recommends to always confirm that LIS uploaded results match GeneXpert test results
after any changes to the GeneXpert or Host system, including (but not limited to) changes to the
 GeneXpert software version
 GeneXpert Assay Definition version
 GeneXpert Host Communication Settings
 Host middleware software or configuration changes
 LIS software or configuration changes

1 Setup
1.1 If a new GeneXpert instrument is not appearing in the Check Status screen, check that
the instrument is properly connected as described in the installation instructions in the
GeneXpert Operator Manual. If connections are correct, the GeneXpert Dx software may
need to be restarted a second time to recognize the instrument.

2 Create Test
2.1 Do not scan a barcode into the Patient ID or Sample ID fields in the Create Test dialog
box if you have already typed in the field. Scanning a barcode after typing into the field
will cause invalid characters to be scanned. To update the Patient ID or Sample ID field,
close the Create Test dialog box, select Create Test again, and scan the ID barcode.
2.2 The host test code should not be disabled while there are pending test orders to test or
test results to upload that use the test code. If you need to disable a host test code with
pending orders, restart the software after the test code is re-enabled.
2.3 GX Dx 4.6 and higher does not support a combination of BA 4-Plex and BG Duplex

3 View Results
3.1 Re-test any test with a status of “Incomplete”. The status of each test is displayed on the
bottom left panel of the View Results screen.

4 Data Management
4.1 While tests are being deleted after archiving, there is no hourglass indicating that
deletion is in process. Do not archive additional tests until after the “Archive Successful”
dialog box appear, confirming successful deletion of the previous tests.

300-8397, Rev. N
Feb 2016
Cepheid Confidential
Page 2 of 3
GeneXpert Dx 4.7b Software Release Notes
5 Maintenance
5.1 Plunger Maintenance should not be performed while tests are in progress. If plunger
maintenance is started while tests are in progress and a module where plunger
maintenance is being performed (syringe rod lowered) becomes unavailable to complete
the maintenance (raise syringe rod), the GeneXpert Dx software must be restarted after
tests complete.
5.2 During plunger maintenance, if the module loses communication where the plunger
maintenance is being performed (syringe rod in the lowered position), and the module
becomes unavailable to complete the maintenance (will raise syringe rod), the GeneXpert
Dx software must be restarted to establish communication to the module in order to
complete plunger maintenance.

6 Host (LIS) Connectivity and Communication

6.1 No failure message is sent to the Host for test orders with missing or incorrect
 Host test order has long Sample ID (longer than 25 characters)
 Host test order has missing test code
 Host test order has missing Sample ID
6.2 If LIS sends a query to GeneXpert for test results using the ISID provided by
GeneXpert, for cases where the same Sample ID was used for multiple tests, the
response to the query may be missing some of the test results for that sample ID.
This is due to the way GeneXpert provides ISIDs to LIS.
 For ASTM protocol, only one ISID is uploaded from the GeneXpert for all
orders that have the same Sample ID.

 For HL7, unique ISIDs are uploaded from the GeneXpert for each order that
has the same Sample ID, but the response does not include sufficient
information to allow LIS to associate the unique ISID with a specific test
If test results are missing in response to LIS result query they may be uploaded directly
from GeneXpert.
6.3 Users running % ratio assays in French, Chinese and Japanese can view overall test
results, but optional records are not uploaded during LIS transmission.

300-8397, Rev. N
Feb 2016
Cepheid Confidential
Page 3 of 3
GeneXpert Dx 4.7b Software Release Notes
7 Localization
7.1 When the GeneXpert software is run in the Russian configuration, file selection dialogs
display some text in English instead of being translated into Russian. The affected
dialogs are the Save dialog during Archive Test, Open dialog during Retrieve Test,
Database Backup dialog, and Select File dialog during Database Restore.

The missing translations are:

“Look In” - "Найти в"

“File Name” - "Имя файла"
“Files of Type” - "Тип файлов"
“Cancel” - "Отменить"
“Open” -"Открыть"
7.2 If changing the Report folder in System Configuration from its default, do not include
Chinese or Russian characters in the folder path. Including these characters will prevent
the “Print Test Report At End of Test” feature from printing.

7.3 For Japanese operating system users using the Hiragana keyboard, the special characters
/,\ and * are not supported. Entering these characters will clear previously entered valid
characters in that field. Pressing the Backspace key will restore the cleared text and
allow user to continue entering valid characters.

8 Assay Import
8.1 If the “Invalid file selected” error message is encountered when attempting to import a
higher version of an existing assay, the next restart of the GX Dx software will return
“Database integrity issue found in database” error message. Selecting Proceed will repair
database integrity issue. After database issue is repaired, selecting OK on confirmation
message will exit the GX Dx software. A higher version of an existing assay can then be
imported after re-starting software.

300-8397, Rev. N
Feb 2016
Cepheid Confidential