Quick Reference

Instructions
GeneXpert® Edge System 

-Read the Package Insert for complete assay information.

-Refer to the GeneXpert Edge System User’s Guide
for detailed information about the instrument.
-For assistance, contact Cepheid Technical Support (see page 4).
-DO NOT start a test without sufficient battery charge. Refer to the
battery label to ensure adequate charge before starting a test.
Starting the Software and Instrument
1. Put on a clean pair of gloves.
2. Turn on the GeneXpert Edge Instrument.
3. Turn on the tablet computer. The Windows® screen will display.
4. Swipe up on the lock screen.
5. The Windows login screen will display. Touch the
Password field to display the keyboard. Enter the password.
6. Touch the arrow button at the right of the password
entry area to log in.
7. The Welcome Screen appears after the software initializes. Touch
the TOUCH HERE TO BEGIN button.
8. The VIEW PREVIOUS TESTS button will display. The RUN NEW
TEST button will appear on the Home screen within 3 minutes.

301-3202 Rev. B IVD

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Starting a Test with a Patient Specimen
Before you begin
• Read through this entire guide before beginning a test.
• Instructions on how to prepare the specimen and the cartridge are
shown in a video within the software for some assays. Please refer
to the assay package insert for complete information.
• If using the battery to run the test, verify there is adequate charge.
1. Touch RUN NEW TEST on the Home screen.
2. Remove a cartridge and a transfer pipette (if provided) from the
cartridge kit box.
3. Check that the specimen cap is closed. Scan the Sample/Patient ID
with the scanner or manually enter the Sample/Patient ID.
4. Touch YES if the displayed information is correct.
5. Scan the barcode on the cartridge.
NOTE: If the barcode on the cartridge does not scan or scanning the barcode results
in an error message stating the cartridge is expired, then repeat the test with
a new cartridge.
NOTE: If you have scanned the cartridge barcode in the Edge software and a
message indicating the assay definition file is not available appears, contact
Cepheid Technical Support.
NOTE: Not all Xpert tests are compatible with the Edge System.
6. Confirm the correct assay name from the Confirm Test screen by
touching the assay name.

7. Touch YES if the displayed information is correct.

8. Confirm the name on the cartridge matches the one shown on
screen.
9. Open the cartridge lid by lifting the front of the cartridge lid.
10. Remove the pipette from the wrapper by opening the end
next to the top bulb.
11. Depending on the assay, instructions for preparing the cartridge for
processing may be displayed on a video on the tablet computer.
See the Package Insert for complete instructions.

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12. Load the cartridge by gently placing
it onto the black loading platform
with the barcode facing the operator.
13. Close the door firmly until it latched. The green
light will stop blinking and the test will start.
14. When the test is complete, the green light will
turn off and the door will unlock.
15. When the Remove Cartridge screen is displayed, follow the
on-screen instructions to remove the cartridge.
16. Dispose of the used cartridge and gloves in an appropriate waste
container according to your institution’s standard practices.
17. Touch CONTINUE to view the result of the test.
18. Touch HOME to go back to the Home screen.
19. Check battery level to see if charging is required before the next test.
NOTE: To access the Remove Cartridge screen from the HOME screen after a test is
complete, touch the Test complete, touch to continue icon.
NOTE: If you encounter an instrument error, touch CLEAR ERROR and follow the
on-screen instructions to remove the cartridge.
NOTE: Refer to the Package Insert and GeneXpert Edge System User’s
Guide for information on reviewing past results or printing results.

Running Quality Control Samples

1. Put on a clean pair of gloves. Have a new cartridge, a quality control
sample, and a transfer pipette ready.
2. Touch RUN NEW TEST on the HOME screen. Touch NO for the
sample barcode on the Sample ID screen.
3. Touch the Sample ID field to display the keyboard. Type negative
control for the Negative Control or positive control for the Positive
Control. Touch OK.
4. Scan the barcode on the cartridge.
5. Select the correct assay touching the assay name from the Select
Assay menu, if applicable. (See Starting a Test with a Patient
Specimen, step 6).
Follow the remaining steps in Starting a Test with A Patient Speci-
men.
NOTE: If you encounter an instrument error, touch CLEAR ERROR and follow
the on-screen instruction. When the HOME screen appears, test a new
quality control sample using a new cartridge.
NOTE: If an unexpected result occurs, test a new quality control sample using a new
cartridge. If an unexpected result occurs upon retest, contact Cepheid
Technical Support.

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Possible Results
NOTE: Refer to the Package Insert for individual test results.
Result Interpretation
<Target> DETECTED Target is detected.

<Target> NOT DETECTED Target is not detected.

The errors below replace the errors shown in the Package Insert.
Result Interpretation
If result is “INSTRUMENT ERROR”,
touch CLEAR ERROR and follow the
INSTRUMENT ERROR on-screen instructions. When the Home
screen appears, repeat the test using a
new cartridge.
If result is “NO RESULT - REPEAT
TEST”, retest with a new cartridge.
NO RESULT-REPEAT
If retest is “NO RESULT - REPEAT
TEST
TEST”, call for assistance.

Technical Support
Region Telephone Email
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+ 1800 130 821
Australia and New Zealand techsupportANZ@cepheid.com
+ 0800 001 028
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China + 86 021 5406 5387 techsupportchina@cepheid.com
France + 33 563 825 319 support@cepheideurope.com
Germany + 49 69 710 480 480 support@cepheideurope.com
India, Bangladesh, Bhutan, Nepal,
+ 91 11 48353010 techsupportindia@cepheid.com
and Sri Lanka
Italy + 39 800 902 567 support@cepheideurope.com
South Africa + 27 861 22 76 35 support@cepheideurope.com
United Kingdom + 44 3303 332 533 support@cepheideurope.com
Other European, Middle East, and + 33 563 825 319
support@cepheideurope.com
African countries + 971 4 253 3218
Other Countries + 1 408 400 8495 techsupport@cepheid.com

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