Cepheid

GeneXpert Express System

Xpress System (Tablet Configuration) Quick Reference Guide Rev B April 2020

Quick Reference Guide

2 Pages

Quick Reference Instructions for Xpert® Xpress SARS-CoV-2 and GeneXpert Xpress System (Tablet Configuration) For use under the Emergency Use Authorization (EUA) only. The user should be trained in the procedure. Wear the appropriate protective attire for your safety when handling patient samples. Clean testing surfaces according to your institution’s policy. This test is only for nasopharyngeal swab, nasal swab and mid-turbinate swab specimens. Read the complete Quick Reference Instructions before performing the test. For assistance, call Cepheid Technical Support at (888) 838-3222.  I Storage and Handling and Warnings Storage and Handling  • •  Wear gloves. Change gloves between processing each sample. Store the Xpert Xpress SARS-CoV-2 cartridges at 2-28°C.  Warnings • • • • • • •  DO NOT use a cartridge that is wet or has leaked. DO NOT use a cartridge that has been dropped. DO NOT open a cartridge lid until you are ready to perform testing. DO NOT shake or tilt the cartridge after adding the sample. DO NOT reuse disposable pipettes or cartridges. DO NOT turn off or unplug the instrument while a test is in progress as this will stop the test. DO NOT use a cartridge that has a missing or damaged reaction tube.  Refer to Package Insert for Warnings and Precautions, Specimen Collection and Handling, and Quality Control Testing.  II How to Start the Software 1 Start Software.  2 Enter Password. 3 Touch Begin Button. a. Put on a pair of clean gloves. a. Touch Password to display the a. Press the TOUCH HERE TO b. Turn on the GeneXpert Xpress instrument keyboard. BEGIN button. (GeneXpert Xpress II or GeneXpert b. Enter your password. b. If applicable, enter your user Xpress IV). c. Touch the arrow button at the name and password. c. Turn on the computer. right of the password entry area. • Windows 7: The Windows 7 account screen appears. Touch the Cepheid-Admin icon to continue. • Windows 10: The Windows lock screen appears. Swipe up to continue.  4 HOME Screen Displayed.  The Home screen will be displayed with the VIEW PREVIOUS TESTS button appearing initially. The RUN NEW TEST button will appear on the Home screen within 1 minute. (GeneXpert Xpress IV screen shown below).  III How to Test a Patient Specimen Before You Begin: • • •  Refer to the package insert for more information. Read through this entire Quick Reference Instructions before beginning a test. Instructions on how to prepare the specimen and the cartridge (presented below) are also shown in a video within the software.  • •  Start the test within 30 minutes of adding the specimen to the cartridge. The recommended environmental operating conditions for Xpert Xpress SARSCoV-2 are 15-30°C, 20-80% relative humidity.  1 Start a Test.  2 Enter & Confirm Patient/Sample ID.  3 Scan and Confirm Cartridge.  4 Watch Video. Mix Specimen.  5 Fill Pipette with Sample.  6 Transfer Sample to Cartridge.  7 Load Cartridge.  8 Remove Cartridge. View Results.  a. Touch RUN NEW TEST on the Home screen (GeneXpert Xpress IV screen shown below). b. Check that the specimen tube cap is closed.  a. Remove the pipette from the wrapper. b. Squeeze the top bulb of the pipette completely and place the pipette tip in the specimen transport tube. c. Release the top bulb of the pipette to fill the pipette with sample from the patient specimen tube.  a. If there is a Patient/Sample ID barcode, touch the YES button then scan the Patient/ Sample ID with the scanner. b. If there is no Patient/Sample ID barcode, touch the NO button then manually enter the Patient/Sample ID and touch the OK button. c. Touch the YES button to confirm that the Patient/Sample ID is correct.  a. Squeeze the top bulb of the pipette completely again to empty the contents of the pipette into the large cartridge opening (Sample Chamber). Sample Chamber (Large Opening)  b. Close the cartridge lid. Dispose of the used pipette in an appropriate waste container.  9 How To Start a New Test. a. Put on a new pair of gloves if performing a new test. b. Touch the HOME button to go to the Home Screen. c. Start a new test following the steps in this section starting with Step 1, Start a Test, or for starting a test while a test is running or a new test with another user, see Step 10.  2020 Cepheid  a. Remove a cartridge and a transfer pipette from the cartridge kit box. b. Scan the barcode on the cartridge with the scanner. Touch YES if the displayed information is correct. c. If applicable, enter your user name and password.  a. Open the instrument door with the blinking green light. b. Load the cartridge with barcode facing the operator on the cartridge bay platform.  c. Close the door until it clicks.  a. Watch video before performing Steps 5, 6, and 7. The video will repeat. Touch the SKIP VIDEO AND CONTINUE button to exit video. b. Mix specimen by rapidly inverting the specimen transport tube 5 times. Open the cap on the specimen transport tube. c. Open the cartridge lid.  a. When the test is completed, the door will unlock and the Remove Cartridge screen will be displayed. b. Follow the on-screen instructions to remove the cartridge. Touch CONTINUE to view the result of the test.  c. To print the results, touch the PRINT RESULT button. d. Dispose of the cartridge and gloves according to your institution’s policy.  10 Starting Another Test While a Test is Running. a. Put on a new pair of gloves if performing a new test. b. Touch the HOME button to go to the Home Screen. c. Touch the SIGN OUT button to log out previous user, if applicable. d. Start a new test following the steps in this section starting with Step 1, Start a Test.  For IVD In Vitro Diagnostic Use Only  302-3749 Rev. B April 2020
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