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SARS-CoV-2

Test Information

1. What sample types and collection devices can be used with Xpert® Xpress SARS CoV-2/FLU/RSV?

Sample Types:
GeneXpert Dx and Infinity Systems: Nasopharyngeal swab, nasal swab and nasal/wash aspirate specimens in 3mL of UTM/VTM or saline. 
GeneXpert Xpress systems (Hub and Tablet): Nasopharyngeal swab and nasal swab specimens in 3mL of UTM/VTM or saline. 
 

2. What are my options for Viral Transport Media for Xpert Xpress SARS-CoV-2/FLU/RSV?

Viral transport media is available from several commercial vendors who may use the terminology VTM (Viral Transport Medium).  Alternate transport media, not identified in the package inserts (302-4421 Xpert Xpress SARS-CoV-2 Flu RSV EUA English Package Insert, 302-5159 Xpert Xpress SARS-CoV-2 Flu RSV CE IVD English Package Insert), should not be used with Xpert® Xpress SARS-CoV-2/Flu/RSV.  

Due to the limited supply of commercial collection devices and transport media, the FDA has posted some information on their website including the “COVID-19 Transport Media Policy” and “Testing Supply Substitution Strategies” slides, which can be accessed on their “FAQs on Testing for SARS-CoV-2” webpage: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#testingsupply. For additional questions, please contact Cepheid’s Technical Support team.

All inquiries about off-label use, including those pertaining to transport media/transport media containing inactivation reagents, need to be addressed to Medical Affairs for support (MedSci.Affairs@cepheid.com).

3. What external quality control (QC) material options are available for SARS CoV-2/FLU/RSV?

The listed external controls are Zeptometrix SARS-COV2/FLU/RSV Positive Control (PN: NATFRC-6C) and Negative Control (PN: NATCV9-6C). These are described in the “materials available but not provided” section of the Package Insert. Please consult with Cepheid’s Technical Support team to inquire about additional commercial options. Customers may also elect to use other commercial sources or previous patient specimens.

4. What are the requirements for verification and what guidelines do you have for transitioning from my current Xpert Xpress SARS-CoV-2 and/or Xpert Xpress Flu/RSV tests to the Xpert Xpress SARS-CoV-2/FLU/RSV test?

Before going live with a new test, a verification study may be necessary.  A verification guide that describes the preparation of contrived positive specimens (prepared by spiking commercial reference material into negative specimens) is available for download (see above).  Alternatively, customers can also use previously tested patient specimens for a verification study. Please follow your laboratory and regulatory requirements when instituting a new test in your laboratory. 

5. Why isn’t there a CD with the ADF and Package Insert in my Xpert Xpress SARS-CoV-2/FLU/RSV test kit?

In an effort to reduce our environmental footprint, Cepheid is moving towards CD-less products.  The Package Inserts, ADFs and ADF import instructions for the SARS-COV-2/FLU/RSV test are available for download on this website (see above).  For customers who prefer to obtain the ADFs on a CD, please fill out the CD ADF request using one of the following links. USA requests: CD ADF REQUEST FORM; International Requests: CD ADF REQUEST FORM

CE-IVD In Vitro Diagnostic Medical Device. Not available in all countries.These tests have been authorized by FDA under an EUA for use by authorized laboratories;
Xpert Xpress SARS-CoV-2  has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens;
Xpert Xpress SARS-CoV-2/Flu/RSV has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, influenza B virus, and RSV and not for any other viruses or pathogens; and
These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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