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SARS-CoV-2

Test Information

New Test Designed to Be More Robust Against Mutations

Announcing Xpert® Xpress CoV-2/Flu/RSV plus

Introducing our next-generation Xpert Xpress CoV-2/Flu/ RSV plus test, designed to include a more robust three-gene detection of SARS-CoV-2 to enable better virus variant detection and further mitigate the possible effects of viral mutations.

Enter the upcoming respiratory virus season with the confidence of a single test to detect and differentiate SARS-CoV-2, Flu A, Flu B, and RSV. The test can provide rapid on-demand detection of SARS-CoV-2 as soon as 25 minutes for positive results* and provide results for all four pathogens in just 36 minutes with less than a minute of hands-on time.

For use under Emergency Use Authorization only in the United States.
*With early assay termination for positives when running SARS-CoV-2 only. Full run time is 36 min.

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1. What is Cepheid doing to aid in the detection of viral mutation?

For the upcoming respiratory season in the Northern Hemisphere, Cepheid has launched a test that provides rapid, accurate detection and differentiation of SARS-CoV-2, Flu A, Flu B, and RSV in as little as 36 minutes, while offering three gene targets for SARS-CoV-2 to enable detection of current and future variants of the SARS-CoV-2 virus. The test has been designed for broader coverage to mitigate the possible effects of viral genetic drift. Early assay termination available when running SARS-CoV-2 only with positive results as soon as 25 min.

2. How fast are Cepheid’s SARS-CoV-2 tests?

Cepheid’s tests are well suited for pandemic response. Many of our GeneXpert® Systems are in hospital labs and other near-patient settings. From the time a sample (such as a nasopharyngeal swab) is taken, a result can be obtained in less than an hour. We call this “sample to answer” and the samples can be loaded as they are received for true on-demand testing. It takes less than a minute to prepare the cartridge with the patient sample. The newest Xpert Xpress CoV-2/Flu/RSV plus test can report a positive result for SARS-CoV-2 as soon as 25 minutes* after a test cartridge is loaded onto the system.

3. How do I get a GeneXpert System at my facility?

Click the green Request Information button at the top of this page to be connected with your local Cepheid Sales Representative.

4. Which GeneXpert Systems will be supported?

All of Cepheid’s SARS-CoV-2 tests, including Xpert Xpress CoV-2/Flu/RSV plus, can be run on GeneXpert II, IV, XVI, Infinity 48, Infinity 80, and Xpress Systems (hub and tablet).

5. Which strains of coronavirus are detected by Cepheid’s SARS-CoV-2 tests?

The tests are designed to detect the SARS-CoV-2 strain of the coronavirus, the virus that causes COVID-19. Xpert Xpress CoV-2/Flu/RSV plus uses the E, N2, and RdRP genes to detect SARS-CoV-2, and also detects and differentiates Flu A, Flu B, and RSV.

6. Which specimen types are accepted?

Should read:

 

Xpert Xpress CoV-2/Flu/RSV plus supports a variety of sample types including nasopharyngeal and nasal swabs in UTM/VTM and saline.  Nasopharyngeal and nasal swab samples can be used with eNAT.  Additional information, including sample types for Cepheid’s other SARS-CoV-2 tests, can be found on the product resource page at www.cepheid.com/coronavirus-resources and in the package inserts.^

7. Are Cepheid’s SARS-CoV-2 tests CLIA waived?

Cepheid’s SARS-CoV-2 tests are authorized to be run on the GeneXpert Xpress System in point-of-care settings. As such, the FDA deems these to be CLIA waived tests that can be used in settings operating under a CLIA Certificate of Waiver or Certificate of Compliance. These tests are also FDA authorized to be run on GeneXpert and Infinity Systems in laboratories certified under CLIA to perform high- and moderate-complexity tests. GeneXpert Xpress Systems support nasopharyngeal and nasal swabs in UTM/VTM, saline and eNAT.  Nasal wash/aspirate sample types are NOT supported.  Please refer to the package inserts for complete details; an explanation from the FDA can be found in their FAQ section at  https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2.

Learn About Cepheid GeneXpert® Systems

GeneXpert® Infinity Systems

“Load and go” technology delivers total automation for up to 2,000 tests a day.

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GeneXpert® Systems

Available in 2, 4 or 16-module configurations that all use the same cartridge technology.
 

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* For positives when running SARS-CoV-2 only on Xpert Xpress CoV-2/Flu/RSV plus; otherwise, the test will have a runtime of approximately 36 minutes.
^See package insert for details; sample types may vary by system and regulatory status.
These tests have not been FDA cleared or approved.
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 CoV-2/Flu/RSV plus 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.
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.

Emergency Use Authorization of Medical Products and Related Authorities.

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