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SARS-CoV-2

Test Information
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Introducing Xpert® Xpress CoV-2/Flu/RSV plus* and Xpert® Xpress CoV-2 plus*

Enhanced gene coverage, plus the option of multiplex viral detection. When you need to know if it’s the flu, COVID-19, or RSV, choose a testing duo that delivers more. With our growing respiratory portfolio, Cepheid offers fast and accurate options to deliver more than results. Whatever your testing needs, Cepheid has you covered.

Coverage, plus
Accuracy, plus
Peace of mind

That’s the PCRplus advantage. From Cepheid

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* 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 CoV-2 plus has been authorized only for the detection of nucleic acids from SARS-CoV-2, and 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 acids from SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (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.

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1. What is Cepheid doing to enable detection of variants of SARS-CoV-2?

Cepheid has launched both the Xpert® Xpress CoV-2/Flu/RSV plus and Xpert® Xpress CoV-2 plus tests that provide rapid, accurate detection, 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.

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

Cepheid’s tests are well suited for pandemic response. From the time a sample (such as a nasopharyngeal swab) is taken, a result can be obtained in less than an hour on our automated systems. 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.  Xpert® Xpress CoV-2/Flu/RSV plus can report positives for SARS-CoV-2 in as little as 25 minutes* and Xpert® Xpress CoV-2 plus tests can report a positive result as soon as 20 minutes.^

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 are supported?

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

5. Which coronaviruses are detected by Cepheid’s SARS-CoV-2 tests?

The tests are designed to detect SARS-CoV-2, the virus that causes COVID-19. Xpert Xpress CoV-2/Flu/RSV plus and Xpert Xpress CoV-2 plus target the E, N2, and RdRP genes for robust detection of SARS-CoV-2.

6. Which specimen types are accepted?

Xpert Xpress CoV-2/Flu/RSV plus and Xpert Xpress CoV-2 plus support a variety of sample types including nasopharyngeal and anterior nasal swabs in UTM/VTM, saline, or 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 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 anterior nasal swabs in UTM/VTM, saline, and eNAT, but do not support nasal wash/aspirate samples.  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.

For use under an Emergency Use Authorization in the United States.
* With early assay termination for positives when running SARS-CoV-2 only. Full run time is 36 min.
With early assay termination for positives. Full run time is 30 min.
See package insert for details; sample types may vary by system and regulatory status.

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