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SARS-CoV-2

Test Information

Introducing a Single Test for SARS-CoV-2,
Flu A, Flu B, and RSV

Fast, accurate, and actionable test results for this respiratory season

Learn About SARS-CoV-2 Testing

Featured Webinar: Antimicrobial Resistance and the 1-2 Punch of COVID-19

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FAQs

1. What are SARS-CoV-2 and COVID-19?

SARS-CoV-2 is the name of the novel coronavirus strain, short for Severe Acute Respiratory Syndrome Coronavirus 2, responsible for the current global pandemic. SARS-CoV-2 causes the disease named COVID-19.

2. What is Cepheid doing to aid in the detection of SARS-CoV-2?

Cepheid is responding to the global need with rapid and easy-to-use tests that enable healthcare providers to obtain a result within an hour of obtaining a patient sample. Xpert Xpress SARS-CoV-2 runs on our GeneXpert® system, which has over 25,000 placements worldwide, running a menu of over 20 US-IVD and CE-IVD tests. For the upcoming respiratory season in the Northern Hemisphere, Cepheid has launched a single test to detect SARS-CoV-2, Flu A, Flu B, and RSV.

3. 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 SARS-CoV-2 test, Xpert Xpress SARS-CoV-2/Flu/RSV, can report a positive result for SARS-CoV-2 in as soon as 25 minutes* after a test cartridge is loaded onto the system.

4. What is Cepheid’s regulatory plan?

Xpert Xpress SARS-CoV-2 received US FDA Emergency Use Authorization in March and CE-IVD mark in May 2020. Cepheid is pursuing similar regulatory pathways for Xpert Xpress SARS-CoV-2/Flu/RSV and is excited to announce US FDA Emergency Use Authorization on September XX 2020. Cepheid is working closely with other regulatory agencies to attain the relevant clearances to ensure that we deliver these tests globally to those countries most in need.

5. How do I get one of Cepheid’s SARS-CoV-2 tests?

Hospitals and labs currently using a GeneXpert System will be able to run the tests. It’s up to the healthcare professionals at those facilities to determine who meets the criteria for being tested.

6. 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.

7. What materials are needed to run a test?

The test cartridge is a complete solution containing all the necessary reagents. A patient sample is loaded into the cartridge and a GeneXpert System is required to run the test. This is different from some other test kits on the market that may require additional reagents such as extraction materials.

8. Which GeneXpert Systems will be supported?

Xpert Xpress SARS-CoV-2 and Xpert Xpress SARS-CoV-2/Flu/RSV can be run on GeneXpert II, IV, XVI, Infinity 48, Infinity 80, and Xpress Systems.

9. Which strains of coronavirus are detected by Xpert Xpress SARS-CoV-2 and Xpert Xpress SARS-CoV-2/Flu/RSV?

The tests are designed to detect the SARS-CoV-2 strain of the coronavirus family by detecting the E and N2 genes. Xpert Xpress SARS-CoV-2/Flu/RSV also detects and differentiates Flu A, Flu B, and RSV.

10. Which specimen types are accepted?

Xpert Xpress SARS-CoV-2 and Xpert Xpress SARS-CoV-2/Flu/RSV support a variety of sample types including nasopharyngeal and nasal swabs in UTM/VTM. Additional information can be found on the product resource page www.cepheid.com/coronavirus-resources and in the package inserts.#

11. Are Xpert Xpress SARS-CoV-2 and Xpert Xpress SARS-CoV-2/Flu/RSV CLIA waived?

Xpert Xpress SARS-CoV-2 and Xpert Xpress SARS-CoV-2/Flu/RSV 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. Please refer to the package inserts for complete details; an explanation from the FDA can be found in their FAQ section https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2.

13. How can I get more information?

This webpage will be updated regularly with additional information as it becomes available. For questions please click the green Request Information button at the top of this page or the Access Product Resources button for more technical resources.

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 1, 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 SARS-CoV-2/Flu/RSV; otherwise, the test will have a runtime of approximately 36 minutes.
For positives only; reporting of negatives in approximately 45 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 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.

Emergency Use Authorization of Medical Products and Related Authorities.

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