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SARS-CoV-2 Test Information

Xpert® Xpress SARS-CoV-2

A rapid, near-patient test for the detection of the 2019 novel coronavirus that causes COVID-19

Cepheid has developed an automated molecular test for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19. The test leverages the design principles of our current Xpert® Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted. The test can provide rapid detection of the current pandemic coronavirus SARS-CoV-2 in as soon as 30 minutes for positive results* with less than a minute of hands on time to prepare the sample. 

Xpert® Xpress SARS-CoV-2 can be utilized in multiple settings where actionable test results are needed to make informed treatment decisions quickly. The test delivers point-of-care results with the same level of performance seen in reference labs. The test is designed for use on Cepheid’s GeneXpert® Systems, which have a worldwide footprint of more than 25,000 instruments.

For use under Emergency Use Authorization only in the United States. CE-IVD In Vitro Diagnostic Medical Device. Not available in all countries.

Product Resources

Download Package Inserts

Additional Product Information & Resources

Quick Reference Instructions, Safety Datasheets, Fact Sheets,
Test Verification Protocal and Reimbursement Information

Cepheid Announces Development of Four-in-One Combination Test for SARS-CoV-2, Flu A, Flu B and RSV ^

The Xpert® Xpress SARS-CoV-2/Flu/RSV four-in-one testƚ is expected to deliver qualitative detection of SARS-CoV-2, Flu A, Flu B and RSV from a single patient sample. 

View Press Release

Learn About SARS-CoV-2 Testing

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 25,000 placements worldwide, running a menu of over 20 US-IVD and CE-IVD tests. Xpert Xpress SARS-CoV-2, a test that detects the SARS-CoV-2 virus, became available in March 2020. Cepheid has since announced the development of a second test which is expected to detect SARS-CoV-2, Flu A, Flu B, and RSV.^

3. How fast is the Xpert Xpress SARS-CoV-2 test?

The test is 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 and the GeneXpert can report a positive result in as soon as 30 minutes* after a test cartridge is loaded onto the system.

4. What is Cepheid’s regulatory plan?

Cepheid utilized the US FDA Emergency Use Authorization regulatory pathway and received authorization for Xpert Xpress SARS-CoV-2 on March 20, 2020. Additionally, Cepheid received CE-IVD mark on May 8, 2020. Cepheid is working closely with other regulatory agencies to attain the relevant clearances to ensure we deliver the test globally to those countries most in need. Cepheid will be pursing similar regulatory pathways for Xpert Xpress SARS-CoV-2/Flu/RSV.

5. When do you expect the Xpert Xpress SARS-CoV-2/Flu/RSV test to be available?

We expect Xpert Xpress SARS-CoV-2/Flu/RSV to be available in advance of the 2020-2021 Northern Hemisphere respiratory season. Cepheid will work closely with global regulatory agencies to ensure we can deliver the test globally, as quickly as possible.

6. How do I get an Xpert Xpress SARS-CoV-2 test?

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.

7. 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.

8. 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 which may require additional reagents such as extraction materials.

9. Which GeneXpert Systems will be supported?

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

10. What strains of coronavirus are detected by Xpert Xpress SARS-CoV-2?

The test is designed to detect only SARS-CoV-2.

11. Which specimen types does Xpert Xpress SARS-CoV-2 use?

Appropriate sample types for testing include nasopharyngeal (NP), nasal, mid-turbinate, or oropharyngeal swabs in UTM/VTM or saline, and nasal wash/aspirates in UTM/VTM or saline.#

12. Is Xpert Xpress SARS-CoV-2 CLIA Waived?

Yes, Xpert Xpress SARS-CoV-2 is authorized to be run on the GeneXpert Xpress System in point of care settings. As such, the FDA deems this to be a CLIA waived test that can be used in settings operating under a CLIA Certificate of Waiver or Certificate of Compliance. The test is 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 and an explanation from the FDA can be found in their FAQs.ƚ

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.

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 only; reporting of negatives in approximately 45 minutes.
^ Product in development. Not for use in diagnostic procedures. Not reviewed by any regulatory body.
# See package insert for details, types may vary by system.
ƚ https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2

The Emergency Use Authorization (EUA) authority under section 564 allows FDA to facilitate availability and unapproved uses of medical countermeasures needed to prepare for and respond to Chemical, Biological, Radiological, or Nuclear emergencies.

Emergency Use Authorization of Medical Products and Related Authorities.

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