Xpert® Xpress SARS-CoV-2 has received FDA Emergency Use Authorization
A rapid, near-patient test for the detection of the 2019 novel coronavirus that causes COVID-19
Xpert® Xpress SARS-CoV-2*
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 approximately 45 minutes 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 23,000 placements.
*For Use Under an Emergency Use Authorization (EUA) Only. Test pending submission and review by international regulatory agencies.
Test Verification Protocol
Learn About Xpert Xpress SARS-CoV-2
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 a rapid and easy to use test that enables healthcare providers to obtain a result within an hour of obtaining a patient sample. The test runs on our GeneXpert system, which has 23,000 placements worldwide, running a menu of over 20 US-IVD and CE-IVD tests. We began developing the Xpert Xpress SARS-CoV-2 test in January and have since validated its ability to detect genomic information unique to the SARS-CoV-2 virus.
3. How fast is 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 it can be achieved faster than any other test available. It takes less than a minute to prepare the cartridge with the patient sample and approximately 45 minutes for GeneXpert to determine a result 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 on March 20, 2020. Concurrently, Cepheid is working closely with other regulatory agencies to attain the relevant clearances, including CE-IVD, in order to ensure we deliver the test globally to those countries most in need.
5. When do you expect the test to be available?
Our plan is to start shipping Research Use Only (RUO) and Emergency Use Authorization (EUA) tests before the end of March.
6. How do I get a 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?
GeneXpert II, IV, XVI, Infinity 48, Infinity 80, and Xpress Systems.
10. What strains of coronavirus will be detected by the test?
The test is designed to detect only SARS-CoV-2.
11. Which specimen types will Cepheid’s test use?
Appropriate sample types for testing include nasopharyngeal swabs (NPS) in UTM/VTM, nasal aspirates, and nasal washes.*
12. 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.
Meet our Game-Changing Platform
With over 20,000 installed systems worldwide, the GeneXpert System is the molecular testing platform of choice for most laboratory specialists. See how it’s helping clinicians everywhere make a more positive impact.
*See package insert for details, types may vary by system.
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.