GeneXpert® Infinity Systems
“Load and go” technology delivers total automation for up to 2,000 tests a day.
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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.
Xpert® Xpress CoV-2/Flu/RSV plus*
Meet the challenges of the ongoing pandemic with the confidence of a single test to detect and differentiate SARS-CoV-2, Flu A, Flu B, and RSV. Results for all four pathogens in just 36 minutes.
* 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.
Xpert® Xpress CoV-2 plus*
More testing options to support care. Designed with enhanced gene coverage to test symptomatic and asymptomatic patients. Rapid on-demand detection of SARS-CoV-2.
* This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, not for any other viruses or pathogens; and this test is 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.
Learn About SARS-CoV-2 Testing
Video
Cepheid's combination test for SARS-CoV-2, Flu A, Flu B and RSV
Cepheid Receives Emergency Use Authorization For SARS-CoV-2, Flu A, Flu B and RSV Combination Test
Video
Why Cepheid's GeneXpert is ideal for COVID-19 Strategies - High Volume Labs to Point-of-Care Testing
The GeneXpert System was built for simple, reference lab quality PCR testing – on location at medical centers and hospitals or closer to patient in health clinics and nursing homes. At the core of every GeneXpert System is the module (or testing bay) where a test cartridge is loaded onto the machine.
Video
Overview: How Cepheid's SARS-CoV-2 Test Cartridge (COVID-19) is Made, with CMO Dr. David Persing
Video
Cepheid's combination test for SARS-CoV-2, Flu A, Flu B and RSV
Cepheid Receives Emergency Use Authorization For SARS-CoV-2, Flu A, Flu B and RSV Combination Test
Video
Why Cepheid's GeneXpert is ideal for COVID-19 Strategies - High Volume Labs to Point-of-Care Testing
The GeneXpert System was built for simple, reference lab quality PCR testing – on location at medical centers and hospitals or closer to patient in health clinics and nursing homes. At the core of every GeneXpert System is the module (or testing bay) where a test cartridge is loaded onto the machine.
Video
Overview: How Cepheid's SARS-CoV-2 Test Cartridge (COVID-19) is Made, with CMO Dr. David Persing
Press Releases
9/14/21: Cepheid Receives Emergency Use Authorization for Xpert Xpress CoV-2/Flu/RSV plus
3/21/2020: Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test
3/22/20: HHS, DoD collaborate with Cepheid on rapid diagnostics to detect coronavirus infections
2/10/2020: Cepheid Announces Development of Test for New Coronavirus Strain (2019-nCoV)
Cepheid's SARS-CoV-2 Webinars
Laboratory Diagnosis of SARS-CoV-2: Review of Testing Methodologies
Review the SARS-CoV-2 diagnostic landscape, with a focus on performance characteristics. Cover the different types of tests that are being used for SARS-CoV-2 testing and discuss some of the main points for each method.
More...
Xpert Xpress SARS-CoV-2
Understand the current landscape of testing for the SARS-CoV-2 virus, Cepheid’s Emergency Use Authorization (EUA), and a real-world application of the Xpert Xpress SARS-CoV-2* test.
More...
Frequently Asked Questions
Below is a list of common questions and answers for Cepheid’s SARS-CoV-2 tests.
For additional information please Contact Us.
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.
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.^
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).
Click the green Request Information button at the top of this page to be connected with your local Cepheid Sales Representative.
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.
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.#
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.
Learn About Cepheid GeneXpert® Systems