“Load and go” technology delivers total automation for up to 2,000 tests a day.
Coverage, plus
Accuracy, plus
Peace of mind
That’s the PCRplus advantage. From Cepheid
.
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.
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.
Learn About SARS-CoV-2 Testing
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
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.
Overview: How Cepheid's SARS-CoV-2 Test Cartridge (COVID-19) is Made, with CMO Dr. David Persing
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)
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).
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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.