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Xpert® Xpress SARS-CoV-2
A rapid, near-patient test for the detection of the novel coronavirus that causes COVID-19.
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10 Tests
XPRSARS-COV2-10
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Collection devices
Copan 346N (Nasal Swab) (Pack of 50)
346C
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Test The Solution
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.
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.
In the United States: 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 detection of nucleic acid from SARS-CoV-2, and not for any other viruses or pathogens. 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.
CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.
CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.