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U.S. Department of Health and Human Services

Cepheid – Xpert Xpress SARS-COV-2/Flu/RSV test

ASPR’s Portfolio of COVID-19 Medical Countermeasures under EUA

The Cepheid Xpert Xpress SARS-CoV/Flu/RSV test will detect viral nucleic acid and provides one test that detects and differentiates COVID-19 and Flu during the upcoming Flu season. The test will operate on all of Cepheid’s widely-placed GeneXpert and Infinity systems for laboratory testing, as well as their Xpress instrument in point-of-care settings.

Emergency Use Authorization

On September 24, 2020, FDA issued an Emergency Use Authorization (EUA) to allow Cepheid’s Xpert Xpress SARS-COV-2/Flu/RSV to be used to detect and differentiate SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) viral RNA. FDA reissued the EUA on October 1, 2020.

  • This page last reviewed: October 26, 2020