The Food and Drug Administration (FDA) has issued emergency use authorization for two point-of-care diagnostics for the qualitative detection of SARS-CoV-2, the virus causing coronavirus disease 2019 (COVID-19).
The Xpert® Xpress SARS-CoV-2 test (Cepheid) provides detection of SARS-CoV-2 in approximately 45 minutes with less than a minute of hands on time to prepare the sample. The test is designed for use in high- and moderate-complexity CLIA-certified laboratories as well as in certain patient care settings. The Company plans to make it available by March 30.
Additionally, the Accula™ SARS-CoV-2 Test from Mesa Biotech allows for rapid molecular SARS-CoV-2 testing with diagnostic results in 30 minutes. The palm-sized system can be used at temporary screening facilities, physician offices, urgent cares, and long-term care facilities. The Company plans to start shipping the test immediately.
“Our dedicated team at the FDA has been working nonstop to expedite the review and authorization of novel diagnostics during the COVID-19 public health emergency,” said FDA Commissioner Stephen Hahn, MD. The Agency is also actively and aggressively monitoring the online marketplace for unauthorized fraudulent COVID-19 test kits that are being advertised as at-home tests for COVID-19.
Healthcare professionals and consumers are urged to report any fraudulent test kits by sending an email to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.
For more information visit fda.gov.