The U.S. Food and Drug Administration (FDA) issued its third Emergency Use Authorization (EUA) for an antigen test to detect SARS-CoV-2, according to a press release from the FDA.
The EUA was issued to LumiraDx, based in London, for the LumiraDx SARS-CoV-2 Ag Test, which is used with the LumiraDx Platform for the direct and qualitative detection of nucleocapsid proteins in nasal swab specimens from patients suspected of COVID-19. The system reports test results in under 12 minutes.
The EUA authorizes the use of the test in high and moderate complexity laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA), as well as at the point-of-care (POC) setting operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
