COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Authorizes First SARS-CoV-2 Antibody Test That Can be Performed at the Point of Care

FDA maze of regulations

COVID-19 serology testing receives new approval allowing POC use

The US Food and Drug Administration (FDA) announced Sept. 23, 2020, that a previous emergency use authorization (EUA) for a SARS-CoV-2 antibody test has been reissued to permit point-of-care (POC) testing. The Assure COVID-19 IgG/IgM Rapid Test Device received its initial EUA in late July, but this EUA now authorizes the test for POC use using fingerstick blood samples collected in patient care settings such as doctors’ offices. The new EUA still requires that the test only be used by a CLIA-certified laboratory.

“Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” FDA Commissioner Stephen M. Hahn, MD, said in a statement announcing the new EUA. “Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test. As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests.”

The FDA notes in its press release announcing the new EUA, “The Assure COVID-19 IgG/IgM Rapid Test Device is currently the only FDA authorized COVID-19 POC serology test and is available by prescription only.” Serology testing should not be assumed to indicate immunity, and it cannot be used to diagnose active infection, according to the FDA.

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