FDA authorizes novel point-of-care antigen test

Aug 20, 2020 - 03:25 PM
FDA product update

The Food and Drug Administration yesterday authorized emergency use of a rapid point-of-care antigen test to detect SARS-CoV-2 directly from nasal swab specimens.

Laboratories certified under the Clinical Laboratory Improvement Amendment to perform moderate, high or waived complexity tests and health care providers with a CLIA certificate of waiver, compliance or accreditation may use the test, made by LumiraDx UK Ltd.

Assistant Secretary for Health Admiral Brett Giroir, M.D., said the novel “low cost” test “will significantly contribute to our scaling up and expanding testing platforms for SARS-CoV-2. This technology has built-in digital connectivity, almost everything we hope for in new testing platforms coming to market. Furthermore, its flexibility to perform diagnostic assays to detect indicators of various diseases, including inflammatory markers, could be transformative in providing improved access to quality health care.”

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