FDA Grants First EUA for Point-of-Care COVID-19 Antibody Test

September 25, 2020

The FDA has issued the first Emergency Use Authorization (EUA) for a point-of-care COVID-19 antibody test, authorizing a rapid test made by Hangzhou, China-based Assure Tech.

The authorization expands a previous EUA given to the test in July, which allowed it to be used in certain labs to identify patients with recent or prior COVID-19 infection. This second EUA allows the test to be used with fingerstick-blood samples in point-of-care settings.

“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,” said FDA Commissioner Stephen Hahn. “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.”

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