FDA Authorizes First Point-of-Care Antibody COVID-19 Test

The Assure COVID-19 IgG/IgM Rapid Test Device is a lateral flow assay and is authorized for use with venous whole blood, serum, plasma and fingerstick whole blood. The serology POC test, unlike POC COVID-19 diagnostic tests, uses a blood sample from the fingertip to run the test. The test was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. The EUA has now been reissued to authorize the test for POC use using fingerstick blood samples.

The latest authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing. 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.

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

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US Food and Drug Administration (FDA)