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

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FDA Issues EUA for First Home Collected COVID-19 Antibody Test

FDA maze of regulations

COVID-19 antibody test gets the first EUA allowing at-home collected antibody testing

The US Food and Drug Administration (FDA) has issued the first-ever emergency use authorization (EUA) for a home collected COVID-19 antibody test. While many EUAs exist for at-home collection COVID-19 diagnostic tests, this EUA marks the first time that antibody testing can be offered this way. The new EUA was issued for the Symbiotica COVID-19 Self-Collected Antibody Test System.

“The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” said Jeffrey Shuren, MD, JD, Director of the FDAs Center for Devices and Radiological Health. The FDA will continue to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options.

The Symbiotica test allows consumers to collect blood using a finger stick, then send the dried sample to Symbiotica for laboratory analysis. As the first at-home collected COVID-19 antibody test to receive an EUA, the Symbiotica test is the first time a COVID-19 antibody test has moved out of exclusively being collected in a healthcare environment. This development may signal a move toward more consumer-friendly antibody testing.

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