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COVID-19: FDA Warns Of Potential Risks Of Antibody Tests

 
• By Elizabeth Orr

The US agency’s decision to allow developers to distribute tests that detect COVID-19 in human blood without going through a clearance process has led to some misleading marketing, the agency warned in two recent statements.

Coronavirus

Serology, or antibody, tests promise to be one of the key tools in tracking and stopping the spread of COVID-19. But some manufacturers may be taking advantage of the ongoing pandemic by making misleading claims in their test marketing, the FDA warned in two recent statements.

The tests detect COVID-19 antibodies in the blood. They help identify people who have had the virus and recovered, developing antibodies that may protect them from future infection, FDA commissioner...

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More from Policy & Regulation

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