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(CNN) – The United States Food and Drug Administration (FDA) will now require that manufacturers of antibody tests immediately seek FDA clearance, as the agency aims to monitor unproven and fraudulent tests that have flooded the market.
The new policy, announced Monday, requires commercial manufacturers to submit emergency authorization requests, along with validation data for their antibody tests, within 10 business days. The FDA is also establishing specific performance recommendations for all test developers.RELATED
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The agency also said it has the ability, in collaboration with the National Cancer Institute, to independently validate antibody tests on the market.
The measure to require authorization reverses a policy that the FDA established in mid-March, which loosened approval standards and allowed companies to sell antibody tests, also known as serological tests, without providing evidence that the tests worked. It quickly became apparent that many of the tests were unreliable, and some companies marketed tests that either falsely claimed to be FDA approved or licensed, or claimed that antibody tests could be used to diagnose covid-19.
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Antibody tests are used to verify previous covid-19 infection and can provide a better idea of what part of the population has already been infected and may have some immunity to the virus. It is still unclear whether the presence of antibodies means that someone is immune or how long that immunity could last.
To date, at least 10 antibody tests have been authorized under an individual emergency use authorization, most in the past few days, and more than 200 antibody tests are undergoing a pre-EU review or a review of emergency use authorization.