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The FDA has created an expedited pathway for manufacturers seeking to obtain Emergency Use Authorization for products used in serial testing to detect SARS-CoV-2 in asymptomatic individuals. Currently, most tests are authorized for diagnosing people with a suspected infection.
Serial testing involves testing the same person more than once over a few days to increase the chances of detecting asymptomatic infection that a single test might not detect. The simplified recommendations apply to molecular and antigen tests used serially in any location, from point-of-care settings to homes, schools, airports, or sports venues.
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A supplement to existing policy allows manufacturers whose tests for symptomatic individuals have achieved a positive percent agreement of at least 80% to request authorization for serial testing in asymptomatic people before they have validation data for that group.
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