Post by icemandios on Nov 4, 2022 15:10:07 GMT
News Brief from 360Dx
Nov 04, 2022 | staff reporter
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NEW YORK – The US Food and Drug Administration this week revised the authorized uses and required updates to its list of SARS-COV-2 antigen tests that have received Emergency Use Authorizations. The revision requires test developers to make changes related to product labeling regarding repeat or serial testing. For a test that was previously authorized for testing of symptomatic individuals, that test is now authorized for use at least twice over three days with a minimum of 48 hours between tests. If a test was previously authorized for asymptomatic individuals, that test is now authorized for use at least three times over five days with at least 48 hours between tests. The revisions were made based on data that show repeating testing using COVID-19 antigen tests after a negative result increases the chance of an accurate result in people with and without symptoms.
Nov 04, 2022 | staff reporter
Save for later
NEW YORK – The US Food and Drug Administration this week revised the authorized uses and required updates to its list of SARS-COV-2 antigen tests that have received Emergency Use Authorizations. The revision requires test developers to make changes related to product labeling regarding repeat or serial testing. For a test that was previously authorized for testing of symptomatic individuals, that test is now authorized for use at least twice over three days with a minimum of 48 hours between tests. If a test was previously authorized for asymptomatic individuals, that test is now authorized for use at least three times over five days with at least 48 hours between tests. The revisions were made based on data that show repeating testing using COVID-19 antigen tests after a negative result increases the chance of an accurate result in people with and without symptoms.