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FDA Issues List of SARS-CoV-2 Antibody Tests That Have Been Removed from the FDA’s Notification List

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SARS-CoV-2 serology tests that failed to meet the FDA’s EUA requirement are now listed on the FDA’s website.

Until recently, the performance of serological tests to identify the COVID-19 antibodies has been mostly unknown. 

In its earliest guidance, the Food and Drug Administration (FDA) only required that commercial manufacturers of SARS-CoV-2 serology tests provide notification to the FDA that they had validated and intended to distribute their serology tests. In exchange for little supporting performance data, manufacturers that provided this notification to the FDA had their assay listed on a “notification list” provided by the FDA.

However, on May 4, 2020, the FDA changed the rules and required all companies seeking to sell serological tests in the United States to apply for emergency use authorization (EUA). Those who had previously developed antibody tests, as well as those developing new tests, would have to submit information for their EUA within a reasonable period of time, as short as 10 business days for those serology tests that were already listed on the FDA’s notification list. 

Now that reasonable time has passed, the FDA has released the names of SARS-CoV-2 serology tests as “Removed – Should Not Be Distributed”. As of June 3, 2020, at least 30 antibody tests were recorded on this list. Those tagged with an asterisk were voluntarily withdrawn, according to the FDA, which plans to update the list as developments warrant. 

According to the FDA, two primary issues will trigger removal of a new COVID-19 antibody test: when an EUA request is not submitted by a commercial manufacturer of a serology test within a reasonable period of time, or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner. 

Related Resources:

FDA Announces List of SARS-CoV-2 Serology Tests That Have Been Removed from Notification ListList of Tests Removed From Antibody Test Notification List

COVID-19 TESTING DATA

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Robert L. MichelIn these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

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