FDA has new way to add pooled serial screening to COVID-19 molecular tests

April 21, 2021

The U.S. Food and Drug Administration (FDA) streamlined the process for authorizing molecular tests to screen asymptomatic people for SARS-CoV-2 using pooled anterior nasal respiratory specimens in serial testing programs, according to a news release.

If a developer of a molecular test with emergency use authorization (EUA) self-certifies that it has validated the test for pooling, the FDA will add that test to a list of tests that can be used for pooling.

This exception, or amendment, to the usual EUA process applies only to pooling of anterior nasal respiratory specimens for testing individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week as part of a serial testing program, the FDA said.

Pooling, the process of combining multiple specimens together to more quickly test groups of people for SARS-CoV-2, can be an efficient approach for a serial testing program that tests many people on a routine basis, the FDA noted.

To utilize this approach, the FDA said EUA holders must submit a notification to FDA with specific required information, including validation data (if requesting to pool more than three specimens) and pooling procedures.

After this notification is given, the test will be identified on the FDA website and updated labeling will be posted with the test’s EUA on the FDA website.

The public, including organizations purchasing tests to use for testing pooled specimens in serial testing programs, will be able to see the full list of tests authorized for any additional indication under this amendment on the FDA website as well as search the main EUA list on the FDA website to quickly find tests authorized for “pooled serial screening,” which will be added as an attribute for each test amended by this authorization.

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