COVID test EUAs updated with pooled serial testing option

Regulatory NewsRegulatory News
| 21 April 2021 | By Kari Oakes 

The US Food and Drug Administration (FDA) has taken steps to make it easier to pool test samples for many molecular diagnostic tests for SAR-CoV-2, the virus that causes COVID-19.
The agency’s amendment to many test emergency use authorizations (EUAs) now allows sample pooling to screen asymptomatic individuals when the testing is performed at least once weekly as part of a screening strategy.
“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,” said Jeffrey Shuren, MD, JD, head of FDA’s Center for Devices and Radiological Health, in announcing the new steps.
The amendment, which applies only anterior respiratory specimens, helps laboratories, health care facilities, and others who are conducting screening tests to conserve supplies and reduce workload by pooling samples. The pooling strategy can be effective in an environment where the probability of positive tests is low, as when disease prevalence rates are low or when screening asymptomatic individuals. Only when a pooled sample returns a positive result is it necessary to test individual samples.
“If a test developer has self-certified it has validated its test for pooling, FDA will add that test to a list of tests that can be used for pooling nasal specimens as part of a serial testing program,” explained Shuren.
Holders of EUAs for molecular diagnostic tests for SARS-CoV-2 that use anterior respiratory specimens who wish to use the pooled approach should notify FDA of their intent, providing validation data if they desire to pool more than three specimens, along with the pooling procedures they intend to use.
The full list of tests authorized for additional indications under this amendment will be publicly viewable; FDA will also add the term “pooled serial screening” as an attribute for authorized tests in its main EUA list.
FDA previously issued a new supplemental template that developers can use to seek EUA to use some tests for screening with serial testing. “This Pooling and Serial Testing Amendment builds upon that earlier action,” wrote FDA in its announcement. (RELATED: FDA smooths the paths for COVID screening tests, Regulatory Focus 17 March 2021)


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Tags: CDER, coronavirus, FDA, US

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