COVID Test EUAs Updated with Pooled Serial Testing Option

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.


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