Agency Streamlines Authorization of COVID-19 Molecular Test Pooling for Screening Programs

Last July, in an effort to meet the desperate need for high throughput COVID-19 testing, the U.S. Food and Drug Administration (FDA) issued the first clearance for use of a previously authorized test on pooled samples to Quest Diagnostics’ SARS-CoV-2 RNA test (See DTET, Sept. 8, 2020). More than two dozen other COVID-19 tests have received Emergency Use Authorization (EUA) since then. Now the agency has doubled down by promulgating new rules making it easier for makers of previously authorized molecular tests to get expanded EUA for pooling. COVID-19 Test Pooling Pooling is a technique that enables laboratories to expand throughput by testing a batch of combined specimens at once. If the pool tests negative, it becomes unnecessary to test the constituent samples. The tradeoff is that the pooled samples must be diluted, which makes the nucleic acids produced by the SARS-CoV-2 virus more difficult to detect thus increasing the risk of false negatives. The other downside is that pooling can backfire and consume more testing time and resources when the sample comes back positive because the samples then need to be tested individually to detect the source(s) of the positive result. For these reasons, the FDA has been historically […]