CDC Guidance on Pooled Testing for SARS-CoV-2

August 7, 2020

The Center for Disease Control and Prevention (CDC) released interim guidance for use of pooled testing for SARS-CoV-2 screening. The guidance defines diagnostic testing, screening testing, and surveillance testing, specifying that if a pooled test is positive or indeterminate, then all the specimens in the pool need to be re-tested individually to determine which samples are positive.

The guidance also notes specific reporting requirements if a pooled testing strategy is used for diagnostic, screening, and surveillance testing. Additionally, it notes that COVID-19 assays and test systems used for diagnostic or screening testing, including those used for pooling, must have received an emergency use authorization from the Food and Drug Administration (FDA) as described in FDA’s Policy for COVID-19 Tests. Per the FDA’s FAQs on Testing for SARS-CoV-2 the FDA generally does not regulate surveillance testing.