FDA Provides Guidance on Pooled Samples, Asymptomatic Testing for SARS-CoV-2

In a move it described as a step forward in getting more COVID-19 tests to more Americans more quickly, the US Food and Drug Administration on Tuesday provided developers with new Emergency Use Authorization guidance on the validation processes it expects for pooling samples and for screening of asymptomatic people.

In the updated template for molecular diagnostic tests, there are two pathways to the asymptomatic and pooling indications – one for a previously unauthorized test, and one for a test that already has an EUA.

For an asymptomatic screening claim, FDA recommends in its template that the test be evaluated in a clinical study of the intended population. The number of patients should be enough to detect 20 positive samples, with a positive percent agreement, or PPA, with a comparator test of 95 percent, and negative percent agreement, or NPA, of 98 percent.

Source: https://www.360dx.com/pcr/fda-provides-guidance-pooled-samples-asymptomatic-testing-sars-cov-2