BioCentury
ARTICLE | Regulation

First EUA for pooled COVID-19 test points to effect of prevalence on performance

July 21, 2020 12:05 AM UTC

FDA’s first authorization of a pooled COVID-19 test makes it clear this resource-saving approach is best reserved for populations where disease prevalence is low, highlighting the need to quickly adapt testing strategies in response to infection spikes.

The agency announced Saturday it granted Emergency Use Authorization (EUA) to Quest Diagnostics Inc. (NYSE:DGX) to use sample pooling with its reverse transcription polymerase chain reaction (RT-PCR)-based test, previously authorized for use on individual patient samples. ...