US FDA issues first EUA for COVID-19 pool testing

Cornelia Mascio
Luglio 20, 2020

The federal government has introduced a new way to speed up coronavirus testing without depleting medical supplies.

In an effort to ease the diagnostic logjam the United States is facing with the coronavirus surging in various parts of the country, the Food and Drug Administration on Saturday granted an emergency use authorization for pooled COVID-19 testing.

Quest Diagnostics Inc. will be able to test samples containing as many as four individual swab specimens, the agency said on Saturday in an emergency-use authorization.

"Instead of taking an individual blood sample, a nasal sample from somebody, you take a whole bunch of them and you put them together, and you run a test on that whole batch", explained Dr. Amesh Adalja, senior scholar at Johns Hopkins University Center for Health Security.

"This EUA for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies", said FDA Commissioner Stephen Hahn.

If the pool is positive, it means that one or more of the individuals tested may be infected, so each of the samples in that pool are tested again individually, according to FDA.

"Additionally, officials claimed Quest's procedures for validating data tackles any problem that could arise when samples are combined in a laboratory setting". "Given what we know now about coronavirus infections, it seems like the benefits are going to greatly outweigh the loss of detection you get". Places experiencing more severe outbreaks, on the other hand, are still better off with individual testing.

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