US FDA issues first emergency use authorization for COVID-19 pool testing

WASHINGTON -- The US Food and Drug Administration on Saturday issued an emergency use authorization (EUA) to Quest Diagnostics that allows pool samples from up to four individuals to test for COVID-19.

The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.

Sample pooling is an important public health tool because it allows for more people to be tested quickly using fewer testing resources, said FDA.

Sample pooling does this by allowing multiple people - in this case four individuals - to be tested at once. The samples collected from the four individuals are then tested in a pool or "batch" using one test, rather than running each individual sample on its own test.

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

Because the samples are pooled, it is expected that fewer tests are run overall, meaning fewer testing supplies are used and more tests can be run at the same time, allowing patients to receive their results more quickly in most cases, according to FDA.

"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.

"Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population," he said.