FDA issues first emergency use authorisation for COVID-19 pool testing

The US Food and Drug Administration (FDA) on Saturday (local time) issued an emergency use authorisation (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 authorised for use with pooled samples, Xinhua news agency reported.

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

The samples are collected and 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 is 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.

The FDA last month published guidance for developers who wanted to make and use tests for pooled samples.

In late June, Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said the White House coronavirus task force was "seriously considering" pool testing as a new strategy to improve testing as the nation experienced a surge in Covid-19 cases.

In its statement, the FDA said that while there is a "concern that combining samples may make it more difficult to detect positives since pooling in the laboratory dilutes any viral material present in the samples," Quest's validation data correctly identified all of the pooled samples that contained a positive sample. 

-ANI

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