FDA approves Quest coronavirus test for ‘pooled’ sample use

The U.S. Food and Drug Administration (FDA) on Saturday reissued an emergency use authorization to Quest Diagnostics to authorize a coronavirus test with pooled samples.

In an FDA news release, officials said sample pooling is an important public health tool because it allows for more tests with fewer resources.

The Quest test marks the first COVID-19 diagnostic test to get authorization for pooled samples, according to the statement.


With Quest’s SARS-CoV-2 rRT-PCR test, swab samples from four individuals are tested in a pool at once.

If the pool is positive, it means at least one of the individuals in that pool may be infected. Each of the samples would then be retested individually.

With the pooled samples, the FDA expects fewer tests run overall, which saves on testing supplies.

Also, more tests can be run at the same time so most patients would see their results faster, officials say.

“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 Dr. Stephen M. Hahn, FDA commissioner. “Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.”

The testing strategy is said to be most efficient in areas with a low prevalence, where most of the tests are expected to come back negative.

The pooling dilutes viral material, and officials were concerned it would make for a harder time detecting positive samples.

However Quest’s validation data reportedly demonstrated that its test correctly identified all pooled samples with a positive sample.

According to the release, the Quest test, initially authorized on March 17, is still authorized to test individual samples collected by their health care provider from people with suspected infection, among its other approvals for use.

The FDA is said to be working with a number of diagnostic test developers to facilitate new approaches and get more tests to more Americans faster.