FDA issues first emergency use authorization for Covid-19 pool testing

This is the first Covid-19 diagnostic test in the United States authorized for use with pooled samples, the agency said in a statement.

“This USA for pooling samples is an important step in bringing more Covid-19 tests to more Americans faster while preserving test supplies,” FDA Commissioner Dr. Stephen Hahn said in the statement. . “Pooling samples becomes especially important as infection rates decrease and we begin to analyze larger portions of the population.”

Pooling samples allows multiple people to be analyzed at once. Samples are collected and then tested in a group or “batch” using only one test. If the group tests positive, this means that one or more of the people tested in that group may be infected with the virus. Each of the samples would have to be retested individually.

In late June, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the White House Coronavirus Task Force was “seriously considering” group testing as a new strategy to improve testing , since the United States experienced an increase in Covid -19 cases.

Fauci also touted the strategy during a Senate committee hearing, saying group tests for coronavirus could be a useful tool as schools look to reopen in the fall.

Group testing helps “get a feel for the infection’s penetration into a community, rather than testing multiple individual people, which requires resources and time,” Fauci said.

Dr. Deborah Birx, White House coronavirus response coordinator, also discussed how group testing can improve the country’s testing capacity.

“If you look around the world, the way people are doing a million tests or 10 million tests is by doing clusters,” Birx said during an online conference of the American Society for Microbiology late last month. “The pool would give us the ability to go from half a million tests per day to potentially 5 million people screened per day by those pools.”

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

Quest said in a statement that it expects to deploy the test technique at two of its labs by the end of next week, and additional labs will follow.

CNN’s Jim Acosta, Sam Fossum, Amanda Watts, Jacqueline Howard and Arman Azad contributed to this report.

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