The U.S. Food and Drug Administration on Saturday announced it has issued an emergency use authorization that allows the laboratory Quest Diagnostics to pool samples from up to four individuals to test for COVID-19.
This is the first COVID-19 diagnostic test in the United States to be authorized for use with pooled samples, the agency said in a statement.
“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,” FDA Commissioner Dr. Stephen Hahn said in the statement. “Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.”
Sample pooling allows multiple people to be tested at once. The samples are collected and then tested in a pool or “batch” using just one test. If the pool tests positive, this means one or more of the people tested in that pool may be infected with the virus. Each of the samples would then have to be tested again individually.
The FDA last month published guidance for developers that want to make and use tests for pooled samples.
In late June, Dr. 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 US experienced a surge in Covid-19 cases.
Fauci also touted the strategy during a Senate committee hearing, saying pool testing for coronavirus could be a useful tool as schools look to reopen in the fall.
Pool testing helps “get a feel for the penetrance of infection in a community, rather than testing multiple each individual person, which takes resources and time,” Fauci said.
Dr. Deborah Birx, the White House coronavirus response coordinator, also spoke about how pool testing can improve the country’s testing capacity.
“If you look around the globe, the way people are doing a million tests or 10 million tests is they’re doing pooling,” Birx said during an online conference of the American Society for Microbiology late last month. “Pooling would give us the capacity to go from a half a million tests a day to potentially 5 million individuals tested per day by those poolings.”
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.
Quest said in a statement it expects to deploy the testing technique at two of its laboratories by the end of next week, and additional laboratories will follow.
View original article here Source