AMERICA — On July 18, the U.S. Food and Drug Administration issued an emergency use authorization to Quest Diagnostics, allowing for sample pooling in diagnostic testing for the coronavirus.
This means that up to four individuals can be tested at once, in a pool or “batch,” as opposed to testing each individual independently. This will allow for more people to be tested quickly while using fewer testing resources.
If the pool tests positive, then each individual will be tested separately to determine who in the pool is positive for COVID-19. If it tests negative, all individuals are cleared.
The FDA expects that this testing strategy will be most effective in areas with low prevalence, as most results are expected to be negative.
“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 M. Hahn, M.D. “Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.”
While there is some concern that combining samples will make it more difficult to identify positive results, Quest’s data has correctly identified all of the pooled samples with positive samples so far.
In a statement, Quest said that they will start sample pooling at two locations by the end of the week, with other locations following soon after.
Dr. Deborah Birx, the White House coronavirus response coordinator, spoke about the effectiveness of pool testing, stating at an online conference of the American Society for Microbiology that “If you look around the globe, the way people are doing a million tests or 10 million tests is they’re doing pooling. 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.”