For the first time, the U.S. Food and Drug Administration has greenlit pool testing to detect the novel coronavirus, potentially allowing more Americans to be tested using fewer resources.
One company, Quest Diagnositics, has been granted an emergency use authorization (EUA) allowing its test to be used with a batch of specimens at a time — up to four different swabs.
If the overall sample comes back positive, then the individuals in the pool are retested in order to determine who has COVID-19.
“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 Stephen M. Hahn said in a statement.
“Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.”
The FDA noted that while there’s a possibility that pooling specimens may dilute the virus and therefore may make it harder to identify, Quest Diagnostics’ validation data showed the test identified all positives within the pooled samples evaluated.
Researchers told Global News last month that the testing strategy could help manage bottlenecks and ultimately aid in reopening group settings.
But as of last month, pooled testing isn’t being formally conducted at Canada’s national lab.
Health Canada said scientists at the National Microbiology Laboratory in Winnipeg are conducting research to determine the accuracy of pooling specimens for point-of-care, or rapid test devices, due to a global shortage of lab supplies used with those devices.
The agency did not immediately respond to a request for comment on Saturday.
The emergency approval comes as the U.S. grapples with record increases in coronavirus cases and calls for greater access to testing.
For the second day in a row, cases on Friday rose by at least 70,674 after climbing by a record 77,499 on Thursday, the largest increase posted by any country since the pandemic started, according to a Reuters tally.
— With files from Reuters, Maryam Shah and Patrick CainView link »