FDA Breaks New Ground by Authorizing SARS-CoV-2 Tests for Sample Pooling
It’s not uncommon for the FDA to revise the Emergency Use Authorization (EUA) for a particular diagnostics test to permit a new clinical use. In most cases, these expansions don’t even get an official announcement. But on July 18, the agency saw fit to pull out all of the stops and officially announce an EUA that was both unprecedented and significant because it allowed for COVID-19 testing on pooled samples. The Quest SARS-CoV-2 Test The distinction of being the first test approved for pooled testing went to Quest Diagnostics’ SARS-CoV-2 RNA test, which initially received EUA back in March. The expanded EUA allows the test to be used with pooled upper respiratory specimens in sample pools comprised of four individuals. “The new update allows Quest to test 3,600 more tests per day,” noted Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health during a recent agency “town hall” briefing, “and if you add pooling on top of that. . . they can substantially increase the throughput.” Use of pooling takes on particular significance during the current COVID-19 testing supplies shortage because it enables testing labs to get […]
EUA Date | Manufacturer | Product |
July 18 | Quest Diagnostics | SARS-CoV-2 RNA test EUA expanded for pool sampling use |
July 24 | LabCorp | EUA for COVID-19 RT-PCR test and home collection kit reissued for sample pooling and use on asymptomatic patients |
July 31 | University of California San Diego Health | UCSD RC SARS-CoV-2 Assay gets EUA for sample pooling |
Aug. 3 | Poplar Healthcare | Poplar SARS-CoV-2 TMA Pooling assay gets EUA for sample pooling |
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