Agency Green Lights First SARS-CoV-2 Tests for Sample Pooling

Revising an Emergency Use Authorization (EUA) to permit a new clinical use is usually pretty routine stuff. But the expanded EUA the FDA announced on July 18 was both unprecedented and significant because it was the first time the agency has given the green light for use of a previously cleared test on pooled samples.

The Quest SARS-CoV-2 Test

The Sir Edmund Hillary of the sample poolers is Quest Diagnostics’ SARS-CoV-2 RNA test, which initially received EUA back in March. The reissued EUA allow for use of the test 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 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 enables testing labs to get the most out of testing resources and overcome supply shortages. But there’s a tradeoff: Because pooling dilutes the nucleic acids produced by the SARS-CoV-2 virus, it creates the risk of false negatives. To secure the EUA expansion for the SARS-CoV-2 RNA test, Quest provided the FDA clinical data showing that none of a total 3,091 specimens from a population with a prevalence rate of 1 to 10 percent would have come back falsely negative had the specimens been pooled. Quest began immediately to perform pooled sampling testing with the assay starting with its laboratories in Marlborough, MA, and Chantilly, VA.

LabCorp Gets OK for Pooling & Asymptomatic Screening

 Less than a week later, the FDA announced that LabCorp’s COVID-19 RT-PCR Test had received the second expanded EUA for pooled SARS-CoV-2 testing. The LabCorp test is authorized for human specimen collection at home using the Pixel by LabCorp or other home sample collection kits authorized for use with LabCorp’s test, or by a healthcare provider. However, only samples collected by healthcare providers may be pooled using the test, the FDA noted. The expanded EUA also allows the test to be used for testing the broad population under the FDA’s new asymptomatic screening guidance, making it the first SARS-CoV-2 test to gain that distinction.

Here are some of the other key FDA EUAs and clearances announced in July:

New FDA Emergency Use Authorizations (EUAs) & Approvals

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

NEW CE MARKINGS IN EUROPE

Other international clearances announced during the period: