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LabCorp Coronavirus Test EUA Reissued to Expand Sample Types for Pooled Testing

NEW YORK — The US Food and Drug Administration said on Wednesday that it has reissued an Emergency Use Authorization for Laboratory Corporation of America's COVID-19 RT-PCR Test to include changes to the type of samples that can be used for pooled testing.

The test first received EUA in March for the detection of SARS-CoV-2 nucleic acid in upper and lower respiratory specimens collected by a healthcare provider from individuals suspected to be infected with the virus. The EUA was reissued in April to include nasal swab specimens self-collected using the Pixel by LabCorp COVID-19 Test Home Collection Kit, and then again in July to include the test's use with asymptomatic individuals and to allow for pooled testing with samples collected under observation. 

With the latest reissuance of the EUA, dated Sept. 18, LabCorp's test may be used for pooled testing with samples self-collected under healthcare provider observation or using a home collection kit. 

Separately, earlier this month, Burlington, North Carolina-based LabCorp received FDA EUA for an RNA extraction method for use in SARS-CoV-2 testing.