Labcorp Gets EUA for Over-the-Counter COVID-19 and Respiratory Virus Test

The FDA has granted Emergency Use Authorization to Research Triangle Park, N.C.-based Labcorp for a direct-to-consumer seasonal respiratory virus test.

The polymerase chain reaction test is intended for the simultaneous detection and differentiation of RNA from SARS-CoV-2, influenza A and B, and respiratory syncytial virus.

The test uses nasal swab specimens collected at home from people with symptoms of respiratory viral infection consistent with COVID-19, using the company’s Pixel home collection kit.

Analysis of test samples is limited to the Center for Esoteric Testing, Burlington, N.C., or other Labcorp-designated laboratories that meet the requirements to perform high-complexity tests.