www.fdanews.com/articles/207979-labcorp-gets-eua-for-over-the-counter-covid-19-and-respiratory-virus-test
Labcorp Gets EUA for Over-the-Counter COVID-19 and Respiratory Virus Test
May 26, 2022
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.