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Home » 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
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.
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