NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for a respiratory panel RT-PCR test from Laboratory Corporation of America and a COVID-19 RT-PCR test from Nexus Medical Labs.
The Labcorp Seasonal Respiratory Virus RT-PCR Test is designed for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza viruses A and B, and respiratory syncytial virus RNA in nasopharyngeal, mid-turbinate, and anterior nasal swab specimens. The test may also be used with individual anterior nasal swab specimens collected at home using the Labcorp COVID-19+Flu+RSV Test Home Collection Kit.
The test may only be performed at the Center for Esoteric Testing or other labs designated by Labcorp that are CLIA-certified to perform high-complexity tests, according to the FDA.
Earlier this month, Burlington, North Carolina-based Labcorp received EUA from the FDA for a nonprescription version of the Seasonal Respiratory Virus Test.
The Nexus High Throughput SARS-CoV-2 Assay is designed for the qualitative detection of SARS-CoV-2 nucleic acid in anterior nasal swab specimens that are collected using the Rhinostics Nasal Swab Collection Kit either at home or in a healthcare setting.
Use of the test is limited to Aldatu Diagnostics, the FDA said.