FDA grants EUA for premier medical at-home Covid assay

The US Food and Drug Administration last week granted Emergency Use Authorization for Premier Medical Laboratory Services’ Diversified Medical Healthcare SARS-CoV-2 Assay.

The real-time RT-PCR-based test is for the qualitative detection of SARS-CoV-2 nucleic acid in anterior nasal swab specimens that are collected at home using the DoINeedaCOVID19Test.com Self-Collection Kit. The test is also authorized for use with anterior nasal swab specimens that are collected using the FDA-authorized RapidRona Self-Collection Kit.

The Diversified Medical Healthcare assay may only be performed by CLIA-certified laboratories designated by Premier Medical, according to the FDA. It uses the same reagents and procedures as Thermo Fisher Scientific’s TaqPath Covid-19 RNase P Combo Kit 2.0, which received EUA from the FDA in mid-2021.

In early 2022, Greenville, South Carolina-based Premier Medical received EUA from the FDA for its PMLS SARS-CoV-2 Assay. 360Dx