Viracor Eurofins Clinical Diagnostics Receives US FDA Emergency Use Authorization (EUA) for Viracor SARS-CoV-2 assay (originally issued 4/6/20)
Device: Viracor SARS-CoV-2 assay Company: Viracor Eurofins Clinical Diagnostics
Indication: This test is authorized for the following indications for use: Qualitative detection of SARS-CoV-2 viral ribonucleic acid (RNA) in nasopharyngeal swab, nasal swab, nasopharyngeal wash, nasal wash, oropharyngeal swab and bronchoalveolar lavage from individuals suspected of COVID-19 by their healthcare provider (HCP). This test is also authorized for use with the EmpowerDX At-Home COVID-19 PCR Test Kit for individuals to self-collect nasal swabs at home, when determined by a HCP to be appropriate based on the results of an online COVID-19 questionnaire. Qualitative detection of nucleic acid from the SARS-CoV-2 in pooled samples containing up to five individual nasopharyngeal swab specimens that are collected by a HCP using individual vials containing transport media, from individuals suspected of COVID19 by their HCP. Testing is limited to Viracor Eurofins Clinical Diagnostics, located at 1001 NW Technology Dr., Lee’s Summit, MO which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, and meets the requirements to perform high complexity tests.