NEW YORK — The US Food and Drug Administration said on Monday that it has granted Emergency Use Authorization (EUA) for Viracor Eurofins Clinical Diagnostics' molecular laboratory-developed test (LDT) for SARS-CoV-2 infection.
The Viracor SARS-CoV-2 assay is a real-time RT-PCR test designed for the qualitative detection of specific sequences of the SARS-CoV-2 N gene in nasopharyngeal swab, nasal swab, nasopharyngeal wash, nasal wash, oropharyngeal swab, and bronchoalveolar lavage. It runs on Thermo Fisher Scientific's Applied Biosystems 7500 Real-Time PCR systems, and nucleic acid extractions for the test are performed using the BioMérieux Nuclisens EasyMag or eMAG instrument, the FDA said.
According to the FDA, the test may only be performed at Viracor Eurofins' CLIA-certified laboratory. Last week, the agency released new EUA guidance indicating that molecular-based LDTs for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens can only be performed in the CLIA-certified lab in which the test was developed.
In March, Lee's Summit, Missouri-based Viracor Eurofins entered a partnership to offer the test to the National Kidney Registry's network of member centers.
Separatley, Eurofins, the parent company of Viracor Eurofins, said on Monday that its blood-based antibody test for the coronavirus became available at Boston Heart Diagnostics, also a Eurofins subsidiary.