FDA Grants Emergency Use Authorization for OnsiteGene Molecular COVID-19 Test

Original from: genomeweb

The US Food and Drug Administration this week granted Emergency Use Authorization for OnsiteGene's Hi-Sense COVID-19 Molecular Testing Kit 1.0.

The RT-qPCR-based assay is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, mid-turbinate nasal, anterior nasal, and nasal swab specimens, as well as nasal aspirates, nasopharyngeal wash/aspirates, and bronchoalveolar lavage specimens.

The test may only be performed by labs CLIA-certified to perform high-complexity tests, according to the FDA.

Source: FDA Grants Emergency Use Authorization for OnsiteGene Molecular COVID-19 Test