NEW YORK – BioMérieux has been granted Emergency Use Authorization by the US Food and Drug Administration for a molecular diagnostic test kit to detect SARS-CoV-2, the virus that causes COVID-19.
The SARS-CoV-2 R-Gene test kit was authorized by the FDA on Wednesday. It is indicated for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasal aspirates, nasal washes, and bronchoalveolar lavage fluid from individuals suspected of COVID-19 by their healthcare provider.
The test kit is for use in high-complexity labs. It contains 120 tests to detect the SARS‑CoV‑2 genome in a triplex reaction, with detection of the N gene and RdRp gene of SARS‑CoV‑2, and internal control. It also contains 30 triplex pan-SARS tests to detect the E gene of Sarbecovirus, as well as a cellular and an internal control.
The kit is validated for extraction with the BioMérieux EMAG or NucliSENS easyMAG, the Qiagen QIASymphony SP, or the Roche MagNA Pure 96.
For thermal cycling, it is validated on the Applied Biosystems 7500 Fast and 7500 Fast Dx, the QuantStudio 5 Dx, the Roche LightCycler 480, the Bio-Rad Laboratories CFX96, and the Qiagen Rotor‑Gene Q.
The firm also received US EUA this week for a syndromic panel test, the BioMérieux BioFire Respiratory Panel 2.1, which detects SARS-CoV-2 and 20 other viral and bacterial respiratory pathogens in 45 minutes.