NEW YORK — The US Food and Drug Administration on Wednesday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Altona Diagnostics and Diatherix Eurofins.
Altona's RealStar SARS-CoV-2 RT-PCR Kit US is designed to detect viral nucleic acid in nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, and nasal aspirates. It runs on any authorized RT-PCR instrument and may be performed by labs CLIA-certified for high-complexity testing.