NEW YORK — The US Food and Drug Administration on Thursday granted separate Emergency Use Authorizations (EUAs) for PCR-based SARS-CoV-2 tests developed by South Korean diagnostic test makers BioCore, SolGent, and Seasun Biomaterials.
The BioCore 2019-nCoV Real Time PCR Kit is designed to detect the SARS-CoV-2 N and RdRp genes in upper and lower respiratory specimens including nasopharyngeal swabs, sputum, and bronchoalveolar lavage.
SolGent's DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit is designed to detect the SARS-CoV-2 N gene and Orf1a in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasal aspirates, nasal washes, bronchoalveolar lavage, and sputum. The company received CE marking for the kit in March.
Seasun's AQ-TOP COVID-19 Rapid Detection Kit is based on real-time loop-mediated isothermal amplification and is designed to detect SARS-CoV-2 Orf1ab in upper and lower respiratory specimens including oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, and bronchoalveolar lavage and sputum. Seasun received EUA for its PCR-based U-TOP COVID-19 Detection Kit in April.
All three kits run on authorized PCR instruments and may be performed by any laboratory CLIA-certified to perform high-complexity tests, according to the FDA.