NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for SML Genetree's Ezplex SARS-CoV-2 G Kit.
The PCR-based test is designed to detect the SARS-CoV-2 RdRP and N genes in nasopharyngeal swabs, oropharyngeal swabs, and sputum specimens. It is also authorized for pooled testing with up to five individual nasopharyngeal or oropharyngeal swabs collected in vials containing transport media.