The SML Genetree Ezplex SARS-CoV-2 G Kit has been granted emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA), according to a news release from SML Genetree Sciences.
This is a real-time PCR in vitro diagnostic test for the qualitative detection of nucleic acid for SARS-CoV-2 RdRp and N genes from nasopharyngeal and oropharyngeal swabs and sputum specimens. This test can also be used for up to 5 pooled individual nasopharyngeal or oropharyngeal swabs.
Testing of the FDA SARS-COV-2 Reference Panel showed a detection limit of 1200 NAAT.
