Tag Archives: SML Genetree Sciences

July 2021—The SML Genetree Sciences’ Ezplex SARS-CoV-2 G Kit has been granted FDA emergency use authorization. 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. The test can also be used for up to five pooled individual nasopharyngeal or oropharyngeal swabs. Testing of the FDA SARS-COV-2 Reference Panel showed a detection limit of 1,200 NAAT detectable units (NDU)/mL.