SML Genetree’s SARS-CoV-2 test receives FDA EUA

April 29, 2021

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.

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