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.
The test has been validated for use on Bio-Rad Laboratories' CFX96 instrument and Thermo Fisher Scientific's Applied Biosystems 7500 RT-PCR system. Results are available within about two and a half hours following RNA extraction, according to Seoul, South Korea-based SML Genetree.
The test may be used by any lab CLIA-certified to perform high-complexity tests, the FDA said.