SD Biosensor Coronavirus PCR Test Receives FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 24 Apr 2020

SD Biosensor, INC. (Suwon, Gyungido, Korea) has secured EUA (Emergency Use Authorization) from the US FDA for its STANDARD M nCoV Real-Time Detection Kit. The kit is used for rapid identification and detection of novel coronavirus (2019-nCoV) nucleic acids in human nasopharyngeal swabs and throat swab samples. With the approval, SD BIOSENSOR has the authority to supply STANDARD M nCoV Real-Time Detection Kit across the US.

The STANDARD M nCoV Real-Time Detection kit is authorized for use on respiratory specimens collected from individuals who are suspected of COVID-19 by their healthcare provider. It has been designed according to “WHO interim guidance for laboratory testing for 2019 novel coronavirus (2019-nCoV) in humans." The STANDARD M nCoV Real-Time Detection kit can be used to test in nasopharyngeal, oropharyngeal, nasal, and mid-turbinate nasal swab specimens, and sputum. The RT-PCR test amplifies and diagnoses a specific gene sequence of COVID-19. It offers a one tube reaction for identification and detection of 2019-nCoV and includes all the reagents required for PCR. The test also includes nCoV primers/probes ORF1ab (RdRp) gene, E gene, as well as internal controls.