April 23, 2020—ELITechGroup MDx and its Korean partner, Osang Healthcare, announced that the FDA has issued emergency use authorization for Osang’s SARS-CoV-2 virus test for use in the United States.
The GeneFinder COVID-19 Plus RealAmp Kit provides a diagnostic solution to identify clusters of infection and has been validated using the Applied Biosystems 7500 thermocycler and Bio-Rad CFX96.
The highly sensitive testing kit requires a single tube, rather than multiple reactions, and uses alveolar fluid, throat swab, or sputum samples in a PCR instrument to detect the virus. Qualitative results are delivered within 4.5 hours.