NEW YORK ─ The US Food and Drug Administration has granted Emergency Use Authorization to Shanghai Fosun Pharmaceutical for its COVID-19 RT-PCR detection kit and Osang Healthcare for its GeneFinder COVID-19 Plus RealAmp Kit.
Fosun Pharma's detection kit, developed by its subsidiary Fosun Long March, detects SARS-CoV-2 RNA targeting the ORF1ab, N, and E genes. The kit, which can test 96 samples within two hours, enables automated testing that lowers the risk of operator infection, reduces the probability of cross contamination in the clinical laboratory, and improves detection efficiency, Fosun Pharma said.
The kit has received a medical device registration certificate from the China National Medical Products Administration (NMPA) and CE certification that enables its marketing in Europe and other countries accepting the designation.
South Korea-based Osang Healthcare's GeneFinder COVID-19 Plus RealAmp Kit detects SARS-CoV-2 nucleic acids in nasopharyngeal, oropharyngeal, nasal, and mid-turbinate nasal swab specimens, as well as in bronchoalveolar lavage fluid and sputum. EliTechGroup MDx, the US arm of the global EliTechGroup, is the exclusive distributor of the test kits in certain markets in the US.