Shanghai Fosun Pharmaceutical (Fosun Pharma) has been granted the emergency use authorization (EUA) status for its COVID-19 RT-PCR detection kit from the US Food and Drug Administration (FDA).
Fosun Long March, a fully-owned subsidiary of Fosun Pharma, developed the COVID-19 RT-PCR detection kit which already has a medical device registration certificate from the China National Medical Products Administration and also CE mark approval from the European Union.
The COVID-19 RT-PCR detection kit is said to have a capacity to detect 96 samples within two hours by applying fast automatic nucleic acid extraction instrument and extraction reagents. The risk of operator infection will be minimized with automated testing and also lowers the probability of cross-contamination in the clinical laboratory.
The kit is said to help in the qualitative detection of novel coronavirus RNA by targeting the particular ORF1ab, N, and E gene.
Fosun Pharma has been engaged in the business of PCR hepatitis B virus diagnostic reagents since 1994.
The company’s medical diagnosis product portfolio consists of biochemical diagnosis, immune diagnosis, microbial diagnosis and molecular diagnosis, POCT and mass spectrometry, and third party detection service products.
The company’s business covers the whole healthcare industry chain including pharmaceutical manufacturing and R&D segment, medical devices, and diagnosis, healthcare services, and pharmaceutical distribution and retail.