Shanghai Fosun Pharmaceutical (Fosun Pharma) has secured emergency use authorisation from the US Food and Drug Administration (FDA) for its COVID-19 RT-PCR detection kit.
Fosun Pharma wholly-owned subsidiary Fosun Long March has developed the COVID-19 RT-PCR detection kit, which already secured the medical device registration certificate from the China National Medical Products Administration (NMPA), as well as CE mark approval from the European Union (EU).
The company’s kit facilitates the qualitative detection of novel coronavirus RNA by targeting the specific ORF1ab, N and E gene.
The COVID-19 RT-PCR kit holds the capacity to detect 96 samples within two hours
By applying fast automatic nucleic acid extraction instrument and extraction reagents, the test can detect 96 samples within two hours.
Automated testing will minimise the risk of operator infection and decrease the probability of cross-contamination in the clinical laboratory.
Since 1994, Fosun Pharma has been involved in the business of PCR hepatitis B virus diagnostic reagents,
Fosun Pharma’s medical diagnosis product portfolio is comprised of biochemical diagnosis, immune diagnosis, molecular diagnosis, and microbial diagnosis, POCT and mass spectrometry, as well as third-party detection service products.
The company’s business is said to cover the complete healthcare industry chain, including pharmaceutical manufacturing and R&D segment, medical devices, and diagnosis, healthcare services, as well as pharmaceutical distribution and retail.
Recently, the FDA has granted EUA status for saliva-based COVID-19 test. The EUA status allows the immediate use of saliva in COVID-19 testing exclusively applying the Spectrum SDNA-1000 saliva collection device, which enables to protect and preserve RNA used to detect infection.
