The test is equipped with high sensitivity and specificity, strong anti-interference ability and no cross-reactivity for easy operability and quick results in 15 minutes
Fosun Diagnostics’ novel coronavirus antigen detection kit received China NMPA Approval. (Credit: Fosun Pharma)
Shanghai-based Fosun Diagnostics announced that it received China’s National Medical Products Administration (NMPA) approval for the commercial and clinical use of its rapid antigen testing in COVID-19 screening.
Fosun Diagnostics, a subsidiary company of Fosun Pharma, developed the test based on in-vitro qualitative detection method of novel coronavirus (2019-nCoV) nucleocapsid antigen.
The novel coronavirus detection kit is developed to identify three targets (ORF1ab, N, and E genes) at the same time.
The tests uses nasopharyngeal swab samples from patients with respiratory and fever-related symptoms within 7 days and quarantine observers for the detection.
Fosun Diagnostics’ test is designed to provide for easy operability and quick results in 15 minutes. It is equipped with high sensitivity and specificity, strong anti-interference ability and no cross-reactivity.
To meet various testing requirements at the point of demand whenever needed, the test has a variety of reagents.
The product already has EU CE certification, BfArM registration in Germany, and is officially endorsed by the EU Health Security Committee Common List.
Fosun Diagnostics stated: “Lately, the State Council’s of China under the Joint Prevention & Control for novel coronavirus pneumonia has decided to include antigen detection as a key supplement to nucleic acid detection under the “New Coronavirus Antigen Detection Application Plan (Pilot Trial)”.
“Fosun Diagnostics’ Novel Coronavirus Antigen Detection Kit will contribute and continue serving the needs of pandemic prevention and control upon its recent approval.”
The firm’s test kits have also secured relevant approvals and certifications in the US, European Union, Australia and many other countries and regions.
For novel coronavirus nucleic acid testing, Fosun Diagnostics offers a complete solution including reagents, equipment, and consumables.