Qingdao HuaRen Pharmaceutical Gains CE Marks for Monkeypox and COVID-19 Detection Kits

China-based Qingdao HuaRen Pharmaceutical Co., Ltd (SHE: 300110) has announced receiving CE marks in the European Union (EU) for its monkeypox virus nucleic acid detection kit (fluorescent PCR method) and novel coronavirus (SARS-CoV-2) antigen detection kit.

Monkeypox Virus Detection Kit
The monkeypox virus nucleic acid detection kit uses a real-time fluorescent PCR method to detect specific gene fragments of the monkeypox virus. It is designed for qualitative detection in serum or lesion exudate samples and is intended for use by clinical laboratories and healthcare professionals, not for self-testing.

COVID-19 Antigen Detection Kit
The novel coronavirus (SARS-CoV-2) antigen detection kit employs immunochromatography and the double antibody sandwich method to qualitatively detect the SARS-CoV-2 antigen in human nasopharyngeal or oropharyngeal swabs. This kit offers rapid, simple, accurate, and highly sensitive initial screening for viral infections and can be widely used in clinical systems, medical care institutions, and scientific research.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry