Snibe becomes the 1st in China who receives Anti-HCV CLIA Assays List A CE Mark

Release Date:2019-07-26

July 2019, with the approval of CE mark for Anti-HCV CLIA assay, Snibe has become the 1st company in China to receive CE List A certification for Hepatitis C testing kit In CLIA field.  CE marking is required before reagent kits can be sold in the European market; this approval proves Snibe Anti-HCV Assay has totally met EU performance standards.



According to the World Health Organization, hepatitis C virus affects approximately 200 million people globally and mostly affected patients evolve to cirrhosis, liver failure and hepatocellular carcinoma. In the new era of antiviral HCV therapies, Anti-HCV Assay plays an important role in early diagnosis and treatment monitoring in HCV infection.

 

Snibe MAGLUMI Anti-HCV Assay was developed independently and have obtained patent in 2015. Compared with major manufactures, MAGLUMI Anti-HCV reagent which is featuring the latest and unique improved double antigen sandwich method and gene fusion expression technique could not only identify NS3 and NS4 antibodies but also detect NS5, which significantly increase the sensitivity, accuracy and reliability.

 


Figure2. The RNA genome of hepatitis C virus (HCV) is translated into proteins





The validation experiment which carried out by a German third-party independent laboratory shows that the seroconversion panels detection sensitivity of Snibe MAGLUMI Anti-HCV are superior to some major manufacturers.


As one of the global pioneers in IVD field, receiving the CE List A certificate of Anti-HCV is just the first step.Snibe have always been dedicated to pursuing high quality of our products and regarded it as the foundation of entrepreneur.More high-quality MAGLUMI Assays for infectious disease are continuing to get CE List A certification and more good news is coming soon.

 
Snibe, as the first CLIA manufacturer who got FDA cleared in China, has focused on the research of immunoassay product for 24 years.  Now its CLIA system has served more than 144 countries globally and has been installed more than 11000 units. The perspective for Snibe is to be the pioneer in global diagnosis field.