On May 26,2022, Snibe has received the CE List A Certificate for 5 MAGLUMI® CLIA immunoassays of Hepatitis B virus (HBV) detection, covering Anti-HBc IgM, Anti-HBs, HBeAg, Anti-HBe, and anti-HBC. Up to now, 6 CLIA immunoassays for HBV detection have all obtained CE List A Certificate, besides the MAGLUMI® HBsAg (CLIA) Assay.  

CE List A certificate is the highest level of CE certification. All clinical trials of certification are conducted in third-party laboratories in Germany which have extremely strict quality requirements and are open and transparent in the whole certification process. Meanwhile, the assays all adopt the direct chemiluminescence method, traceable to the international standard of the World Health Organization (WHO).

To realize the prevention and treatment of hepatitis B, it is necessary to carry out HBV screening and treatment early, control the infection root, and cut off the transmission route. Among them, serological detection is less invasive and easy to operate, thus becoming the main screening method. It plays a significant role in clinical practice, prevention, diagnosis, treatment, and prognostic evaluation of HBV, enabling it to provide more accurate, more comprehensive and more intuitive test results. 

Until now, 9 Key MAGLUMI® immunoassays for infectious disease with CE Certificate, and 8 out of which have CE List A certification including 6 assays for HBV detection, and 2 assays for HIV and HCV detection. The latest receiving CE List A certificate for Hepatitis B CLIA assays not only represents our constant focus on the quality of products, but also the perfection and support for HBV detection and infectious disease program.   

Snibe as one of the global pioneers in the IVD field always persists in the spirit of "Quality is our life". In the coming future, Snibe will continue to innovate and seek breakthroughs, and invite your witness for more international authoritative certifications of MAGLUMI® products.