Snibe received the CE certificate (List A) for MAGLUMI^® HBsAg (CLIA) assay On March 11, 2022. It further proves the high reliability of the quality and performance of Snibe products, as well as a verification of Snibe’s leading position in the field of chemiluminescence.  

CE certificate (List A) is the highest level of CE certification, which is all processed by the German third-party laboratory with extremely strict quality requirements, and is transparent in the whole certification process. After the certification, there is also a stringent batch-batch testing procedure carried out by the Paul-Ehrlich-Institute (PEI) of the Agency of the German Federal Ministry of Health. In this rigorous clinical validation, MAGLUMI^® HBsAg (CLIA) assay still remained excellent clinical performance, with 99.9% in specificity and up to 100% in sensitivity. 

CE certificate (List A) for MAGLUMI^® HBsAg (CLIA) assay

Hepatitis B surface antigen (HBsAg) is one of the 4 essential WHO-recommended bio-markers for blood transfusion screening recommended by WHO. As blood transfusion is a significant component of health services, whereas inadequately tested blood donations put recipients at an increased risk of life-threatening transfusion-transmitted infections. In this case, WHO recommends that HIV antigen-antibody, HBsAg, HCV antigen-antibody, and Syphilis antibodies be priority essential bio-markers for blood transfusion. 

Snibe receiving CE certificate (List A) for MAGLUMI^® HBsAg (CLIA) assay fulfills the authoritative vacancy of our blood screening program. And now, all the 4 WHO-recommended bio-markers for blood transfusion screening are available on MAGLUMI^® panel with all CE-marked, which marks our further improvement of blood screening program and shows our concern for public health.

CE Certifications for MAGLUMI^® HIV Ab/Ag Combi CLIA assay, Anti-HCV CLIA assay, and Syphilis CLIA assay