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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
At present, Snibe’s products have been exported to more than 146 countries, with more than 19000 installations globally. Snibe as one of the global pioneers in IVD field, always persists in the spirit of "Quality is our life". In the future, Snibe will continue to innovate and seek breakthroughs, for more international authoritative certifications of MAGLUMI® products coming soon.
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