Sensitivities of CE-Marked HIV, HCV, and HBsAg assays

The use of highly sensitive HIV, HBsAg and HCV screening assays is crucial for efficiently avoiding transfusion transmitted infections. Current harmonised regulatory requirements in the European Union (EU) demand state-of-the-art performance during seroconversion. Therefore, a representative number of European HIV, HCV and HBsAg immunoassays were compared using 30 commercially available seroconversion panels. The analytical sensitivity of HBsAg assays was determined using the second International Hepatitis B Surface Antigen (HBsAg) standard. The overall performance level of blood screening assays seems to be preserved since the last re-evaluation under the national provisions in Germany. Concerning HIV, recent progress has been achieved by the development of several highly sensitive HIV antigen/antibody (Ag/Ab) combination assays that further shorten the diagnostic window period. With respect to HCV, two HCV Ag/Ab combination tests have been introduced resulting in an enhancement of early detection. For HBsAg tests an overall significant improvement was not observed during the last 10 years. In contrast a few anti-HIV, HBsAg and anti-HCV assays have been CE-marked that represent a drastic step backwards. In conclusion, progress has been made for HIV and HCV that further augments the safety of blood donations. Nonetheless, there are apparent discrepancies in defining the state-of-the art by different EU member states resulting in the certification of assays with reduced performance. Attempts to define a common minimum standard in the EU are urgently needed.