Head‐to‐head comparison between two screening systems for HBsAG, anti‐HBc, anti‐HCV and HIV combination immunoassays in an international, multicentre evaluation study

Background Mandatory screening of blood donations for hepatitis B and hepatitis C viruses and human immunodeficiency viruses 1 and 2 requires assays with exceptional sensitivity and specificity. This study reports the results from a direct head-to-head comparison of the Elecsys HBsAG II, Elecsys Anti-HBc, Elecsys Anti-HCV II and Elecsys HIV combi PT immunoassays with the respective ABBOTT PRISM/Architect instrument immunoassays in a multicentre blood bank evaluation study. Study Design and Methods Assay validation was performed in the blood screening laboratories of four blood bank centres in Austria, Germany, Spain and Thailand, where both first-time donor samples (approximately 6000 donors) and repeat donor samples (approximately 14 000 donors) were screened. Results Of all screened donor samples, 93 (0·46%) were confirmed to be positive using assays from both manufacturers. The specificity of all immunoassays was >99·5% and was comparable between first-time and multiple-time donors. A direct comparison between the assays from Roche and ABBOTT according to Bland and Altman analysis demonstrated equivalent quality. Conclusions These results suggest that the Elecsys immunoassays for HBV, HCV and HIV infection, with a comparative sensitivity of 100% and a specificity exceeding the common technical specification threshold of >99·5%, meet the stringent performance criteria stipulated for blood donor screening for these infectious agents. Significant differences in the specificity between first-time and repeat donors were not detectable.