Detection of in vivo hepatitis B virus surface antigen mutations—A comparison of four routine screening assays

摘要

Summary An important requirement for a state‐of‐the‐art hepatitis B surface antigen ( HB sAg) screening assay is reliable detection of mutated HB sAg. Currently, there is a striking shortage of data regarding the detection rates of in vivo HB sAg mutations for these clinically important assays. Therefore, we compared the detection rates of four commercial HB sAg screening assays using a global cohort of 1553 patients from four continents with known HBV genotypes. These samples, which represent the broadest spectrum of known and novel HB sAg major hydrophilic region ( MHR ) mutations to date, were analyzed for the presence of HB sAg using the Roche Elecsys ? HB sAg II Qualitative, Siemens ADVIA Centaur XP HB sAg II , Abbott Architect HB sAg Qualitative II and DiaSorin Liaison ? HB sAg Qualitative assays, respectively. Of the 1553 samples, 1391 samples could be sequenced; of these, 1013 (72.8%) carried at least one of the 345 currently known amino acid substitutions (distinct HB sAg mutation) in the HB sAg MHR . All 1553 patient samples were positive for HB sAg using the Elecsys ? HB sAg II Qual assay, with a sensitivity (95% confidence interval) of 99.94% (99.64%‐100%), followed by the Abbott Architect 99.81% (99.44%‐99.96%), Siemens ADVIA 99.81% (99.44%‐99.96%) and DiaSorin Liaison ? 99.36% (98.82%‐99.69%) assays, respectively. Our results indicate that the Elecsys ? HB sAg II Qual assay exhibits the highest sensitivity among the commercial HBsAg screening assays, and demonstrate that its capacity to detect HBV infection is not compromised by HB sAg MHR mutants.