Performance of the DiaSorin LIAISON® anti-HBs II for the detection of hepatitis B surface antibodies: Comparison with the Abbott Architect anti-HBs assay

Background: Detection of hepatitis B virus (HBV) surface antibodies (anti-HBs) is required in order to evaluate the response to hepatitis B vaccination and to optimize post-exposure monitoring. The widespread use of vaccines has highlighted the need for accurate and consistent quantification, yielding comparable quantitative results. Objectives: This study assessed the adequacy of DiaSorin LIAISON (R) anti-HBs II assay in detecting anti-HBs antibodies and determined the correlation with Abbott Architect anti-HBs quantification. Study design: Anti-HBs levels were measured in parallel using Abbott and DiaSorin kits on WHO international standard dilutions and 350 routine samples pre-screened with Abbott Architect anti-HBs. Three different serological panels were tested: vaccinated subjects (n = 121); subjects with past HBV infection (n = 109); and subjects with no HBV infection marker (n = 69). Serial dilutions from nine high-titer anti-HBs samples were used to address linearity. Results: Anti-HBs concentration measured on WHO standard dilutions indicated a good calibration of DiaSorin values against international units, while results for Abbott were below those expected. A strong impact of the dilution matrix used was observed when performing dilutions on high-titer samples. Despite difference in absolute quantification, the overall clinical agreement between the two assays was 96.9%, with strong correlation (r = 0.92) between concentrations and good linearity over the quantification range. Conclusions: The DiaSorin LIAISON (R) anti-HBs II assay shows excellent standardization to the WHO standard and good linearity. The assay is suitable for current clinical laboratory practice. (C) 2011 Elsevier B.V. All rights reserved.