Virology Laboratory, Hôpital Pitié-Salpêtrière, Assistance Publique (APHP), and ER 1 Pierre et Marie Curie University, Paris 6, France.
J Clin Virol. 2011 Apr;50(4):297-302. doi: 10.1016/j.jcv.2011.01.009. Epub 2011 Feb 16.
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.
This study assessed the adequacy of DiaSorin LIAISON(®) anti-HBs II assay in detecting anti-HBs antibodies and determined the correlation with Abbott Architect anti-HBs quantification.
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.
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.
The DiaSorin LIAISON(®) anti-HBs II assay shows excellent standardization to the WHO standard and good linearity. The assay is suitable for current clinical laboratory practice.
为了评估乙型肝炎病毒（HBV）表面抗体（抗-HBs）的反应和优化暴露后监测，需要检测抗-HBs。疫苗的广泛使用凸显了准确和一致定量的必要性，以产生可比的定量结果。
本研究评估了 DiaSorin LIAISON（®）抗-HBs II 检测抗-HBs 抗体的充分性，并确定了与 Abbott Architect 抗-HBs 定量的相关性。
使用 Abbott 和 DiaSorin 试剂盒对 WHO 国际标准稀释液和 350 份 Abbott Architect 抗-HBs 预筛选的常规样本进行平行检测抗-HBs 水平。测试了三个不同的血清学面板：接种疫苗的受试者（n=121）；既往 HBV 感染的受试者（n=109）；和无 HBV 感染标志物的受试者（n=69）。使用来自九个高滴度抗-HBs 样本的系列稀释液来解决线性问题。
在 WHO 标准稀释液上测量的抗-HBs 浓度表明 DiaSorin 值与国际单位的校准良好，而 Abbott 的结果则低于预期。在对高滴度样本进行稀释时，观察到稀释基质的强烈影响。尽管绝对定量存在差异，但两种检测方法的总体临床一致性为 96.9%，浓度之间具有强烈相关性（r=0.92），并且在定量范围内具有良好的线性度。
DiaSorin LIAISON（®）抗-HBs II 检测法与 WHO 标准具有出色的标准化和良好的线性度。该检测法适合当前临床实验室实践。
