Motte Anne, Colson Philippe, Tamalet Catherine
Laboratoire de Virologie, Centre Hospitalo-Universitaire Timone et CNRS UMR 6020 IFR48, Université de la Méditerranée, Marseille, France.
J Clin Virol. 2006 Nov;37(3):213-7. doi: 10.1016/j.jcv.2006.08.004. Epub 2006 Sep 28.
Hepatitis B virus (HBV) surface antibodies (anti-HBs) testing is useful in various clinical circumstances, including identification of HBV susceptible individuals in pre- and post-vaccination programs.
To assess the clinical performance of Beckman Coulter's anti-HBs chemiluminescence immunoassay (Access AbHBsII).
Laboratory performances were evaluated on 1207 routine samples pre-screened with Abbott Axsym anti-HBs assay and divided into three different panels: vaccinated subjects (n=232), subjects with resolved HBV infection (n=150) and negative subjects for anti-HBs (n=825). Sera with discrepant results were resolved by an alternative method and further chart review.
The overall concordance between Access and Axsym assays was 95.8%. The relative sensitivity, relative specificity, positive predictive value and negative predictive value were 97.8%, 98.1%, 96%, and 99%, respectively. Of the 51 discrepant results, eight were false negative by Access, fifteen were false positive by Access, including sera from seven pregnant women, two patients with acute leukemia, and four with inflammatory syndromes.
The Beckman Coulter's Access AbHBsII assay displays satisfactory relative sensitivity and specificity performances. The assay has good precision and reliability and is technically simple and fast.
乙肝病毒（HBV）表面抗体（抗-HBs）检测在多种临床情况下都很有用，包括在疫苗接种前后程序中识别HBV易感个体。
评估贝克曼库尔特公司的抗-HBs化学发光免疫分析（Access AbHBsII）的临床性能。
对1207份用雅培Axsym抗-HBs检测预先筛选的常规样本进行实验室性能评估，并将其分为三个不同组：接种疫苗的受试者（n = 232）、HBV感染已痊愈的受试者（n = 150）和抗-HBs阴性受试者（n = 825）。结果不一致的血清通过另一种方法和进一步的病历审查来解决。
Access和Axsym检测之间的总体一致性为95.8%。相对灵敏度、相对特异性、阳性预测值和阴性预测值分别为97.8%、98.1%、96%和99%。在51个不一致的结果中，Access有8例假阴性，15例假阳性，包括7名孕妇、2名急性白血病患者和4名患有炎症综合征患者的血清。
贝克曼库尔特公司的Access AbHBsII检测显示出令人满意的相对灵敏度和特异性性能。该检测具有良好的精密度和可靠性，技术操作简单且快速。
