针对Access免疫分析系统系列的乙型肝炎表面抗原（HBsAg）检测及HBsAg确证检测的多中心评估
Multi-center evaluation of the hepatitis B surface antigen (HBsAg) assay and HbsAg confirmatory assay for the family of Access immunoassay systems.
作者信息
Lunel-Fabiani Françoise, Duburcq Xavier, Levayer Thierry, Descamps Frederique, Maniez-Montreuil Michele, Pivert Adeline, Ducancelle Alexandra, Pouzet Agnes, Marant Lydie, Clèment Anne, Duhamel David, Leirens Yannick, Margotteau Fanny, Falcou-Briatte Roselyne, Heinen Christine, Bouniort Fabrice, Taskar Suhas, Artus Alain, Woodrum David, Flecheux Odile
机构信息
Laboratoire de Virologie, CHU Angers, UFR Sciences Médicales, Angers, France.
出版信息
Clin Lab. 2010;56(7-8):281-90.
BACKGROUND
Accurate detection of Hepatitis B Surface Antigen (HBsAg) is an important aid in the diagnosis of patients infected with the hepatitis B virus (HBV). A multi-center study was conducted to characterize the performance of the HBsAg assay on the family of Access immunoassay systems from Beckman Coulter.
METHODS
The Access HBsAg assay was characterized in a multi-center study and compared to the Abbott AxSYM* and PRISM* HBsAg assays. The bioMérieux VIDAS* assay was used to resolve discrepant results. Reproducibility studies (intra-assay, inter-assay and inter-lot) were performed with pooled serum samples (negative sample, close to cut off, low, medium and high positive samples). Analytical sensitivity, subtype and genotype detection were studied with various commercial panels (SFTS panel, WHO 80/549, WHO 00/588, Teragenix HBV Genotype panel). A panel of recombinant HBsAg mutant proteins was tested to investigate reactivity towards genetic mutations. Clinical sensitivity was verified with seroconversion panels and samples from subjects with known HBV infection. Analytical specificity was studied with samples from patients with potential cross-reactive infections. Clinical specificity was validated among blood donors and a hospitalized population.
RESULTS
The imprecision was < 10%. Analytical sensitivity was < or = 0.1 ng/mL (SFTS panel), 0.020 PEI Units/mL (ad panel), 0.024 PEI Units/mL (ay panel), 0.092 IU/mL with WHO 80/549 and 0.056 IU/mL with WHO 00/588. All genotype samples and HBsAg mutants were reactive with the Access HBsAg assay. Seroconversion panels tested showed no significant difference with the reference method. Sensitivity for subjects with known HBV infection was 100%. No interference with potentially cross-reactive infections was observed after confirmatory testing. Specificity was 99.96% (100% after confirmatory testing) in a blood donor population and 99.5% (100% after confirmatory testing) in a hospitalized population. Excellent separation of positive and negative populations was observed.
CONCLUSIONS
The Access HBsAg and HBsAg Confirmatory assays meet all clinical and analytical performance requirements of assays for the detection of HBsAg.
背景
准确检测乙型肝炎表面抗原（HBsAg）对诊断乙型肝炎病毒（HBV）感染患者具有重要辅助作用。开展了一项多中心研究，以评估贝克曼库尔特公司Access免疫分析系统系列中HBsAg检测方法的性能。
方法
在一项多中心研究中对Access HBsAg检测方法进行评估，并与雅培AxSYM和PRISM HBsAg检测方法进行比较。使用生物梅里埃VIDAS*检测方法解决结果不一致的问题。采用混合血清样本（阴性样本、接近临界值样本、低、中、高阳性样本）进行重复性研究（批内、批间和批间）。使用各种商业检测板（SFTS检测板、WHO 80/549、WHO 00/588、Teragenix HBV基因型检测板）研究分析灵敏度、亚型和基因型检测。测试一组重组HBsAg突变蛋白，以研究对基因突变的反应性。通过血清转换检测板和已知HBV感染受试者的样本验证临床灵敏度。使用可能存在交叉反应性感染患者的样本研究分析特异性。在献血者和住院人群中验证临床特异性。
结果
不精密度<10%。分析灵敏度<或=0.1 ng/mL（SFTS检测板）、0.020国际单位/毫升（ad检测板）、0.024国际单位/毫升（ay检测板）、WHO 80/549为0.092 IU/mL，WHO 00/588为0.056 IU/mL。所有基因型样本和HBsAg突变体均与Access HBsAg检测方法反应。测试的血清转换检测板与参考方法无显著差异。已知HBV感染受试者的灵敏度为100%。确认检测后未观察到对潜在交叉反应性感染的干扰。献血人群中的特异性为99.96%（确认检测后为100%），住院人群中的特异性为99.5%（确认检测后为100%）。观察到阳性和阴性人群的良好分离。
结论
Access HBsAg和HBsAg确认检测方法满足检测HBsAg检测方法的所有临床和分析性能要求。
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