Weber Bernard, Van der Taelem-Brulé Natacha, Berger Annemarie, Simon François, Geudin Marie, Ritter Jaques
Laboratoires Réunis, Junglinster, Luxembourg, Germany.
J Virol Methods. 2006 Jul;135(1):109-17. doi: 10.1016/j.jviromet.2006.02.009. Epub 2006 Mar 29.
In a multicenter study a new automated screening assay, VIDAS HBsAg Ultra (long (L) and short (S) incubation protocol (Biomérieux, Marcy l'Etoile, France), was compared to a well established test (AxSYM HBsAg v2, Abbott Diagnostics, Wiesbaden, Germany) for the detection of hepatitis B virus (HBV) surface antigen (HBsAg). A total of 32 seroconversion panels, sera from the chronic phase of infection, dilution series of the WHO standard, S gene mutants (recombinant mutants and diluted and undiluted sera harbouring mutants with single or multiple amino acid (aa) substitutions, n = 40) and isolated anti-HBc positive samples were tested for the evaluation of sensitivity. Sera from HBsAg negative blood donors, pregnant women, hospitalized patients and potentially cross-reactive samples were investigated to determine the specificity of the new assay. The VIDAS HBsAg Ultra (L+S) had a higher sensitivity than the alternative assay for the detection of acute hepatitis B in seroconversion panels. The mean time of the diagnostic window was shortened with the VIDAS HBsAg Ultra (L) and (S) in comparison with the AxSYM HBsAg v2 by 1.06 and 0.66 days, respectively. The VIDAS HBsAg Ultra (L) did not detect one diluted sample out of six bearing the single aa G145R substitution, and two out of 12 diluted samples harbouring multiple aa substitutions. The analytical sensitivity of the assays varied from one surface mutant to another. While no false positive results were obtained with the VIDAS HBsAg Ultra (L+S) among potentially interfering samples, four false positives were detected with the AxSYM HBsAg v2. The respective values for sensitivity for the VIDAS HBsAg Ultra (L), (S) and the AxSYM HBsAg v2 were 99.07%, 97.87% and 94.14%. The specificities were 100% (VIDAS HBsAg Ultra L and S) and 99.6% (AxSYM HBsAg v2). In conclusion, the VIDAS HBsAg Ultra is highly sensitive and specific and represents an improvement for the detection of HBsAg in routine diagnostic laboratories.
在一项多中心研究中，将一种新型自动化筛查检测方法VIDAS HBsAg Ultra（长（L）和短（S）孵育方案，法国马西耶图瓦勒生物梅里埃公司）与一种成熟的检测方法（AxSYM HBsAg v2，德国威斯巴登雅培诊断公司）进行比较，以检测乙型肝炎病毒（HBV）表面抗原（HBsAg）。共检测了32个血清转化样本组、感染慢性期的血清、世界卫生组织标准品的稀释系列、S基因突变体（重组突变体以及含有单个或多个氨基酸（aa）替换的突变体的稀释和未稀释血清，n = 40）以及分离出的抗-HBc阳性样本，以评估敏感性。检测了HBsAg阴性献血者、孕妇、住院患者的血清以及可能存在交叉反应的样本，以确定新检测方法的特异性。在血清转化样本组中，VIDAS HBsAg Ultra（L+S）检测急性乙型肝炎的敏感性高于对照检测方法。与AxSYM HBsAg v2相比，VIDAS HBsAg Ultra（L）和（S）的诊断窗口期平均时间分别缩短了1.06天和0.66天。VIDAS HBsAg Ultra（L）未检测出6个携带单个aa G145R替换的稀释样本中的1个，以及12个携带多个aa替换的稀释样本中的2个。不同表面突变体的检测方法分析敏感性有所不同。在可能产生干扰的样本中，VIDAS HBsAg Ultra（L+S）未获得假阳性结果，而AxSYM HBsAg v2检测到4例假阳性。VIDAS HBsAg Ultra（L）、（S）和AxSYM HBsAg v2的敏感性分别为99.07%、97.87%和94.14%。特异性分别为100%（VIDAS HBsAg Ultra L和S）和99.6%（AxSYM HBsAg v2）。总之，VIDAS HBsAg Ultra具有高度敏感性和特异性，代表了常规诊断实验室检测HBsAg的一项改进。
