Mühlbacher A, Weber B, Bürgisser P, Eiras A, Cabrera J, Louisirirotchanakul S, Tiller F-W, Kim H-S, v Helden J, Bossi V, Echevarria J-M
Universitätsklinik für Blutgruppenserologie und Transfusionsmedizin der Paracelsus Medizinischen Privatuniversität Salzburg, Salzburg, Austria.
Med Microbiol Immunol. 2008 Mar;197(1):55-64. doi: 10.1007/s00430-007-0059-9. Epub 2007 Sep 21.
In a multicenter study a new, fully automated Roche Diagnostics Elecsys HBsAg II screening assay with improved sensitivity to HBsAg mutant detection was compared to well-established HBsAg tests: AxSYM HBsAg V2 (Abbott), Architect HBsAg (Abbott), Advia Centaur HBsAg (Bayer) Enzygnost HBsAg 5.0 (Dade-Behring), and Vitros Eci HBsAg (Ortho). A total of 16 seroconversion panels, samples of 60 HBsAg native mutants, and 31 HBsAg recombinant mutants, dilution series of NIBSC and PEI standards, 156 HBV positive samples comprising genotypes A to G, 686 preselected HBsAg positive samples from different stages of infection, 3,593 samples from daily routine, and 6,360 unselected blood donations were tested to evaluate the analytical and clinical sensitivity, the detection of mutants, and the specificity of the new assay. Elecsys HBsAg II showed a statistically significant better sensitivity in seroconversion panels to the compared tests. Fifty-seven out of 60 native mutants and all recombinant mutants were found positive. Among 156 HBV samples with different genotypes and 696 preselected HBsAg positive samples Elecsys HBsAg II achieved a sensitivity of 100%. The lower detection limit for NIBSC standard was calculated to be 0.025 IU/ml and for the PEI standards ad and ay it was <0.001 and <0.005 U/ml, respectively. Within 2,724 daily routine specimens and 6.360 unselected blood donations Elecsys HBsAg II showed a specificity of 99.97 and 99.88%, respectively. In conclusion the new Elecsys HBsAg II shows a high sensitivity for the detection of all stages of HBV infection and HBsAg mutants paired together with a high specificity in blood donors, daily routine samples, and potentially interfering sera.
在一项多中心研究中，将一种新型的、对乙肝表面抗原（HBsAg）突变体检测具有更高灵敏度的全自动罗氏诊断公司Elecsys HBsAg II筛查检测法，与成熟的HBsAg检测法进行了比较：AxSYM HBsAg V2（雅培公司）、Architect HBsAg（雅培公司）、Advia Centaur HBsAg（拜耳公司）、Enzygnost HBsAg 5.0（达德-拜林公司）以及Vitros Eci HBsAg（奥索公司）。共检测了16个血清转化样本组、60个HBsAg天然突变体样本、31个HBsAg重组突变体样本、NIBSC和PEI标准品的稀释系列、156个包含A至G基因型的HBV阳性样本、686个从不同感染阶段预先选择的HBsAg阳性样本、3593个日常样本以及6360个未经选择的献血样本，以评估新检测法的分析和临床灵敏度、突变体检测能力以及特异性。与所比较的检测法相比，Elecsys HBsAg II在血清转化样本组中显示出统计学上显著更高的灵敏度。60个天然突变体中有57个以及所有重组突变体均被检测为阳性。在156个不同基因型的HBV样本和696个预先选择的HBsAg阳性样本中，Elecsys HBsAg II的灵敏度达到了100%。计算得出NIBSC标准品的最低检测限为0.025 IU/ml，PEI标准品ad和ay的最低检测限分别为<0.001和<0.005 U/ml。在2724个日常样本和6360个未经选择的献血样本中，Elecsys HBsAg II的特异性分别为99.97%和99.88%。总之，新型Elecsys HBsAg II对HBV感染的所有阶段以及HBsAg突变体的检测具有高灵敏度，同时在献血者、日常样本以及可能存在干扰的血清中具有高特异性。
