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首页> 外文期刊>Medical Microbiology and Immunology >Multicenter study of a new fully automated HBsAg screening assay with enhanced sensitivity for the detection of HBV mutants
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Multicenter study of a new fully automated HBsAg screening assay with enhanced sensitivity for the detection of HBV mutants

机译：多中心研究了一种新型的全自动HBsAg筛选检测方法，具有更高的检测HBV突变体的灵敏度

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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.
机译：在一项多中心研究中，将一种新型的全自动Roche Diagnostics Elecsys ®对HBsAg突变检测具有更高敏感性的HBsAg II筛查测定与公认的HBsAg测试进行了比较：AxSYM HBsAg V2（Abbott），建筑师HBsAg（ Abbott），Advia Centaur HBsAg（拜耳（Bayer））Enzygnost HBsAg 5.0（Dade-Behring）和Vitros Eci HBsAg（Ortho）。共有16个血清学转换样本，60个HBsAg天然突变体和31个HBsAg重组突变体，NIBSC和PEI标准品的稀释系列，156个A型至G型基因型HBV阳性样品，686个不同感染阶段的预选HBsAg阳性样品，3,593个测试了日常样本和6360种未经选择的献血，以评估分析和临床敏感性，突变体的检测以及新测定法的特异性。 Elecsys ® HBsAg II在血清转化面板中显示出比所比较的测试具有统计学上显着更好的敏感性。在60个天然突变体中，有57个突变体和所有重组突变体均为阳性。在156个不同基因型的HBV样本和696个预选的HBsAg阳性样本中，Elecsys ® HBsAg II的敏感性达到100％。计算得出NIBSC标准的下限为0.025 IU / ml，PEI标准的ad和ay分别为<0.001和<0.005 U / ml。在2,724例日常标本和6.360例未经选择的献血中，Elecsys ® HBsAg II的特异性分别为99.97和99.88％。总之，新的Elecsys HBsAg II对检测所有阶段的HBV感染和HBsAg突变体具有很高的灵敏度，并且在献血者，日常样本和潜在干扰血清中具有很高的特异性。

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