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首页> 外文期刊>Journal of Clinical Microbiology >Improved Detection of Hepatitis B Virus Surface Antigen by a New Rapid Automated Assay
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Improved Detection of Hepatitis B Virus Surface Antigen by a New Rapid Automated Assay

机译：新型快速自动检测方法改进了对乙型肝炎病毒表面抗原的检测

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The performance of hepatitis B virus (HBV) surface antigen (HBsAg) screening assays is continuously improved in order to reduce the residual risk of transfusion-associated hepatitis B. In a multicenter study, a new automated rapid screening assay, Elecsys HBsAg (Roche Diagnostics), was compared to well-established tests (Auszyme Monoclonal [overnight incubation] version B and IMx HBsAg [Abbott]). Included in the evaluation were 23 seroconversion panels; sera from the acute and chronic phases of infection; dilution series of various HBsAg standards, HBV subtypes, and S gene mutants; and isolated anti-HBV core antigen-positive samples. To challenge the specificity of the new assay, sera from HBsAg-negative blood donors, pregnant women, and dialysis and hospitalized patients and potentially cross-reactive samples were investigated. Elecsys HBsAg showed a higher sensitivity for HBsAg subtypes ad, ay, adw2, adw4, ayw1, ayw2, ayw4, and adr detection in dilution series of different standards or sera than Auszyme Monoclonal version B and/or IMx HBsAg. Acute hepatitis B was detected in 11 to 16 of 23 seroconversion panels between 2 and 16 days earlier with Elecsys HBsAg than with the alternative assays. Elecsys HBsAg and Auszyme Monoclonal version B detected HBsAg surface mutants with equal sensitivity. The sensitivity and specificity of Elecsys HBsAg were 100%. Auszyme Monoclonal version B had a 99.9% specificity, and its sensitivity was 96.6%. IMx HBsAg showed a poorer sensitivity and specificity than the other assays. In conclusion, Elecsys HBsAg permits earlier detection of acute hepatitis B and different HBV subtypes than the alternative assays. By using highly sensitive HBsAg screening assays, low-level HBsAg carriers among isolated anti-HBV core antigen-positive individuals can be detected.
机译：乙肝病毒（HBV）表面抗原（HBsAg）筛选试验的性能不断提高，以减少与输血相关的乙型肝炎的残留风险。在多中心研究中，一项新的自动快速筛选试验Elecsys HBsAg（Roche Diagnostics ）与公认的测试（Auszyme单克隆[过夜孵育] B型和IMx HBsAg [Abbott]）进行了比较。评估中包括23个血清转化小组;来自感染的急性和慢性阶段的血清;各种HBsAg标准品，HBV亚型和S基因突变体的稀释系列;和分离的抗HBV核心抗原阳性样品。为了挑战这种新方法的特异性，对HBsAg阴性献血者，孕妇，透析患者和住院患者的血清以及可能发生交叉反应的样本进行了调查。与Auszyme单克隆版本B和/或IMx HBsAg相比，Elecsys HBsAg对ad，ay，adw2，adw4，ayw1，ayw2，ayw4和adr检测的稀释液在不同标准或血清稀释系列中显示出更高的敏感性。与替代试验相比，使用Elecsys HBsAg在2至16天之前，在23个血清转换小组中的11至16个中检测到了急性乙型肝炎。 Elecsys HBsAg和Auszyme单克隆B型检测到的HBsAg表面突变体具有相同的敏感性。 Elecsys HBsAg的敏感性和特异性为100％。 B型Auszyme的特异性为99.9％，敏感性为96.6％。 IMx HBsAg的敏感性和特异性较其他测定差。总之，与其他方法相比，Elecsys HBsAg可以更早地检测出急性乙型肝炎和不同的HBV亚型。通过使用高度敏感的HBsAg筛选测定，可以检测出分离出的抗HBV核心抗原阳性个体中的低水平HBsAg携带者。

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