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首页> 外文期刊>Journal of Clinical Microbiology >Analytical Performance Determination and Clinical Validation of the Novel Roche RealTime Ready Influenza A/H1N1 Detection Set
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Analytical Performance Determination and Clinical Validation of the Novel Roche RealTime Ready Influenza A/H1N1 Detection Set

机译：新型罗氏实时就绪流感A / H1N1检测集的分析性能测定和临床验证

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The emergence of a novel pandemic human strain of influenza A (H1N1/09) virus in April 2009 has demonstrated the need for well-validated diagnostic tests that are broadly applicable, rapid, sensitive, and specific. The analytical performance and clinical validity of results generated with the novel Roche RealTime Ready Influenza A/H1N1 Detection Set using the LightCycler 2.0 instrument were characterized. Analytical performance was assessed by processing respiratory samples spiked with H1N1/09 and seasonal influenza A virus, a set of seasonal influenza A virus subtypes, and samples containing common viral and bacterial respiratory pathogens. The clinical validity of results was assessed in comparison to other assays by analyzing 359 specimens at three clinical sites and one reference laboratory. Direct sequencing was used to resolve samples with discrepant results. The assay detected virus concentrations down to <50 RNA copies per reverse transcription (RT)-quantitative PCR (qPCR). Various influenza A virus subtypes were covered. The analytical specificity was 100%. High clinical validity was demonstrated by the 99% positive agreement between seasonal influenza A viruses, 98% positive agreement between H1N1/09 viruses, and 88% agreement between negative results. The analytical sensitivity was compared to those of three other RT-qPCR assays and was found to be equivalent. The novel Roche RealTime Ready Influenza A/H1N1 Detection Set can be utilized on the widely used LightCycler platform. We demonstrate its usefulness for the rapid detection and surveillance of pandemic H1N1/09 influenza A virus infections.
机译：2009年4月出现了一种新型的大流行性人类A型流感病毒（H1N1 / 09），这表明需要经过广泛验证，快速，灵敏和特异的经过验证的诊断测试。表征了使用LightCycler 2.0仪器通过新型Roche RealTime Ready流感A / H1N1检测仪产生的结果的分析性能和临床有效性。通过处理掺有H1N1 / 09和季节性A型流感病毒，一组季节性A型流感病毒亚型的呼吸道样品以及含有常见病毒和细菌性呼吸道病原体的样品来评估分析性能。通过在三个临床地点和一个参考实验室分析359个标本，与其他分析相比，评估了结果的临床有效性。直接测序用于解析结果不一致的样品。该测定法检测到每个反转录（RT）定量PCR（qPCR）的病毒浓度低至<50 RNA拷贝。涵盖了各种甲型流感病毒亚型。分析特异性为100％。季节性A型流感病毒之间99％的阳性一致性，H1N1 / 09病毒之间的98％阳性一致性和阴性结果之间的88％一致性证明了较高的临床有效性。将分析灵敏度与其他三种RT-qPCR分析的灵敏度进行了比较，发现灵敏度相同。新型Roche RealTime Ready流感A / H1N1检测套件可在广泛使用的LightCycler平台上使用。我们证明了其对大流行H1N1 / 09甲型流感病毒感染的快速检测和监视的有用性。

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