Active surveillance and diagnosis of the influenza pandemic (H1N1) 2009 (pH1N1) have played a critical role in the effective control and prevention of the pandemic in China. Although several commercially available real-time PCR kits for pH1N1 virus have been used in diagnostic laboratories in Beijing, little has been known about the performance of these kits for detecting pH1N1 virus. In this study, the performance of two commercial real-time PCR kits in Beijing was evaluated. Analysis of clinical samples showed that the positive detection rate for the AgPath-ID™ kit (38.2%) was significantly higher than that for the Da An H1N1 kit (30.0%) (McNemar's chi-square test, P=0.000). The limit of detection (LOD) of the AgPath-ID™ kit was 10(2), 10(2), and 10(3) copies/reaction for the Influenza A (set 1), H1N1 Influenza A (set 2) and H1N1 Influenza A Sub H1 (set 3) genes, respectively, whereas the LOD of the Da An kit was 10(3) copies/reaction for both H1 and N1 genes. Although the AgPath-ID™ kit exhibited a significantly higher detection rate for pH1N1 than the Da An kit, cross-reactivity to A/PR8/34 was found for the AgPath-ID™ kit for H1N1 Influenza A (set 2).

译文

对流感大流行 (H1N1) 2009 (pH1N1) 的积极监测和诊断在有效控制和预防中国大流行方面发挥了关键作用。尽管北京的诊断实验室已经使用了几种市售的pH1N1病毒实时PCR试剂盒,但对这些试剂盒检测pH1N1病毒的性能知之甚少。在这项研究中,评估了北京两种商用实时PCR试剂盒的性能。临床样本分析表明,AgPath-ID的阳性检出率™试剂盒 (38.2%) 显着高于Da H1N1试剂盒 (30.0%) (McNemar卡方检验,P = 0.000)。AgPath-ID的检测极限 (LOD)™试剂盒分别为甲型流感 (第1组) 、甲型H1N1流感 (第2组) 和甲型H1N1流感亚H1 (第3组) 基因的10(2) 、10(2) 和10(3) 拷贝/反应,而Da An试剂盒的LOD对于H1和N1基因均为10(3) 个拷贝/反应。虽然AgPath-ID™试剂盒对pH1N1的检出率明显高于Da一试剂盒,发现AgPath-ID对a/PR8/34的交叉反应性™甲型H1N1流感试剂盒 (第2套)。

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