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

:积极监测和诊断2009年H1N1流感大流行(pH1N1)在有效控制和预防中国大流行中发挥了关键作用。尽管北京的诊断实验室已经使用了几种针对pH1N1病毒的实时PCR试剂盒,但对于这些试剂盒检测pH1N1病毒的性能知之甚少。在这项研究中,评估了北京两种商业实时PCR试剂盒的性能。临床样品分析表明,AgPath-ID™试剂盒的阳性检出率(38.2%)大大高于大安H1N1试剂盒的检出率(30.0%)(McNemar卡方检验,P = 0.000)。对于甲型流感(第1组),甲型H1N1流感(第2组)和甲型流感(组1),AgPath-ID™试剂盒的检测限(LOD)为10(2),10(2)和10(3)拷贝/反应。 H1N1甲型流感亚H1(第3组)基因,而大安试剂盒的LOD对H1和N1基因均为10(3)拷贝/反应。尽管AgPath-ID™试剂盒对pH1N1的检测率比Da An试剂盒高得多,但发现针对H1N1甲型流感的AgPath-ID™试剂盒(组2)与A / PR8 / 34有交叉反应。

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