Beijing Center for Disease Prevention and Control, Beijing 100013, China.
J Virol Methods. 2013 Mar;188(1-2):25-8. doi: 10.1016/j.jviromet.2012.11.042. Epub 2012 Dec 7.
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).
甲型 H1N1 流感（pH1N1）的主动监测和诊断在中国流感大流行的有效控制和预防中发挥了关键作用。尽管北京的诊断实验室已经使用了几种市售的用于检测 pH1N1 病毒的实时 PCR 试剂盒，但对于这些试剂盒检测 pH1N1 病毒的性能却知之甚少。在本研究中，评估了北京的两种商业实时 PCR 试剂盒的性能。对临床样本的分析表明，AgPath-ID™试剂盒（38.2%）的阳性检出率明显高于大安 H1N1 试剂盒（30.0%）（McNemar 卡方检验，P=0.000）。AgPath-ID™试剂盒的检测限（LOD）分别为 10(2)、10(2)和 10(3)拷贝/反应，用于检测甲型流感（集 1）、H1N1 甲型流感（集 2）和 H1N1 甲型流感亚系 H1（集 3）基因，而大安试剂盒的 H1 和 N1 基因的 LOD 均为 10(3)拷贝/反应。尽管 AgPath-ID™试剂盒对 pH1N1 的检测率明显高于大安试剂盒，但 AgPath-ID™试剂盒在检测 H1N1 甲型流感（集 2）时对 A/PR8/34 存在交叉反应。
