Evaluation of two commercial real-time PCR kits for detection of pandemic (H1N1) 2009 virus in Beijing.

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).
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