Department of Pathology & Microbiology, University of Nebraska Medical Center, 42nd and Emile Str., Omaha, NE 68198-5900, USA.
J Clin Virol. 2010 Aug;48(4):234-8. doi: 10.1016/j.jcv.2010.06.001. Epub 2010 Jun 26.
In April 2009, the United States Secretary of the Department of Health and Human Services declared a public health emergency concerning the 2009 influenza H1N1 outbreak. This declaration allowed the FDA to issue Emergency Use Authorization (EUA) of approved in vitro diagnostics to detect the 2009 influenza H1N1 in clinical specimens.
This report outlines the validation testing of the Cepheid Xpert Flu A Panel for the qualitative detection of 2009 H1N1 viral RNA.
This study was a multi-site, dual-method clinical evaluation comparing the results of testing between the Xpert Panel assay to the FDA-cleared Luminex Molecular Diagnostics xTAG Respiratory Viral Panel (Luminex RVP) assay and the EUA-granted Focus Diagnostics Influenza A/H1N1 (2009) Real Time RT-PCR (Focus H1N1) assay.
When compared to Luminex RVP (n=300) for influenza A detection, the Xpert Panel had a sensitivity of 91.2% (95% CI: 85.1-95.4), specificity of 99.4% (95% CI: 96.7-100), positive predictive value (PPV) of 99.2% (95% CI: 95.6-100), and a negative predictive value (NPV) of 93.1% (95% CI: 88.3-96.4). When compared to the Focus H1N1 (n=258) for detection of H1N1, the Xpert Panel had a sensitivity of 92.1% (95% CI: 82.4-97.4), specificity of 100% (95% CI: 98.5-100), PPV of 100% (95% CI: 95.0-100), and a NPV of 97.5% (95% CI: 94.3-99.2).
The results show the Cepheid Xpert Flu A Panel to be comparable to both the Luminex RVP and the Focus H1N1 assays. The Cepheid Xpert Panel was granted an EUA on 24 Dec 2009.
2009 年 4 月，美国卫生与公众服务部部长宣布 2009 年甲型 H1N1 流感爆发为公共卫生紧急事件。这一声明允许 FDA 发布紧急使用授权（EUA），批准用于检测临床标本中 2009 年甲型 H1N1 流感的体外诊断试剂。
本报告概述了 Cepheid Xpert Flu A 检测试剂盒用于定性检测 2009 年 H1N1 病毒 RNA 的验证测试。
本研究是一项多中心、双方法临床评估，比较 Xpert 检测试剂盒与经 FDA 批准的 Luminex Molecular Diagnostics xTAG 呼吸道病毒检测试剂盒（Luminex RVP）和 EUA 授权的 Focus Diagnostics 流感 A/H1N1（2009）实时 RT-PCR（Focus H1N1）检测试剂盒的检测结果。
与 Luminex RVP（n=300）用于流感 A 检测相比，Xpert 检测试剂盒的敏感性为 91.2%（95%CI：85.1-95.4），特异性为 99.4%（95%CI：96.7-100），阳性预测值（PPV）为 99.2%（95%CI：95.6-100），阴性预测值（NPV）为 93.1%（95%CI：88.3-96.4）。与 Focus H1N1（n=258）用于检测 H1N1 相比，Xpert 检测试剂盒的敏感性为 92.1%（95%CI：82.4-97.4），特异性为 100%（95%CI：98.5-100），PPV 为 100%（95%CI：95.0-100），NPV 为 97.5%（95%CI：94.3-99.2）。
结果表明 Cepheid Xpert Flu A 检测试剂盒与 Luminex RVP 和 Focus H1N1 检测试剂盒相当。Cepheid Xpert 检测试剂盒于 2009 年 12 月 24 日获得 EUA。
