University of North Carolina Health Care System, Chapel Hill, North Carolina, USA.
J Clin Microbiol. 2013 May;51(5):1528-33. doi: 10.1128/JCM.03368-12. Epub 2013 Mar 13.
There are several U.S. FDA-cleared molecular respiratory virus panels available today, each with advantages and disadvantages. This study compares four multiplex panels, the BioFire Diagnostics FilmArray RP (respiratory panel), the GenMark Dx eSensor RVP (respiratory viral panel), the Luminex xTAG RVPv1, and the Luminex xTAG RVP fast. Three hundred specimens (200 retrospective and 100 consecutive) were tested using all four platforms to determine performance characteristics. The overall sensitivity and specificity, respectively, and 95% confidence interval (CI; in parentheses) for each panel were as follows: FilmArray RP, 84.5% (79.2, 88.6) and 100% (96.2, 100); eSensor RVP, 98.3% (95.5, 99.5) and 99.2% (95.4, 100); xTAG RVPv1, 92.7% (88.5, 95.4) and 99.8% (96.0, 100); and xTAG RVP fast, 84.4% (78.5, 88.9) and 99.9% (96.1, 100). The sensitivity of each assay fluctuated by viral target, with the greatest discrepancies noted for adenovirus and influenza virus B detection. Hands-on time and time to result were recorded and ease of use was assessed to generate a complete profile of each assay.
目前有几种获得美国食品和药物管理局批准的分子呼吸道病毒检测试剂盒，每种试剂盒都有其优缺点。本研究比较了四种多重检测试剂盒，即生物梅里埃诊断公司的 FilmArray RP（呼吸道检测试剂盒）、基因标记公司的 GenMark Dx eSensor RVP（呼吸道病毒检测试剂盒）、Luminex xTAG RVPv1 和 Luminex xTAG RVP fast。使用这四种平台对 300 份标本（200 份回顾性标本和 100 份连续标本）进行了检测，以确定各平台的性能特征。每个检测试剂盒的总体敏感性和特异性以及 95%置信区间（CI；括号内）分别为：FilmArray RP，84.5%（79.2，88.6）和 100%（96.2，100）；eSensor RVP，98.3%（95.5，99.5）和 99.2%（95.4，100）；xTAG RVPv1，92.7%（88.5，95.4）和 99.8%（96.0，100）；xTAG RVP fast，84.4%（78.5，88.9）和 99.9%（96.1，100）。每种检测方法的敏感性因病毒靶标而异，其中腺病毒和乙型流感病毒检测的差异最大。记录了实际操作时间和检测结果时间，并评估了易用性，以生成每个检测方法的完整概况。
