Department of Pathology, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555-0740, USA.
J Clin Microbiol. 2011 Dec;49(12):4083-8. doi: 10.1128/JCM.05010-11. Epub 2011 Oct 12.
We compared the diagnostic performance and overall respiratory pathogen detection rate of the premarket version of the FilmArray Respiratory Panel (RP) multiplex PCR assay (Idaho Technology, Inc., Salt Lake City, UT) with those of the Food and Drug Administration (FDA)-cleared Prodesse ProFlu+, ProFAST+, ProParaflu+, Pro hMPV+, and ProAdeno+ real-time PCR assays (Gen-Probe, San Diego, CA). The assays were performed on a panel of 192 nasopharyngeal-secretion specimens collected from 81 children under 1 year of age with upper respiratory tract symptoms. To resolve discordant results and confirm pathogens detected only by the larger FilmArray panel, we performed laboratory-developed real-time PCR assays. Among viruses detectable by both commercial assays (adenovirus, human metapneumovirus, influenza A virus, influenza B virus, parainfluenza viruses 1 to 3, and respiratory syncytial virus), the FilmArray and Prodesse assays showed good overall agreement (181/192 [94.3%]; kappa = 0.87; 95% CI, 0.79 to 0.94). FilmArray RP detected more parainfluenza viruses 1 and 3 than ProParaflu+ (18 versus 13) while ProAdeno+ detected more adenoviruses (11 versus 6), but these differences were not statistically significant. Additionally, FilmArray RP detected 138 pathogens (confirmed as true positives) not included in the Prodesse assays (rhinovirus [RV]/enterovirus [EV], 118; bocavirus, 8; coronavirus, 7; parainfluenza virus 4, 4; Mycoplasma pneumoniae, 1). FilmArray RP was cleared by the FDA following the completion of this study. The FDA-cleared version includes the following targets: adenovirus, coronaviruses HKU1 and NL63, human metapneumovirus (hMPV), influenza A virus (to type level only), influenza A H1 seasonal virus, influenza A H3 seasonal virus, influenza A virus H1-2009, influenza B virus, parainfluenza viruses 1 to 4, respiratory syncytial virus (RSV), and RV/EV (no differentiation). The larger panel in the FilmArray RP assay allowed the detection of additional respiratory pathogens compared to the Prodesse assays. In this population of young children with upper respiratory tract infection, RV/EV accounted for the majority of the additional pathogens detected by FilmArray RP.
我们比较了 FilmArray Respiratory Panel（RP）多重 PCR 检测试剂盒（Idaho Technology，Inc.，盐湖城，犹他州）的上市前版本与 Food and Drug Administration（FDA）批准的 Prodesse ProFlu+、ProFAST+、ProParaflu+、Pro hMPV+和 ProAdeno+实时 PCR 检测试剂盒（Gen-Probe，圣地亚哥，加利福尼亚州）的诊断性能和整体呼吸道病原体检测率。该检测方法在一个由 192 份鼻咽分泌物样本组成的小组中进行，这些样本来自 81 名年龄在 1 岁以下的上呼吸道症状儿童。为了解决不一致的结果并确认仅通过更大的 FilmArray 面板检测到的病原体，我们进行了实验室开发的实时 PCR 检测。在两种商业检测方法都可检测到的病毒（腺病毒、人类偏肺病毒、甲型流感病毒、乙型流感病毒、副流感病毒 1 至 3 型和呼吸道合胞病毒）中，FilmArray 和 Prodesse 检测方法总体上具有良好的一致性（181/192 [94.3%]；kappa=0.87；95%置信区间，0.79 至 0.94）。FilmArray RP 检测到的 1 型和 3 型副流感病毒比 ProParaflu+（18 比 13）多，而 ProAdeno+检测到的腺病毒更多（11 比 6），但这些差异没有统计学意义。此外，FilmArray RP 检测到了 138 种不在 Prodesse 检测试剂盒中的病原体（确认为真正的阳性）（鼻病毒/肠道病毒 [EV]，118 种；博卡病毒，8 种；冠状病毒，7 种；副流感病毒 4 型，4 种；肺炎支原体，1 种）。在这项研究完成后，FilmArray RP 获得了 FDA 的批准。FDA 批准的版本包括以下目标：腺病毒、冠状病毒 HKU1 和 NL63、人类偏肺病毒（hMPV）、甲型流感病毒（仅分型）、甲型流感 H1 季节性病毒、甲型流感 H3 季节性病毒、甲型流感 H1-2009、乙型流感病毒、副流感病毒 1 至 4 型、呼吸道合胞病毒（RSV）和鼻病毒/肠道病毒（无区别）。与 Prodesse 检测试剂盒相比，FilmArray RP 检测试剂盒的更大面板允许检测到更多的呼吸道病原体。在这个患有上呼吸道感染的幼儿人群中，鼻病毒/肠道病毒占 FilmArray RP 检测到的额外病原体的大多数。
