在三级儿科环境中评估用于检测甲型和乙型流感病毒及呼吸道合胞病毒的荧光免疫分析快速检测法（Sofia™）。
Evaluation of a fluorescent immunoassay rapid test (Sofia™) for detection of influenza A+B and RSV in a tertiary pediatric setting.
作者信息
Piché-Renaud Pierre-Philippe, Turcot Jonathan, Chartrand Caroline, Gravel Jocelyn, Labrecque Manon, Vallières Émilie, Renaud Christian
机构信息
Département de pédiatrie, Centre Hospitalier Universitaire Ste-Justine, 3175 Chemin de la Côte-Sainte-Catherine, Montreal, H3T 1C4, QC, Canada.
Département de microbiologie et immunologie, Centre Hospitalier Universitaire Ste-Justine, 3175 Chemin de la Côte-Sainte-Catherine, Montreal, H3T 1C4, QC, Canada.
出版信息
Diagn Microbiol Infect Dis. 2016 Apr;84(4):304-8. doi: 10.1016/j.diagmicrobio.2015.10.025. Epub 2015 Oct 31.
In response to the lack of sensitivity and reproducibility of previously marketed rapid antigen detection tests, a novel fluorescent immunoassay was recently developed. This new assay offers rapidity and automated reading. More characterization of this assay is needed. The aim of this study was to assess diagnostic performance of Sofia influenza A+B and respiratory syncytial virus (RSV) while compared to traditional viral cell culture. A total of 416 respiratory samples were analyzed prospectively with both methods in a tertiary pediatric center. Sensitivity and specificity of the Sofia™ test were 90.0% and 98.0% for influenza A, 90.9% and 98.9% for influenza B, and 87.7% and 94.7% for RSV compared to traditional cell culture. Overall, Sofia influenza A+B and RSV assays performed well in comparison to culture in a pediatric population.
针对此前市售快速抗原检测试验缺乏敏感性和可重复性的问题，最近开发了一种新型荧光免疫测定法。这种新测定法具有快速性和自动读数功能。该测定法还需要更多的特性描述。本研究的目的是在与传统病毒细胞培养进行比较时，评估Sofia甲型和乙型流感病毒及呼吸道合胞病毒（RSV）检测的诊断性能。在一家三级儿科中心，采用这两种方法对总共416份呼吸道样本进行了前瞻性分析。与传统细胞培养相比，Sofia™检测对甲型流感的敏感性和特异性分别为90.0%和98.0%，对乙型流感分别为90.9%和98.9%，对RSV分别为87.7%和94.7%。总体而言，与儿科人群中的培养法相比，Sofia甲型和乙型流感病毒及RSV检测表现良好。
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