Tuttle Ryan, Weick Anja, Schwarz Wiebke Sabrina, Chen Xi, Obermeier Patrick, Seeber Lea, Tief Franziska, Muehlhans Susann, Karsch Katharina, Peiser Christian, Duwe Susanne, Schweiger Brunhilde, Rath Barbara
Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany.
Division for Influenza and Other Respiratory Viruses, National Reference Centre for Influenza, Robert-Koch Institute, Nordufer 20, Berlin 13353, Germany.
Diagn Microbiol Infect Dis. 2015 Mar;81(3):171-6. doi: 10.1016/j.diagmicrobio.2014.11.013. Epub 2014 Dec 3.
Acute respiratory infections represent common pediatric emergencies. Infection control warrants immediate and accurate diagnoses. In the past, first-generation respiratory syncytial virus (RSV) rapid tests (strip tests) have shown suboptimal sensitivities. In 2013, the Food and Drug Administration licensed a second-generation RSV rapid test providing user-independent readouts (SOFIA™-RSV) using automated fluorescence assay technology known to yield superior results with influenza rapid testing. We are reporting the first point-of-care evaluation of the SOFIA™-RSV rapid test. In the Charité Influenza-Like Disease Cohort, 686 nasopharyngeal samples were tested in parallel with SOFIA™-RSV and SOFIA™-Influenza A+B. Compared to real-time PCR, SOFIA™-RSV sensitivities/specificities were 78.6%/93.9%, respectively (SOFIA™-Influenza A: 80.6%/99.3%). Performance was greatest in patients below 2 years of age with a test sensitivity of 81.8%. RSV sensitivities were highest (85%) in the first 2 days of illness and with nasopharyngeal compared to nasal swabs (P=0.055, McNemar's test). Second-generation RSV and influenza rapid testing provides highly accurate results facilitating timely patient cohortation and management.
急性呼吸道感染是常见的儿科急症。感染控制需要即时且准确的诊断。过去，第一代呼吸道合胞病毒（RSV）快速检测（试纸检测）的灵敏度欠佳。2013年，美国食品药品监督管理局批准了一种第二代RSV快速检测方法（SOFIA™-RSV），该方法采用自动荧光检测技术，可提供独立于用户的读数，这种技术在流感快速检测中已显示出卓越的效果。我们正在报告对SOFIA™-RSV快速检测的首次即时检测评估。在夏里特流感样疾病队列中，对686份鼻咽样本同时进行了SOFIA™-RSV和SOFIA™-甲型/乙型流感检测。与实时聚合酶链反应相比，SOFIA™-RSV的灵敏度/特异性分别为78.6%/93.9%（SOFIA™-甲型流感：80.6%/99.3%）。在2岁以下的患者中检测性能最佳，检测灵敏度为81.8%。在发病的前两天，RSV的灵敏度最高（85%），且鼻咽拭子检测的灵敏度高于鼻拭子（P=0.055，McNemar检验）。第二代RSV和流感快速检测提供了高度准确的结果，有助于及时对患者进行分组和管理。
