Clinical performance of the 3M Rapid Detection Flu A plus B Test compared to R-Mix culture, DFA and BinaxNOW Influenza A&B Test
Clinical performance of the 3M Rapid Detection Flu A plus B Test compared to R-Mix culture, DFA and BinaxNOW Influenza A&B Test
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DOI：
10.1016/j.jcv.2009.03.018
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发表时间：
2009-06-01
影响因子：
8.8
通讯作者：
Manji, Ryhana
中科院分区：
文献类型：
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作者：
Ginocchio, Christine C.;Lotlikar, Madhavi;Manji, Ryhana
背景资料：流感的快速诊断允许及时的患者管理和启动适当的感染控制措施，以减少在医疗机构中的传播。目的：评价3 M快速检测甲型流感+B检测试剂盒（3 MA +B）与R-Mix细胞培养、直接免疫荧光检测（DFA）和BinaxNOW甲型和B流感检测试剂盒的临床性能研究设计：通过R-Mix培养、DFA、3 MA +B和BinaxNOW测试从年龄为5天至99岁的具有呼吸道症状的患者收集的500个新鲜呼吸道样品。使用甲型或B型流感病毒阳性的系列稀释临床样本的重复样本，比较3 MA +B与BinaxNOW的分析灵敏度。结果：R-Mix检测甲型和B型流感病毒的灵敏度、特异性、PPV和NPV分别为（96.9%、100%、100%、99.3%; 98.1%、100%、100%、99.8%），DFA（80.4%。99.2%、96.1%、95.3%; 74%、100%、100%、97%）、3 MA +B（70.1%、99.8%、98.6%、93%; 86.5%、98.7%、88.2%、98.4%）和BinaxNOW（46.4%、100%、100%）。88.6%; 34.6%、100%、100%、93%）。R-Mix、DFA、3 MA +B组与对照组比较差异有显著性（P
Background: The rapid diagnosis of influenza allows for prompt patient management and the initiation of appropriate infection control measures to reduce spread in healthcare settings.Objective: To evaluate the clinical performance of the 3M Rapid Detection Flu A+B Test (3MA+B) as compared to R-Mix cell culture, direct immunofluorescence assay (DFA) and the BinaxNOW A&B Influenza Test (BinaxNOW).Study design: Five hundred fresh respiratory samples, collected from patients aged 5 days to 99 years with respiratory symptoms, were tested by R-Mix culture, DFA, 3MA+B and BinaxNOW. Analytical sensitivity of 3MA+B was compared to BinaxNOW using replicates of serially diluted clinical samples positive for influenza A or B.Results: Sensitivity, specificity, PPV and NPV for the detection of influenza A and B, respectively, were for R-Mix (96.9%, 100%, 100%, 99.3%; 98.1%, 100%, 100%, 99.8%), DFA (80.4%. 99.2%, 96.1%, 95.3%; 74%, 100%, 100%, 97%), 3MA+B (70.1%, 99.8%, 98.6%, 93%; 86.5%, 98.7%, 88.2%, 98.4%) and BinaxNOW (46.4%, 100%, 100%. 88.6%; 34.6%, 100%, 100%, 93%). R-Mix, DFA and 3MA+B were significantly (P