Ginocchio Christine C, Lotlikar Madhavi, Falk Leon, Arora Suman, Kowerska Margaret, Bornfreund Mark, Manji Ryhana
Department of Laboratory Medicine, North Shore-Long Island Jewish Health System Laboratories, Lake Success, NY 11042, USA.
J Clin Virol. 2009 Jun;45(2):146-9. doi: 10.1016/j.jcv.2009.03.018. Epub 2009 May 5.
The rapid diagnosis of influenza allows for prompt patient management and the initiation of appropriate infection control measures to reduce spread in healthcare settings.
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).
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.
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<or=0.0001) more sensitive than BinaxNOW for the detection of both influenza A and B. The analytical sensitivity of 3MA+B was greater than BinaxNOW. Excessive blood in samples may cause 3MA+B false positive influenza B results.
The 3MA+B provided superior results compared to BinaxNOW. The 3MA+B Reader eliminated user misinterpretation and provided quality control and result documentation. The improved sensitivity and easy of use makes 3MA+B an effective first line triage test for emergency departments, clinics and rapid response laboratories.
流感的快速诊断有助于及时对患者进行管理，并启动适当的感染控制措施，以减少医疗机构内的传播。
评估3M甲型/乙型流感快速检测试验（3MA+B）与R-Mix细胞培养、直接免疫荧光法（DFA）及BinaxNOW甲型/乙型流感检测试验（BinaxNOW）相比的临床性能。
对500份从5日龄至99岁有呼吸道症状的患者采集的新鲜呼吸道样本，采用R-Mix培养法、DFA、3MA+B和BinaxNOW进行检测。使用甲型或乙型流感阳性的系列稀释临床样本复制品，将3MA+B的分析灵敏度与BinaxNOW进行比较。
检测甲型和乙型流感的灵敏度、特异性、阳性预测值和阴性预测值，R-Mix分别为（96.9%，100%，100%，99.3%；98.1%，100%，100%，99.8%），DFA分别为（80.4%，99.2%，96.1%，95.3%；74%，100%，100%，97%），3MA+B分别为（70.1%，99.8%，98.6%，93%；86.5%，98.7%，88.2%，98.4%），BinaxNOW分别为（46.4%，100%，100%，88.6%；34.6%，100%，100%，93%）。在检测甲型和乙型流感方面，R-Mix、DFA和3MA+B比BinaxNOW显著更敏感（P≤0.0001）。3MA+B的分析灵敏度高于BinaxNOW。样本中血液过多可能导致3MA+B出现乙型流感假阳性结果。
与BinaxNOW相比，3MA+B的检测结果更优。3MA+B读数仪消除了用户的误判，并提供了质量控制和结果记录。灵敏度的提高和易用性使3MA+B成为急诊科、诊所和快速反应实验室有效的一线分诊检测方法。
Zotero 插件