Performance of rapid SOFIA Influenza A plus B test compared to Luminex x-TAG respiratory viral panel assay in the diagnosis of influenza A, B, and subtype H3
Performance of rapid SOFIA Influenza A plus B test compared to Luminex x-TAG respiratory viral panel assay in the diagnosis of influenza A, B, and subtype H3
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DOI：
10.1136/jim-2016-000055
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发表时间：
2016-04-01
影响因子：
2.6
通讯作者：
Rao, L. V.
中科院分区：
文献类型：
--
作者：
Selove, W.;Rao, L. V.
流感是由甲型或乙型流感病毒引起的急性呼吸道疾病，主要在冬季爆发。流感的快速实验室诊断有助于有效指导疑似患者的临床管理。文献中快速流感诊断测试的临床敏感性和特异性差异很大。大多数这些研究都是使用先前冷冻或储存的先前检测呈阳性的标本进行评估的。本研究比较了快速 SOFIA 流感 A+B 检测与核酸多重检测 x-TAG 呼吸道病毒检测 (RVP) 检测在新鲜收集的鼻吸出物中的性能，并通过两种检测同时进行测量。对从成人和儿童收集的 1649 份鼻吸液（2014 年 9 月至 2015 年 5 月）的回顾性数据进行了分析，这些数据通过快速 SOFIA 流感 A+B FIA 免疫荧光（Quidel，圣地亚哥，加利福尼亚州）和定性核酸多重 RVP 测定 X-TAG Luminex 技术（Luminex，奥斯汀，德克萨斯州，美国）同时进行测试。对甲型流感、H1 和 H3 亚型以及乙型流感的一致性、分析灵敏度和特异性进行了评估。按 RVP 计算，甲型流感的患病率为 15%，H3 亚型为 11.2%，乙型流感为 2.9%。抽吸物均未呈甲型流感 H1 亚型阳性。与甲型流感、H3 亚型和乙型流感核酸检测相比，SOFIA 流感快速检测表现出良好的特异性和较低的敏感性。SOFIA A + B 流感检测在提供快速诊断方面表现良好，但建议对阴性检测结果进行确认性分子检测。在疫情爆发期间，随着新流感毒株的出现和传播，应定期对检测性能进行重新评估。
Influenza is an acute respiratory illness caused by influenza A or B viruses that occur in outbreaks, mainly during the winter season. Rapid laboratory diagnosis of influenza can help guide the clinical management of suspected patients effectively. Clinical sensitivities and specificities of the rapid influenza diagnostic tests have varied considerably in the literature. Most of these studies are evaluated using previously frozen or stored specimens that had previously tested positive. This study compares the performance of the rapid SOFIA Influenza A+B test to nucleic acid multiplex test x-TAG respiratory viral panel (RVP) assay in freshly collected nasal aspirates and measured simultaneously by both assays. Retrospective data from 1649 nasal aspirates (September 2014 to May 2015) collected from adults as well as from children tested simultaneously by both rapid SOFIA Influenza A+B FIA immunofluorescence (Quidel, San Diego, CA) and qualitative nucleic acid multiplex RVP assay X-TAG Luminex technology (Luminex, Austin, Texas, USA) were analyzed. Concordance, and analytical sensitivity and specificity were evaluated for influenza A, subtypes H1 and H3, and influenza B. Prevalence for influenza A by RVP was 15%, for subtype H3 it was 11.2%, and for influenza B, 2.9%. None of the aspirates were positive for influenza A subtype H1. SOFIA Influenza rapid test demonstrated good specificity and low sensitivity compared with a nucleic acid test for influenza A, subtype H3, and for influenza B. SOFIA Influenza A + B test performed well in providing a rapid diagnosis, however, confirmatory molecular testing is recommended for negative test results. Re-evaluation of test performance should be periodically carried out during outbreaks with the emergence and circulation of new influenza strains.