Evaluation of multiple test methods for the detection of the novel 2009 influenza A (H1N1) during the New York City outbreak.
Evaluation of multiple test methods for the detection of the novel 2009 influenza A (H1N1) during the New York City outbreak.
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DOI：
10.1016/j.jcv.2009.06.005
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发表时间：
2009-07
期刊：
影响因子：
--
通讯作者：
Crawford JM
中科院分区：
文献类型：
--
作者：
Ginocchio CC;Zhang F;Manji R;Arora S;Bornfreund M;Falk L;Lotlikar M;Kowerska M;Becker G;Korologos D;de Geronimo M;Crawford JM
为应对纽约市地区爆发的新型甲型H1N1流感，在5周内提交了6090例患者样本，共进行了14,114次病毒诊断测试，包括快速抗原、直接免疫荧光（DFA）、病毒培养和PCR。在季节性H1N1、H3N2和其他流行呼吸道病毒的背景下，这些检测方法检测新型H1N1的性能尚不清楚。此外，甲型流感亚型对于识别新型H1N1感染的高风险和/或住院患者以及监测疫情的传播至关重要。本研究分析了BinaxNOW流感A和B检测（BinaxNOW）、3M流感A + B快速检测（3MA + B）、直接免疫荧光、R-Mix培养和Luminex xTAG呼吸道病毒面板（RVP）检测季节性流感、新型H1N1等呼吸道病毒的性能。RVP还对其区分季节性H1N1、H3N2和新型H1N1的能力进行了评估。4种检测方法检测新型H1N1的敏感性、特异性、ppv和npv分别为：快速抗原检测：17.8%、93.6%、77.4%、47.9%；Dfa: 46.7%, 94.5%, 91.3%, 58.9%；R-Mix培养：88.9%,100%,100%,87.9%；Rvp: 97.8%, 100%, 100%, 97.3%与R-Mix培养相比，BinaxNOW和3MA + B检测新型H1N1的个体敏感性分别为9.6%和40%。所有经RVP鉴定并经CDC新型H1N1特异性RT-PCR检测的未分亚型甲型流感标本均证实为新型H1N1。快速抗原试验、DFA、R-Mix培养和xTAG RVP试验均检测到新型H1N1毒株，但灵敏度差异很大。RVP测试提供了最佳的诊断选择，因为RVP对所有流感毒株（包括新型H1N1）的检测都表现出卓越的敏感性，提供了准确的甲型流感亚型，并鉴定了大量额外的呼吸道病原体。
In response to the novel influenza A H1N1 outbreak in the NY City area, 6090 patient samples were submitted over a 5-week period for a total of 14,114 viral diagnostic tests, including rapid antigen, direct immunofluorescence (DFA), viral culture and PCR. Little was known about the performance of the assays for the detection of novel H1N1 in the background of seasonal H1N1, H3N2 and other circulating respiratory viruses. In addition, subtyping influenza A became critical for the identification of high risk and/or hospitalized patients with novel H1N1 infection and for monitoring the spread of the outbreak. This study analyzed the performances of the BinaxNOW Influenza A&B test (BinaxNOW), the 3M Rapid Detection Flu A + B test (3MA + B), direct immunofluorescence, R-Mix culture and the Luminex xTAG Respiratory Virus Panel (RVP) for the detection of seasonal influenza, novel H1N1 and other respiratory viruses. RVP was also evaluated for its ability to differentiate seasonal H1N1, H3N2 and novel H1N1. The sensitivities, specificities, PPVs and NPVs for the detection of novel H1N1, determined by comparing all four-test methods, were: rapid antigen: 17.8%, 93.6%, 77.4%, 47.9%; DFA: 46.7%, 94.5%, 91.3%, 58.9%; R-Mix culture: 88.9%, 100%, 100%, 87.9%; RVP: 97.8%, 100%, 100%, 97.3%. The individual sensitivities of BinaxNOW and 3MA + B as compared to R-Mix culture for the detection of novel H1N1 were 9.6% and 40%, respectively. All unsubtypeable influenza A specimens identified by RVP and tested with the CDC novel H1N1 specific RT-PCR assay were confirmed to be novel H1N1. Rapid antigen tests, DFA, R-Mix culture and the xTAG RVP test all detected the novel H1N1 strain, but with highly varied sensitivity. The RVP test provided the best diagnostic option as RVP demonstrated superior sensitivity for the detection of all influenza strains, including the novel H1N1, provided accurate influenza A subtyping and identified a significant number of additional respiratory pathogens.
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