Evaluation of five rapid diagnostic kits for influenza A/B virus
Evaluation of five rapid diagnostic kits for influenza A/B virus
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DOI：
10.1016/j.jviromet.2012.09.003
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发表时间：
2013-01-01
影响因子：
3.1
通讯作者：
Kim, Woo Joo
中科院分区：
文献类型：
--
作者：
Cho, Chi Hyun;Woo, Mi Kyung;Kim, Woo Joo
流感病毒引起与高发病率和死亡率相关的季节性流行病。然而，即使在流行病流行期间，临床诊断也存在问题。用于检测大流行性流感A/B病毒的快速诊断测试因其易于使用而具有价值。最近在大韩民国（ROK）引入了许多快速流感诊断试剂盒，包括Directizen EZ Flu A和B（Becton Dickinson，Sparks，USA）、Binax Now Influenza A/B抗原试剂盒（Binax，波特兰，USA）、Genedia influenza Ag（绿色Cross，Yongin，ROK）、Humasis Influenza A/B抗原测试（Humasis，Anyang，ROK）和SD Bioline快速流感试剂盒（Standard Diagnostics，永仁，ROK）。本研究的目的是评价这五种快速诊断试剂盒的性能。并与病毒培养和逆转录-聚合酶链反应（RT-PCR）的结果进行比较。共分析了253例患者的253份鼻咽拭子（甲型流感，n = 67; B，n = 86;阴性样本，n = 100）。标本立即通过常规流感病毒培养和RT-PCR进行检测，储存在-80 ℃下，并使用5种快速检测试剂盒进行检测。5种快速检测试剂盒的性能各不相同，检测甲型流感和B流感的灵敏度分别为71.0%和82.1%，37.2%和47.7%。对于甲型流感，Directizen EZ Flu A和B、Binax Now Influenza A/B抗原试剂盒、Genedia influenza Ag、Humasis Influenza A/B抗原检测试剂盒和SD Bioline快速流感试剂盒的敏感性分别为82.1%、71.0%、76.1%、79.1%和82.1%; B型流感的阳性率分别为40.7%、37.2%、40.7%、41.8%和47.7%。所有快速检测的特异性均为100%。商业流感抗原检测测定是用于快速诊断流感的有用工具。但是，始终建议进行验证性测试。皇冠版权所有（C）2012由Elsevier B. V.出版。保留所有权利。
Influenza viruses cause seasonal epidemics associated with high morbidity and mortality. However, even during periods of epidemic prevalence, clinical diagnoses are problematic. Rapid diagnostic tests for the detection of pandemic influenza A/B virus are valuable for their ease of use. Many rapid influenza diagnostic kits were introduced recently in the Republic of Korea (ROK), including Directizen EZ Flu A and B (Becton Dickinson, Sparks, USA), Binax Now Influenza A/B antigen kit (Binax, Portland, USA), Genedia influenza Ag (Green Cross, Yongin, ROK), Humasis Influenza A/B antigen test (Humasis, Anyang, ROK), and SD Bioline rapid influenza kit (Standard Diagnostics, Yongin, ROK). The objective of this study was to evaluate the performance of these five rapid diagnostic kits. The results were compared with those of viral culture and reverse transcription (RT)-PCR. A total of 253 nasopharyngeal swabs were analyzed from 253 patients (influenza A, n = 67; B, n = 86; negative samples, n = 100). The specimens were tested immediately by conventional influenza virus culture and RT-PCR, stored at -80 degrees C, and tested using five rapid test kits. The performance of the five rapid tests kits varied with sensitivities between 71.0 and 82.1% and between 37.2 and 47.7% for detecting influenza A and B, respectively. For influenza A, the sensitivities of the Directizen EZ Flu A and B, Binax Now Influenza A/B antigen kit, Genedia influenza Ag, Humasis Influenza A/B antigen test, and SD Bioline rapid influenza kits were 82.1%, 71.0%, 76.1%, 79.1%, and 82.1%, respectively; those for influenza B were 40.7%, 37.2%, 40.7%, 41.8%, and 47.7%, respectively. The specificity of all rapid tests was 100%. Commercial influenza antigen detection assays are useful tools for the rapid diagnosis of influenza. However, confirmatory testing is always recommended. Crown Copyright (C) 2012 Published by Elsevier B.V. All rights reserved.