Evaluation of Wondfo influenza A&B fast test based on immunochromatography assay for rapid diagnosis of influenza A H1N1.
Evaluation of Wondfo influenza A&B fast test based on immunochromatography assay for rapid diagnosis of influenza A H1N1.
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DOI：
10.1016/j.bjid.2012.09.014
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发表时间：
2013-03
影响因子：
3.4
通讯作者：
Li, Wenmei
中科院分区：
文献类型：
--
作者：
Peng, Yunping;Wu, Junlin;Liu, Xiaoyun;Wang, Jihua;Li, Wenmei
在局部暴发或流行期间，流感病毒会导致儿童和成人显着发病和死亡。因此，对甲型和乙型流感进行快速检测是有用的。本研究旨在评估万孚 A&B 流感检测快速诊断甲型 H1N1 流感感染的临床表现。快速检测可以区分甲型和乙型流感病毒的感染。参考病毒株在 MDCK 细胞中培养，如果确定病毒则为 TCID50。 Wondfo 试剂盒的分析灵敏度为 100 TCID50/ml。 Wondfo 试剂盒未表现出与其他常见病毒的交叉反应性。通过万孚甲乙型流感检测和其他市售产品对 1928 例甲型 H1N1 流感病毒感染疑似病例进行了分析。通过细胞培养中的病毒分离进一步证实了不一致的结果。甲型流感的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）分别为100%、98.23%、92.45%和100%，乙型流感的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）分别为96.39%、99.95%、98.77%和99.84%。万孚甲型、乙型流感检测和RT-PCR对766例疑似甲型H1N1流感病毒感染病例进行了分析。甲型流感的敏感性、特异性、PPV 和 NPV 分别为 56.5%、99.75%、99.52% 和 71.04%，乙型流感为 25.45%、99.86%、93.33% 和 94.54%。这些结果表明，万孚甲乙型流感检测具有较高的阳性检出率和阴性检出率。经RT-PCR确诊的156份甲型H1N1流感标本，经万孚甲乙型流感检测试剂盒检测呈阳性，阳性率为66.67%，而参考试剂盒的阳性率仅为18.59%。这些结果表明我们的快速诊断检测可能有助于分析患者标本中的甲型 H1N1 流感感染。
Influenza viruses cause significant morbidity and mortality in both children and adults during local outbreaks or epidemics. Therefore, a rapid test for influenza A&B would be useful. This study was conducted to evaluate the clinical performance of the Wondfo influenza A&B test for rapid diagnosis of influenza A H1N1 Infection. The rapid testing assay could distinguish infection of influenza A and B virus. The reference viral strains were cultured in MDCK cells while TCID50 if the viruses were determined. The analytical sensitivity of the Wondfo kit was 100 TCID50/ml. The Wondfo kit did not show cross reactivity with other common viruses. 1928 suspected cases of influenza A (H1N1) virus infection were analyzed in the Wondfo influenza A&B test and other commercially available products. Inconsistent results were further confirmed by virus isolation in cell culture. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were 100%, 98.23%, 92.45%, and 100% for flu A, and 96.39%, 99.95%, 98.77%, and 99.84% for flu B respectively. 766 suspected cases of influenza A (H1N1) virus infection were analyzed in the Wondfo influenza A&B test and RT-PCR. The sensitivity, specificity, PPV and NPV were 56.5%, 99.75%, 99.52% and 71.04% for flu A, 25.45%, 99.86%, 93.33% and 94.54% for flu B respectively. These results indicate that the Wondfo influenza A&B test has high positive and negative detection rates. One hundred fifty-six specimens of influenza A (H1N1) confirmed by RT-PCR were analyzed by the Wondfo influenza A&B test and 66.67% were positive while only 18.59% were positive by the reference kit. These results indicate that our rapid diagnostic assay may be useful for analyzing influenza A H1N1 infections in patient specimen.
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