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目的 通过与直接荧光抗体染色法和流感病毒核酸检测方法——逆转录酶-聚合酶链反应(reverse transcriptase-polymerase chain reaction,RT-PCR)比较,探讨免疫荧光法流感病毒抗原检测试剂盒的临床应用价值.方法 采用流感病毒抗原检测(免疫荧光法)试剂盒(简称Sofia FIA)、直接荧光抗体染色法(DFA)和RT-PCR方法,对2017年7月至12月,350例发热门诊就诊患者进行病原学检测.结果 Sofia FIA方法共检出甲型亿型流感186例,总阳性检出率53.1%,其中检出甲型流感病毒35.4%,乙型流感病毒17.7%.Sofia FIA与RT-PCR比较,针对甲乙型流感联合检测,敏感性、特异性、阳性预测值、阴性预测值、一致率、kappa值分别为89.4%、100.0%、100.0%、86.6%、93.7%、0.873;针对甲型流感分别为87.9%、100.0%、100.0%、92.5%、95.1%、0.897;针对乙型流感分别为92.5%、100.0%、100.0%、98.3%、98.6%、0.952.DFA与RT-PCR比较,针对甲乙型流感联合检测,敏感性、特异性、阳性预测值、阴性预测值、一致率、kappa值分别为83.2%、100.0%、100.0%、80.2%、90.0%、0.800;针对甲型流感分别为82.3%、100.0%、100.0%、89.3%、92.9%、0.847;针对乙型流感分别为85.1%、100.0%、100.0%、96.6%、97.1%、0.902.结论 Sofia FIA与DFA方法的敏感性、特异性高,与RT-PCR的一致性高,用于流感的筛查有一定临床意义.“,”Objective To explore the clinical application value of fluorescent immunoassay kit for influenza virus antigen detection by comparing the method to the direct fluorescent antibody staining and the reverse transcriptase polymerase chain reaction (RT-PCR) of influenza virus nucleic acids.Methods From July to December 2017,350 patients in the fever clinic were examined by the fluorescent immunoassay kit for influenza virus antigen detection (Sofia FIA),direct fluorescent antibody staining (DFA)and RT-PCR of influenza virus nucleic acids.Results A total of 186 cases of influenza A/B viruses were detected by Sofia FIA,with an overall positive detection rate of 53.1%,and the detection rates of influenza A and B viruses were 35.4% and 17.7%,respectively.Compared to RT-PCR,the results of sensitivity,specificity,positive predictive value,negative predictive value,consistency rate and kappa value of Sofia FIA were 89.4%,100.0%,100.0%,86.6%,93.7% and 0.873 in the combined detection of influenza A/B viruses;87.9%,100.0%,100.0%,92.5%,95.1% and 0.897 in the detection of influenza A virus;and were 92.5%,100.0%,100.0%,98.3%,98.6% and 0.952 in the detection of influenza B virus,respectively.Compared to RT-PCR,the results of sensitivity,specificity,positive predictive value,negative predictive value,consistency rate and kappa value of DFA were 83.2%,100.0%,100.0%,80.2%,90.0% and 0.800 in the combined detection of influenza A/B viruses;82.3%,100.0%,100.0%,89.3%,92.9% and 0.847 in the detection of influenza A virus;and were 85.1%,100.0%,100.0%,96.6%,97.1% and 0.902 in the detection of influenza B virus,respectively.Conclusions Sofia FIA and DFA had high sensitivity and specificity,and were in consistency with RT-PCR.The methods showed have certain clinical significance in the screening of influenza.