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目的:通过大样本流感样病例检测，明确抗原检测与核酸检测两种方法联合应用原则，从而快速明确流感诊断，控制流感暴发，减少资源浪费。方法:采集2019年1月至2020年1月北京同仁医院发热门诊的4 622份流感样病例咽拭子标本，其中流感季3 230份，非流感季1 392份，采用快速抗原法和实时荧光逆转录聚合酶链反应（qPCR）两种方法对其进行流感病毒检测。不一致结果采用第二种核酸检测试剂进行比对。比较快速抗原法对于不同年龄敏感度与特异度的差异，以及不同亚型、不同病毒载量的检出差异。结果:甲型流感病毒快速抗原法的敏感度为33.7%（577/1 710），特异度为93.5%（2 723/2 912），与qPCR的一致率为71.4%（3 300/4 622）。在流感季，甲型流感病毒快速抗原法阳性预测值及阴性预测值分别为84.1%（570/678）和57.4%（1 464/2 552）。在非流感季，其阳性预测值及阴性预测分别为8.0%（7/88）和96.5%（1 259/1 304）。甲型流感病毒快速抗原法与乙型流感病毒存在交叉反应，为2.3% （18/766）。儿童的敏感度比成人高［56.7%（164/289）比29.1%（413/1 421）］。快速抗原法对于不同流感亚型（H1N1和H3N2）的检出率差异无统计学意义（χn 2=0.131，n P=0.718），其敏感度随循环阈值（Ct值）增大而降低。n 结论:甲型流感病毒快速抗原法阳性结果可确诊。在流感季，甲型流感病毒抗原阴性应进行核酸检测，而非流感季阴性结果可排除感染。快速抗原法对儿童的敏感度比成人高，敏感度与Ct值呈负相关。“,”Objective:By detecting a large number of influenza-like cases, the principles of the combined application of rapid influenza diagnostic test (RIDT) and real-time quantitative polymerase chain reaction (qPCR) is clarified, so as to quickly confirm the diagnosis of influenza, control the outbreak of influenza and reduce waste of resources.Methods:Throat swabs of 4 622 influenza-like cases were prospectively collected from the fever clinic of Beijing Tongren Hospital from January 2019 to January 2020, of which 3 230 were in influenza season and 1 392 were in non-influenza season. Influenza virus in these samples was detected by rapid antigen method and qPCR. The inconsistent results were compared with the second nucleic acid detection reagent. The sensitivity and specificity of the rapid antigen method to people of different ages, as well as the detection differences of different subtypes and different viral loads were compared.Results:For RIDT, the sensitivity was 33.7% (577/1 710), the specificity was 93.5% (2 723/2 912), and its consistency rate with qPCR was 71.4% (3 300/4 622). For the samples collected in the influenza season, the positive predictive value and negative predictive value of RIDT for influenza A virus were 84.1% (570/678) and 57.4% (1 464/2 552), respectively. For those collected during the non-influenza season, the positive predictive value and negative predictive value were 8.0% (7/88) and 96.5% (1 259/1 304), respectively. There was a cross-reaction between influenza A virus and influenza B virus in RIDT with a value of 2.3% (18/766). The sensitivity of children was higher than that of adults, which were 56.7%(164/289) and 29.1%(413/1 421), respectively. There was no significant difference in the detection rate of different influenza subtypes (H1N1 and H3N2) by RIDT (χn 2=0.131, n P=0.718). The sensitivity of RIDT decreased with the increase of the circulation threshold(Ct).n Conclusions:Positive results from RIDT can be used to confirm the diagnosis. During the influenza season, nucleic acid tests should be considered to confirm the negative test results of RIDT, and the negative results of RIDT can rule out infections in the non-influenza seasons. The sensitivity of RIDT to children was higher than that to adults, and it was negatively correlated with Ct value.