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目的:评价赛沛Xpert Xpress Flu/RSV Assay(后简称Xpert)在儿童流感病毒和呼吸道合胞病毒感染实验室检测的效果。方法:2018年10月—2019年2月，在北京儿童医院门诊采集急性呼吸道感染儿童的鼻咽拭子，所有样本均采用Xpert和测序方法进行检测，不一致结果样本使用第三方检测方法进行验证，比较Xpert和测序方法的灵敏度和特异性、阳性预测值和阴性预测值。结果:本研究共分析388份儿童急性呼吸道感染病例的鼻咽拭子样本的Xpert和测序法方法的检测结果。两种方法检测对FluA、FluB和RSV的结果具有较高的一致率，分别为：FluA 93.81% (364/388)、FluB 94.85% (368/388)和RSV 91.75% (356/388)。Xpert检测FluA、FluB和RSV相比测序方法具有较高的灵敏度，分别为99.21%(125/126)vs. 92.86%(117/126)、100.00%(109/109)vs. 84.40%(92/109)和100.00%(52/52)vs. 40.38%(21/52)。Xpert检测FluA、FluB和RSV的特异度均低于测序方法，95.42%(250/262)vs. 99.24%(260/262)、99.28%(277/279)vs. 99.64%(278/279)和99.70%(335/336)vs. 100.00%(336/336)。Xpert检测FluA、FluB和RSV的阳性预测值均低于测序方法，分别为91.30%(126/138)vs. 98.33%(118/120)、98.18%(108/110)vs. 98.92%(92/93)和98.11%(52/53)vs. 100.00%(21/21)。Xpert检测FluA、FluB和RSV的阴性预测值均高于测序方法，99.60%(251/252)vs. 96.67%(261/270)、99.64%(279/280)vs. 94.27%(280/297)和100.00%(337/337)vs. 91.60%(338/369)。结论:赛沛Xpert Xpress Flu/RSV Assay是一种快速、准确、可靠的可以适用于儿童检测流感病毒和RSV的分子诊断方法。“,”Objective:To evaluate the performance of the Cepheid Xpert Xpress Flu/RSV assay (Xpert) in the detection of children infected with influenza virus (Flu) or respiratory syncytial virus (RSV).Methods:Nasopharyngeal specimens were collected from children who showed symptoms of respiratory infection and tested FluA, FluB and RSV by Xpert and sequencing assay respectively side by side. Discordant result were tested with a laboratory-developed real-time PCR for resolution.Results:A total of 388 nasopharyngeal swabs (NAPs) from children with acute respiratory tract infection were analyzed and the result showed 91.75-94.85% agreement between two tests. The sensitivity of FluA, FluB and RSV detected by Xpert and sequencing assay were 99.21% (125/126) vs. 92.86% (117/126), 100.00% (109/109) vs. 84.40% (92/109) and 100.00% (52/52) vs. 40.38% (21/52), respectively. The specificity of FluA, FluB and RSV detected by Xpert were all lower than that of the sequencing assay: 95.42% (250/262) vs 99.24% (260/262), 99.28% (277/279) vs 99.64% (278/279) and 99.70% (335/336) vs 100.00% (336/336). The positive predictive values (PPV) of FluA, FluB and RSV detected by Xpert were lower than those of the sequencing assay: 91.30% (126/138) vs. 98.33% (118/120), 98.18% (108/110) vs. 98.92% (92/93) and 98.11% (52/53) vs. 100.00% (21/21), respectively. The negative predictive values (NPV) of FluA, FluB and RSV detected by Xpert were higher than those of the sequencing assay: 99.60% (251/252) vs. 96.67% (261/270), 99.64% (279/280) vs. 94.27% (280/297) and 100.00% (337/337) vs. 91.60% (338/369).Conclusions:The Cepheid Xpert Xpress Flu/RSV assay is a sensitive, reliable and rapid assay for the detection of FluA, FluB and RSV in pediatrics.