Xpert®Xpress Flu/RSV Assay用于临床呼吸道感染病原学诊断的价值  

The value of Xpert®Xpress Flu/RSV Assay in the diagnosis of respiratory pathogens of clinical specimens

作　　者：袁颖 谢争华 唐诗欢 陈满君 范笑地 余楠[1] YUAN Ying;XIE Zhenghua;TANG Shihuan;CHEN Manjun;FAN Xiaodi;YU Nan(Department of Laboratory Medicine,Zhujiang Hospital of Southern Medical University/Guangdong Key Laboratory of Pathogenic Microorganisms of Emergent Infectious Diseases,Guangzhou,Guangdong 510282,China;Department of Clinical Laboratory,Shenzhen Center,Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen,Guangdong 518116,China;Department of Clinical Laboratory,the Seventh Affiliated Hospital,Sun Yat-sen University,Shenzhen,Guangdong 518107,China)

机构地区：[1]南方医科大学珠江医院检验医学部/广东省突发传染病病原微生物重点实验室,广东广州510282 [2]中国医学科学院肿瘤医院深圳医院检验科,广东深圳518116 [3]中山大学附属第七医院检验科,广东深圳518107

出　　处：《国际检验医学杂志》2020年第16期1930-1934,共5页International Journal of Laboratory Medicine

基　　金：十三五国家重大科技专项(2017ZX10103011-006);广东省科技计划项目(2017A020215101)。

摘　　要：目的评估体外诊断试剂Xpert®Xpress Flu/RSV Assay(Xpress Flu/RSV)对临床甲型流感病毒(FluA)、乙型流感病毒(FluB)和呼吸道合胞病毒(RSV)标本的检测性能。方法选择2018年1月11日至5月9日于南方医科大学珠江医院就诊的420例具有呼吸道感染症状的患者为研究对象,采集鼻咽拭子标本,分别采用Xpress Flu/RSV和普通聚合酶链反应(PCR)测序进行检测,结果不一致标本采用自建反转录实时荧光定量聚合酶链反应(RT-qPCR)确认,以任意两种方法结果一致为标准,分析Xpress Flu/RSV的诊断性能。结果420例患者标本中Xpress Flu/RSV检出阳性213例(50.7%),灵敏度(FluA:100.0%;FluB:100.0%;RSV:100.0%)和特异度(FluA:100.0%;FluB:99.4%;RSV:99.7%)均较高;对其他呼吸道病原体(除FluA、FluB、RSV)感染标本检测结果均为阴性;95例患者标本Xpress Flu/RSV检测结果与自建RT-qPCR相比,一致性较高(Kappa值为0.949)。结论Xpress Flu/RSV检测性能较好,适用于病毒流行期的大规模筛查。Objective To evaluate the capability of in-vitro diagnostic reagent Xpert®Xpress Flu/RSV Assay(Xpress Flu/RSV)in the diagnosis of influenza A virus(FluA),influenza B virus(FluB)and respiratory syncytial virus(RSV)of clinical specimens.Methods A total of 420 nasopharyngeal swabs from patients with respiratory symptoms who were treated in Zhujiang Hospital of Southern Medical University were recruited into this study from January 11 to May 9,2018.They were tested by Xpress Flu/RSV and polymerase chain reaction(PCR)combined with sequencing,and discordant results were tested with a laboratory-developed reverse transcriptional real-time fluorescence quantitative PCR(RT-qPCR)for resolution to analyze the diagnostic performance of Xpress Flu/RSV.Results Among the 420 patients,213(50.7%)were positively detected.Xpress Flu/RSV performs well with sensitivity(FluA:100.0%;FluB:100.0%;RSV:100.0%)and specificity(FluA:100.0%;FluB:99.4%;RSV:99.7%).Patients infected with other pathogens(except FluA,FluB,RSV)were negative tested by Xpress Flu/RSV.A total of 95 cases among these patients were tested by Xpress Flu/RSV and laboratory-developed RT-qPCR,two methods performed well consistency(Kappa value was 0.949).Conclusion Xpress Flu/RSV performs well in diagnosing Flu/RSV,and which is worthy to be popularized in large-scale screening of viral epidemics.

关 键 词：呼吸道感染 Xpert®Xpress Flu/RSV Assay 测序 反转录实时荧光定量聚合酶链反应 

分 类 号：R446.5[医药卫生—诊断学]