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  • 宋红焕,李国莉,邵燕,等.不同分子生物学检测流程对肺结核病检出率及耐药患者发现率的影响[J].同济大学学报(医学版),2020,41(6):784-788.    [点击复制]
  • SONG Hong-huan,LI Guo-li,SHAO Yan,et al.Comparison of two molecular biological testing processes in detection of tuberculosis pathogen and drug-resistant tuberculosis patients[J].同济大学学报(医学版),2020,41(6):784-788.   [点击复制]
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不同分子生物学检测流程对肺结核病检出率及耐药患者发现率的影响
宋红焕,李国莉,邵燕,陈诚,竺丽梅,李燕
0
(江苏省疾病预防控制中心,南京210009)
摘要:
目的探讨江苏省各市分别采用两种不同耐药检测流程,全面开展分子生物学检测,对利福平耐药/耐多药患者发现率的影响。方法江苏省内各设区市、县分别采取两种不同的分子生物学检测流程进行结核分枝杆菌及耐药基因检测。流程1: 县级定点医疗机构采用恒温PCR方法(LAMP法)开展结核分枝杆菌分子生物学检测,市级定点医疗机构采用微阵列芯片法或线性探针技术耐药性检测;流程2: 县级定点医疗机构采用Xpert MTB方法开展结核分枝杆菌分子生物学检测,市级定点医疗机构采用线性探针技术耐药性检测。收集中国结核病管理信息系统中2015—2018年江苏省结核病登记数据,统计分析采用两种流程的地区,在结核病病原学阳性检测率、利福平耐药/耐多药患者发现能力等方面的差异。结果与传统实验室检测方法相比,采用分子生物学检测方法后,全省的病原学阳性检出率、利福平耐药/耐多药患者发现率有明显提高;采用两种流程的地区在利福平耐药/耐多药患者发现率上,差异没有统计学意义(P>0.05);流程2发现利福平耐药患者需约2.5h,低于流程1所需的约2周。结论采用分子生物学检测后,病原学阳性检出率、利福平耐药/耐多药患者发现率有明显提高,而两种不同分子生物学耐药检测流程在利福平耐药/耐多药患者发现率比较差异无统计学意义。
关键词:  肺结核  分子生物学检测  耐药患者发现率
DOI:10.16118/j.1008-0392.2020.06.017
投稿时间:2020-06-13
基金项目:国家科技重大专项(2017ZX10302301-004);江苏省防治艾滋病病毒性肝炎和结核病等重大传染病规模化现场流行病学和干预研究(298Z10715002);江苏省卫健委“六个一工程”拔尖人才项目(LGY2017083、LGY2018067);江苏省青年医学人才计划(QNRC2016541)
Comparison of two molecular biological testing processes in detection of tuberculosis pathogen and drug-resistant tuberculosis patients
SONG Hong-huan,LI Guo-li,SHAO Yan,CHEN Cheng,ZHU Li-mei,LI Yan
(Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China)
Abstract:
ObjectiveTo compare two molecular biology testing processes in detection of tuberculosis pathogens and rifampicin resistance/multidrug resistance(RR/MDR) tuberculosis patients. MethodsIn Jiangsu province, two molecular biological detection processes were adopted: 1. Thermostatic PCR was used to conduct molecular biological analysis in designated medical institutions at county level, while genechip or HAINS were used to detect drug-resistance in designated medical institutions at city level; 2. Xpert MTB was used for molecular biological analysis in designated medical institutions at county level, while HAINS was used to detect drug resistance in designated medical institutions at city level. The TB registration data of Jiangsu Province from 2015 to 2018 in China TB Management Information System were collected. The differences of RR/MDR rates in the two processes were compared. ResultsThe reported rates of positive detection and RR/MDR in the province increased significantly upon application of molecular biological detection methods; while the reported rates of RR/MDR patients in areas employing the above two processes were not significantly different. The detection of RR patients in process 2 took about 2.5h, which was significantly less than that in process 1(about 2 weeks). ConclusionThere is no significant difference in the detection rate of rifampicin-resistant/multidrug-resistant patients between 2 processes, but process 2 consumes less time in detection of rifampicin-resistant patients.
Key words:  pulmonary tuberculosis  molecular biology detection  discovery rate of drug resistant patients

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