MTBDRplus技术快速检测结核分枝杆菌耐多药的临床应用评价

Clinical evaluation of MTBDRplus linear probe assay for rapid detection of multidrug-resistant Mycobacterium tuberculosis

目的评价线性探针杂交技术(简称MTBDRplus技术)对福州地区耐药结核杆菌的检测效果,并了解该地区耐药结核分枝杆菌的耐药基因特征。方法选取246株临床结核分枝杆菌分离株,以传统罗氏药敏试验为金标准,评价MTBDRplus技术在临床上应用的检测效果,分析耐药基因突变分布频率。结果与传统罗氏药敏试验相比较,MTBDRplus检测利福平(RIF)和异烟肼(INH)耐药性灵敏度分别为91.7%(11/12)和83.3%(15/18),MTBDRplus检测RIF和INH耐药性特异度分别为99.6%(233/234)和95.2%(217/228)。12例rpoB基因存在突变的结核分枝杆菌中,58.3%rpoB基因S531L突变;26例katG和inhA基因存在突变的结核分枝杆菌中,57.7%(15/26)katG基因315突变;存在C15T位点突变的菌株仅9.1%(1/11)为INH耐药菌株。结论 MTBDRplus技术是一个敏感、特异的快速诊断耐多药结核病的有效方法,该技术在福州地区具有较好的应用前景。福州市耐药结核分枝杆菌以rpoB S531L和katG S315T突变型为主。建议谨慎判断结核分枝杆菌inhA基因C15T位点突变引起的INH耐药。

To evaluate the efficiency of MTBDRplus linear probe assay(MTBDRplus)for detecting multidrug resistant(MDR)Mycobacterium tuberculosis(TB)in Fuzhou.A total of 246 clinical TB isolates were included in the study.Traditional Lwenstein-Jensen culture plus drug sensitivity test was used as the gold standard to evaluate the results of the new MTBDRplus.The variety of gene mutations were also assessed.The sensitivity of MTBDRplus for detection of resistance to Rifampicin(RIF)and Isoniazide(INH)were 91.7%(11/12)and 83.3%(15/18).The specificity of MTBDRplus for detection of RIF and INH were 99.6%(233/234)and 95.2%(217/228).Among them,58.3%were S531L mutation in 12 TB cases with rpoB gene mutation.Of the 26 cases of TB with gene mutations of katG and inhA,57.7%(15/26)was S315T mutation of katG gene.Only 9.1%(1/11)of isolates with C15T mutation were the INH resistant strains.MTBDRplus technology is a sensitive and specific method for rapid diagnosis of MDR-resistant tuberculosis.The technology has a good prospect in Fuzhou area.The resistant strains of TB in Fuzhou were mainly rpoB S531L and katG S315T mutations.It is recommended to carefully determine the INH resistance of M.tuberculosis caused by inhA gene C15T mutation.