【摘要】 目的评价GenoType MTBDRplus快速检测耐多药结核分枝杆菌复合群(multi-drug resistant Mycobacterium tuberculosis Complex,MDR-MTBC)临床分离株的应用效能。方法随机抽取福建省30个耐药监测点的129株MTBC包括全敏感菌株50株和79株MDR菌株,应用MTBDRplus检测,同时扩增MDR菌株的rpoB,katG,inhA基因进行测序比对,并将检测结果与比例法药敏结果比较分析。结果 129株MTBC经MTBDRplus检测,Tub条带均阳性(100%),50株全敏感株的检测结果与比例法药敏结果完全一致。79株MDR菌株经MTBDRplus检出67株(84.81%)MDR,10株(12.66%)单耐RFP,2株(2.53%)单耐INH。经测序,77株MDR菌株的rpoB基因检测出突变,71株的katG和/或inhA检测出突变。以比例法药敏结果为金标准,MTBDRplus检测RFP、INH耐药性及MDR的敏感度分别为97.47%(77/79),87.34%(69/79),84.81%(67/79),MTBDRplus检测RFP、INH耐药性及MDR的特异度均为100%(50/50),一致率分别为98.45%(127/129),92.25%(119/129),90.70%(117/129)。结论 MTBDRplus是一种快速、准确、操作简便的技术,具有很好的应用前景,适用于耐多药结核分枝杆菌临床分离株的快速检测,但灵敏度有待进一步提高。更多还原

【Abstract】 We conducted evaluation on the performance of GenoType MTBDRplus assay for rapid detecting multi-drug resistant Mycobacterium tuberculosis Complex(MDR-MTBC)isolates in Fujian Province,China.The strains including 79 MDR and 50pan-susceptible were chosen randomly from 30 survey sites.The MTBDRplus was applied to detect RFP and INH resistance of the strains,and the results were compared with the result of sequencing data about rpoB,katGand inhA mutation.The Tub control were positive in all strains(100%),the results showed the patterns of 50pan-susceptible strains were concordant with DST.By the assay,67(84.81%)MDR strains of 79 were correctly identified,10strains(12.66%)were mono resistant to RFP,and 2were mono resistant to INH.The mutation in rpoBgene of 77 MDR strains and in katG/inhAgene of 71 MDR strains was detected by sequencing.Provided that conventional DST is the "gold standard," the sensitivity of the MTBDR assay were 97.47%for RFP resistance detection,87.34%for INH resistance detection and 84.81%for MDR detection.And the assay had the specificity of 100%for the detection of RFP,INH and MDR.The concordance rate of detection for RFP,INH and MDR was 98.45%(127/129),92.25%(119/129),90.70%(117/129),respectively.Thus,the new GenoType MTBDRplus assay represents a rapid,reliable and easy tool for the detection of INH and RFP resistance in clinical strains of MDR in Fujian Province and the sensitivity needs to be improved.更多还原