GenoType MTBDRplus VER 2.0试剂盒检测痰标本中结核分枝杆菌复合群的效果评价  

Evaluation of GenoType? MTBDRplus VER 2.0 kit for detecting mycobacterium tuberculosis complex in sputum

作　　者：穆成[1] 江丽娜[1] 赵慧[1] 王志锐[1] 王春花[1] MU Cheng;JIANG Lina;ZHAO Hui;WANG Zhirui;WANG Chunhua(Tuberculosis Reference Laboratory,Tianjin Center for Tuberculosis Control,Tianjin 300041,China)

机构地区：[1]天津市结核病控制中心参比实验室,天津300041

出　　处：《公共卫生与预防医学》2020年第2期38-41,共4页Journal of Public Health and Preventive Medicine

摘　　要：目的评价GenoType? MTBDRplus VER 2.0试剂盒检测痰标本中结核分枝杆菌复合群(MTBC)的检测效能。方法对177例疑似肺结核患者的痰标本同时进行涂片,MGIT液体培养和GenoType? MTBDRplusVER 2.0检测。对培养阳性菌株进行菌种鉴定。使用SPSS 22.0统计软件对结果进行统计学分析,计数资料的一致性比较使用Kappa检验。K值≥0.75认为一致性很好。对MTBC检测的效能比较分析用敏感度、特异度进行效果评估。结果以MGIT液体培养结果为判断标准,GenoType? MTBDRplusVER 2.0检测痰标本中MTBC的敏感度为91.67%,特异度为95.58%,阳性预测值为91.67%,阴性预测值为95.58%,总符合率为94.22%。对两种方法进行一致性Kappa检验,K=0.872(P<0.001)。结论GenoType? MTBDRplus VER 2.0试剂盒检测痰标本中MTBC具有较高的敏感度和特异度,对于结核病的早期诊断有很好的应用价值。Objective To evaluate the performance of GenoType? MTBDRplus VER 2.0 kit for detecting Mycobacterium tuberculosis complex(MTBC)in sputum.Methods Sputum samples from 177 patients with suspected tuberculosis were collected,and tested by smear,MGIT liquid culture and GenoType? MTBDRplus VER 2.0.When the liquid culture was positive,identification of strains was carried out.The results were statistically analyzed using SPSS 22.0,and the consistency of the count data was compared using the Kappa test.Good consistency was defined as K≥0.75.The sensitivity and specificity were applied to evaluate the performance of GenoTypeMTBDRplus VER 2.0 kit for detecting MTBC in sputum.Results Based on the MGIT liquid culture results,the sensitivity,specificity,positive predictive value,negative predictive value and total coincidence rate of the GenoType? MTBDRplus VER 2.0 kit was 91.67%,95.58%,91.67%,95.58%and 94.22%,respectively.The Kappa test was performed on both methods,K=0.872(P<0.001).Conclusion GenoType? MTBDRplus VER 2.0 kit had high sensitivity and specificity for detecting MTBC in sputum,and it has good application value for early diagnosis of tuberculosis.

关 键 词：结核 分子探针技术 结核分枝杆菌 痰 

分 类 号：R183.3[医药卫生—流行病学]