MODS法在结核分枝杆菌检测和药物敏感性实验中的临床应用评价

Evaluation of the microscopic observation drug susceptibility assay in clinical detection and drug susceptibility testing for mycobacterium tuberculosis

目的:评价MODS(显微观察药敏分析)技术在痰中结核分枝杆菌检测以及药物敏感性实验中的临床应用价值。方法:分别应用MODS法、L-J培养基培养和比例法(MOP)对涂阳肺结核患者痰标本中结核分枝杆菌进行检测和药敏实验,并对实验结果进行比较分析。结果:128份涂阳痰标本培养,MODS法与L-J培养的结核分枝杆菌阳性检出率分别为92.8%和84.13%(χ2=4.62,P<0.05);不同药物浓度(INH0.4μg/ml,INH0.1μg/ml;RIF1μg/ml,RIF0.5μg/ml)MODS法药敏实验结果与比例法(INH0.2μg/ml,RIF40μg/ml)的一致率分别为96.8%、95.2%、98.4%、96.8%,一致性程度Kappa值分别为0.91、0.87、0.94、0.90,两法在不同药物浓度下差异均无统计学意义(McNemar'sχ2分别为2、0.33、1和0,P值均大于0.1)。MODS法中分枝杆菌检测和药敏实验结果平均所需时间最短(9 d和9.5 d)。结论:MODS是一项符合发展中国家的廉价、快速、简便、高效的结核病培养诊断和药敏检测新技术。

Objective： To assess the application of the Microscopic Observation Drug Susceptibility Assay （MODS） in the detection and drug susceptibility test of M. tuberculosis in sputum specimens. Methods： Sputum samples from smear- positive TB Patients were analyzed and compared by using MODS, owenstein - Jensen medi- um,method of proportion to detect mycobacterial growth and observe drug susceptibility. Results： Of 128 smear- positive samples,the detection rates of M. tuberculosis by MODS and L -J were 92.8% and 84.13% respectively （χ2 = 4.62, P 〈 0.05 ）. The concordance rates of drug susceptibility test results obtained by MODS with concentra- tions of INH_0.4μg/ml, INH0.1 μg/ml; RIF1 μg/ml, RIF0.5μg/ml, and MOP with concentrations of INH0.2μg/ml, RIF40 μg/ml were 96.8% , 95.2% , 98.4% and 96.8% , the Kappa values were 0.91,0.87, 0.94 and 0.90. The difference of two methods had no statistical significance under different concentrations（ McNemar＇s χ2 =2, 0.33, 1, 0. All P 〉 0.1 ）. MODS cost the shortest time（ average 9 d and 9.5 d） in detection and drug susceptibility test of M. tubercu- losis. Conclusion： MODS is an inexpensive , rapid, convenient and sensitive method for MTB detection and suscep- tibility testing in developing countries.