MTBDR plus线性探针技术快速检测结核分枝杆菌耐药性的临床应用评价  

Evaluation of clinical application on the genotype MTBDR plus line probe assay for rapid detection of multidrugresistant Mycobacterium tuberculosis

作　　者：屈亚虹 李卫彬 马振亚 黄玉平 王瑜 马桦 张蕴淑 

机构地区：[1]开封市结核病防治所防治科,河南开封475004

出　　处：《中华疾病控制杂志》2013年第8期722-725,共4页Chinese Journal of Disease Control & Prevention

基　　金：中国卫生部-盖茨基金会结核病防治项目

摘　　要：目的评价线性探针杂交技术(简称HAIN技术)对耐药结核分枝杆菌的检测效果,评估其应用价值。方法利用传统罗氏培养及药敏试验和HAIN技术同时对开封市2010年4～10月份登记的453例涂阳肺结核患者进行耐多药检测,以传统罗氏培养及药敏试验为金标准对HAIN技术的检测效果进行评价。结果具有完整耐药检测结果的430例患者纳入分析。HAIN技术对新涂阳患者(P=0.589)和复治涂阳患者(P=1.000)耐药的检测效果与金标准差异无统计学意义。检测初治涂阳患者耐多药灵敏度为66.67%,Kappa值为0.56,阳性预测值为50.00%;检测复治涂阳患者耐多药的灵敏度为69.23%,Kappa值为0.61,阳性预测值为69.23%;所有检测结果的特异度均>91.00%,阴性预测值均>91.00%。结论 HAIN技术同传统方法检测涂阳肺结核患者耐药情况相比差异无统计学意义,但HAIN技术对初治涂阳患者耐多药的阳性预测值偏低,检测效果有一定局限性,可能会在实际应用中造成过度诊断。Objective To evaluate the effect of MTBDR plus linear probe assay （HAIN Lifescience, Nehren, Germany） on detecting the muhidrug-resistant （MDR） of Mycobacterium tuberculosis （TB） and assess the value of its ap- plication. Methods Both traditional Lwenstein-Jensen culture plus drug sensitivity test and the new MTBDR plus were used to diagnose MDR-TB of 453 sputum smear-positive （ SS ＋ ） pulmonary TB cases registered in Kaifeng Prefecture from April to October, 2010. The traditional method was used to evaluate the detection effects of the new method as golden standard. Results Four hundred and forty three patients with complete MDR detection results were enrolled in the analy- sis. There was no significant difference between MTBDR plus and gold standard in terms of test result with new SS ＋ cases （P = 0. 589） and retreatment cases （ P = 1. 000）. The sensitivity of new SS ＋ MDRTB diagnosis was 66. 67% with the Kappa value of 0. 56 and positive predictive value of 50%. The sensitivity of retreated SS ＋ MDRTB diagnosis was 69.23% with the Kappa value of 0. 61 and positive predictive value of 69. 23 %. The specificity and negative predictive val- ue of all detection results were 〉 91.00%. Conclusions There is no significant difference between MTBDR plus linear probe assay and the traditional method for INH and RFP resistance detection. But there is limitation that the positive pre- dictive value of the MTBDR plus techniques to diagnose new SS ＋ cases is rather low, which may cause over-diagnosis.

关 键 词：分枝杆菌 结核 基因型 评价研究 

分 类 号：R52[医药卫生—内科学]