线性探针检测技术对痰标本中耐药结核分枝杆菌快速检测的应用评价

目的 评价线性探针检测技术(LPAs)直接从痰标本中检测结核分枝杆菌复合群及其对耐多药结核病的快速检测。方法 连续收取193例临床涂片抗酸染色阳性的痰标本,直接用LPAs法从痰标本中进行结核分枝杆菌复合群及其对利福平和异烟肼耐药性的检测,结果与MGIT 960系统药物敏感性试验以及利福平、异烟肼耐药相关基因rpoB、katG、inhA和ahpC的基因测序结果进行比较,评价线性探针检测技术从痰标本中检测耐药结核分枝杆菌的灵敏度、特异度和符合率。统计学分析采用kappa检验。结果 LPAs法对涂阳痰标本结核分枝杆菌复合群检测的灵敏度为100.0%,耐利福平、耐异烟肼和耐多药结核分枝杆菌复合群检测的灵敏度分别为96.0%(48/50)、92.8%(64/69)和90.0%(45/50),特异度分别为99.3%(142/143)、100.0%(124/124)和99.3%(142/143),符合率分别为98.4%(190/193)、97.4%(188/193)和96.9%(187/193)。结论 LPAs法能够直接从涂阳痰标本中检测耐多药结核分枝杆菌,对耐利福平和耐异烟肼菌株具有较高的灵敏度和特异度,与MGIT 960系统药物敏感性试验结果的一致性较好,能够明显缩短从样本接收到得到药物敏感性试验结果的报告周期,为临床准确、快速地诊断耐多药结核病提供可靠的实验室依据,有利于耐药结核病的早期诊断。

Evaluation of the line probe assays for the detection of multidrug-resistant tuberculosis in smear-positive suptum specimens

Objective To evaluate the performance of the line probe assays(LPAs) for rapid detection of Mycobacterium tuberculosis complex and their resistance to rifampicin and isoniazid directly in smear-positive sputum specimens.Methods LPAs was used for detecting Mycobacterium tuberculosis complex and their resistance to rifampicin and isoniazid directly in 193 cases smear-positive sputum specimens,and the LPAs results were compared with the DST results obtained by MGIT 960 system and DNA sequencing analysis of rpoB,katG,inhA and oxyR-ahpC.We evaluated the sensitivity,specificity and agreement rates of LPAs for the detection of multidrug-resistant tuberculosis in smear-positive suptum specimens.The statistical analysis was performed by kappa test.Results The sensitivity of LPAs for detection of Mycobacterium tuberculosis complex in smear-positive sputum specimens was 100.0%.The sensitivity of LPAs for detection of rifampicin resistance,isoniazid resistance and MDR-TB in smear-positive sputum specimens were 96.0% (48/50),92.8% (64/69) and 90.0%(45/50),respectively.The specificity of LPAs for detection of rifampicin resistance,isoniazid resistance and MDR-TB in smear-positive sputum specimens were 99.3% (142/143),100.0% (124/124) and 99.3% (142/143), respectively.The agreement rates of rifampicin resistance,isoniazid resistance and MDR-TB were 98.4% (190/193), 97.4% (188/193) and 96.9% (187/193), respectively.Conclusion The LPAs is a rapid and reliable tool for the rapidly direct detection of Mycobacterium tuberculosis complex and their resistance to rifampicin and isoniazid in smear-positive sputum specimens. The rapid turnaround time of the test should enable the optimization of the therapy of these patients before confirmatory culture results are available.