Xpert MTB/RIF检测技术诊断结核病及其耐药的研究

摘要

Objective To discuss the diagnostic value and drug resistance situation of Xpert MTB/RIF analysis method in initially mycobacterium tuberculosis suspected Patients.Methods 430 examples of initially tuberculosis suspected patients were collected in Songjiang Central Hospital from Janurary to june in 2015.The sputum specimens were tested by acid-fast stain,MGIT 960 liquid culture and Xpert MTB/RIF method at the same time.The positive diffences and correspondences were analyzed among the three tests.Meanwhile,the 91 positive sputum specimens in liquid culture wer transmitted to the CDC in Shanghai to make bacteria identification and drug sensitivity tests.The sensitivity,specificity,accuracy and drug resistance situation of Xpert MTB/RIF test in tuberculosis patients were analyzed.Results The tuberculosis positive rates of 430 examples were respectively 14.19%,26.74%,22.79% through the three methods above.The correspondence rate between Xpert MTB/RIF and liquid culture was 89.53%(385/430).While The correspondence rate between Xpert MTB/RIF and acid-fast stain was 90.93%(391/430).There were 84 mycobacterium complex examples and 7 nonmycobacterium complex examples among the 91 positive sputum specimens in liquid culture.The sensitivity,specificity and accuracy of Xpert MTB/RIF test in tuberculosis patients were 77.38%(65/84),100.00%(7/7),79.12%(72/91).The results between Xpert MTB/RIF and proportional methods in 4 rifampicin resistance and 61 rifampicin sensitivity patients were fully consistent.Conclusion The positive rate is higher using Xpert MTB/RIF method than acid-fast stain assay,but in a good consistence with liquid culture method.In all,it is more sensitivity,specificity and accuracy of Xpert MTB/RIF test which can quickly and efficiently diagnose and find the drug resistance situation for tuberculosis patients.%目的 探讨多色巢式实时荧光定量核酸扩增(Xpert MTB/RIF)检测技术在初诊疑似肺结核患者中的诊断价值及其耐药性.方法 收集2015年1-6月在上海市松江区中心医院就诊的初诊疑似肺结核患者430例,对其痰标本同时进行痰涂片抗酸染色、MGIT 960液体分枝杆菌培养和Xpert MTB/RIF检测,比较3种方法诊断结核病的阳性率和符合度.同期将其中91例液体培阳的标本送至上海市疾病预防控制中心(CDC)进行分枝杆菌菌群鉴定(PNB法、TCH法和28 ℃培养试验)和一线抗结核药物(异烟肼、利福平、链霉素和乙胺丁醇)的敏感性试验(传统比例法),以上海市CDC鉴定结果为标准,分析Xpert MTB/RIF检测方法的敏感度、特异度和准确度及其耐药性.结果 430例患者中,痰涂片抗酸染色、液体培养和Xpert MTB/RIF 3种检测方法的分枝杆菌检出率分别为14.19%、26.74%、22.79%.Xpert MTB/RIF检测法与液体培养法的符合率为89.53%(385/430),与涂片法的符合率为90.93%(391/430).91例液体培养阳性患者,经上海市CDC菌群鉴定,84例为结核分枝杆菌复合群(MTC),7例为非结核分枝杆菌,Xpert MTB/RIF检测方法的敏感度为77.38%(65/84),特异度为100.00%(7/7),准确度为79.12%(72/91).Xpert MTB/RIF检测出的4例利福平耐药患者和61例利福平敏感患者与比例法药敏鉴定结果完全一致.结论 Xpert MTB/RIF检测方法阳性率明显高于涂片法,与传统液体培养法有较好的一致性.该方法具有较高的敏感度、特异度和准确度.