PCR-ELISA测定结核分枝杆菌DNA临床应用评价

Clinical Evaluation of polymerase chain reaction-enzyme linked immunosorbent assay for the detection of mycobacterium tuberculosis DNA

目的 评价聚合酶链反应 酶联免疫吸附试验 (PCR ELISA)测定结核分枝杆菌DNA临床应用价值。方法 用PCR ELISA测定 436例肺结核、172例非结核病人痰标本中的结核分枝杆菌DNA ,并结合临床诊断和痰菌检查对实验结果进行分析。结果 436例活动性肺结核病人本法最终阳性 341例 ,阳性率 78.2 1% ,其中痰菌阳性病人本法阳性率为 97.0 7% ,痰菌阴性病人阳性率为 5 5 .33 % (10 9/ 197) ;而 172例对照患者只有 3例假阳性 ,假阳性率 1.74%。结论 本法测定痰液结核分枝杆菌DNA对肺结核的诊断具有很高的敏感性和特异性 。

Objective To evaluate the clinical use of polymerase chain reaction enzyme linked immunosorbent Assay for the detection of Mycobacterium tuberculosis DNA. Methods 436 patients with pulmonary tuberculosis and 172 non tuberculosis patients were tested for Mycobacterium tuberculosis DNA in sputum samples, and the results were compared with the clinical diagnosis and the bacterial examination.Results The positive rate of the assay was 78.21% for active pulmonary tuberculosis, in this group the positive rate was 97.07% and 55.33% for sputum bacterial test positive and negative patients respectively. There was 1.74% false positive rate in non tuberculosis patients.Conclusion This assay posseses high specificity and sensitivity for the diagnosis of pulmonary tuberculosis, especially for sputum bacterial test negative patient.