rRNA扩增方法对结核分枝杆菌临床诊断作用的评估

目的 评价rRNA扩增方法 在临床应用的效果。 方法 选取到北京胸科医院、山东省胸科医院、河南疾控中心结核病防治所3个机构就诊的肺结核可疑症状者及健康志愿者的痰标本为研究对象，共纳入551例痰标本,对每例痰标本均进行涂片显微镜检查、罗氏培养、rRNA扩增试验以及实时荧光定量PCR。与罗氏培养方法 比较分析rRNA扩增方法 的敏感性、特异性、阳性预测值和阴性预测值以及与实时荧光定量PCR扩增方法 的一致性。 结果rRNA扩增方法 的敏感性为98.5%，特异性为95.0%，阳性预测值为95.0%，阴性预测值为98.5%，rRNA扩增方法 在涂阳标本和涂阴标本间的敏感度和特异度差异均有统计学意义（χ²=9.60，P=0.002；χ²=79.80，P<0.01）。与PCR检测结果的一致性为93.8%，涂阳和涂阴标本中2种方法 的一致性差异有统计学意义（χ²=4.45，P=0.035）。 结论 rRNA扩增方法 的敏感度和特异度均较好，且能明显缩短诊断时间，该方法 是一种较有前景的结核病实验室诊断方法 。

Evaluation of rRNA amplification assay for detection of Mycobacterium tuberculosis

Objective To evaluate the clinical value of rRNA amplification assay in the detection ofMycobacterium tuberculosis . Methods 551 sputum specimens from the patients with doubtful tuberculosis and health volunteers were detected using smear microscopy, L-J medium culture, rRNA amplification assay and real-time PCR. L-J culture used as control, the sensitivity, specificity, positive predictive value and negative predictive value of rRNA assay were analyzed. The accordance rate between rRNA assay and real-time PCR was also analyzed. Results Compared with L-J culture, the sensitivity, specificity, positive predictive value and negative predictive value of rRNA assay were 98.5%, 95.0%，95.0% and 98.5%, respectively. Its sensitivity and specificity had significant difference between smear-positive and smear-negative specimens (P<0.01). Accordance rate between rRNA amplification assay and real-time PCR was 93.8%, which had significant difference between smear-positive and smear-negative specimens (P<0.05). Conclusion rRNA amplification assay has a higher sensitivity and specitivity, can shorten the detection time. It would be a promising laboratory diagnosis method.