结核分枝杆菌复合群核酸检测试剂临床试验研究要点解析

Analysis of key points of clinical trail using nucleic acid reagent of Mycobacterium tuberculosis complex

【摘要】结核分枝杆菌复合群核酸检测试剂具有提高痰涂片阴性肺结核的检出率及肺结核诊断的特异度的优点，并可相对快速地鉴别结核分枝杆菌复合群与非结核分枝杆菌。结核分枝杆菌复合群核酸检测试剂在临床试验中应注意临床试验机构、对比试剂、样本等的选择，以及样本前处理方法和核酸提取方法的临床验证等问题。作者将主要对该类试剂在临床试验中的上述重点问题进行阐述。

Nucleic acid reagent of Mycobacterium tuberculosis complex could increase the detection rate of smear-negative pulmonary tuberculosis and the specificity of pulmonary tuberculosis diagnosis, and identify Mycobac- terium tuberculosis complex and non-tuberculous mycobacteria more rapidly. When this reagent used in clinical trials, the choose of clinical trial institution, sample and contrast reagents, etc. , and clinical verification of sample processing and nucleic acid extraction method should be concerned. The above key issues would be analyzed in this paper.