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结核分枝杆菌抗体检测试剂在结核病辅助诊断中的作用已写入相关指南.WHO对结核抗体检测试剂在临床的应用价值提出了质疑.作者分析了结核分枝杆菌抗体检测试剂在中国的注册现状并剖析了可能的原因;同时,对结核抗体检测试剂注册申报中的主要原材料、分析性能,以及临床试验中的重点问题进行了阐述.“,”The role of Mycobacterium tuberculosis antibody detection reagents in the diagnosis of tuberculosis has been involved in the related guidelines.The application of Mycobacterium tuberculosis antibody detection reagents in clinic has been questioned by the World Health Organization (WHO).This paper analyzes the current status of the registration of Mycobacterium tuberculosis antibody detection reagents in China and the possible reasons.Meanwhile,we expound the key issues of main raw materials,performance analysis and clinical trial in the registration and declaration of Mycobacterium tuberculosis antibody detection reagents.