结核分枝杆菌抗体检测试剂生产质量控制与临床研究概述

The quality control of production of tuberculosis antibody detection reagents and the overview of its clinical research

依据国家食品药品监督管理局对体外诊断试剂研究与质量控制有关指导原则与《体外诊断试剂注册管理办法》(试行)的相关规定,参考《肺结核诊断标准》和《结核病诊断实验室检验规程》,探讨了结核分枝杆菌胶体金法和酶联免疫法抗体检测试剂的原辅材料、生产工艺、质量控制,以及临床评价研究的基本要求,为从事结核病血清学诊断试剂生产、研究单位及临床评价单位的同仁提供借鉴。

According to the guiding principle of the study and quality control on in vitro diagnostic reagents and ＂the registered management approach of in vitro diagnostic reagents＂（for trial implementation） from State Food and Drug Administration,＂the standard of diagnosis of pulmonary tuberculosis＂ and ＂the test procedures of tuberculosis diagnostic laboratory＂,this paper explores the raw and auxiliary materials,production process,quality control of tuberculosis antibody detection reagents by colloidal gold method and ELISA,and the basic requirements of its clinical evaluation to provide the reference for the production and research units of tuberculosis serological diagnostic reagents and their clinical evaluation units.