Abstract: 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.  

Key words: Mycobacterium tuberculosis, Antibodies,bacterial, Indicators and reagents, Quality control