Abstract: According to the “active tuberculosis detection means” policy recommendations published by WHO，State Food and Drug Administration (SFDA) issued a notice named Guideline on further strengthening the supervision of tuberculosis serological diagnostic reagent. The notification required SFDA to conduct a background investigation of the domestic tuberculosis serological diagnostic products. The main purpose is to give some useful recommendations based on the evaluation of quality control in the production process of the domestic tuberculosis serological diagnostic reagents and to study the problems in the clinical evaluation. These recommendations will be served as the reference for the production，researches and clinical evaluation of tuberculosis serological diagnostic reagents.

Key words: Tuberculosis, Serological diagnostic reagent, Quality control, Clinical evaluation