Abstract:

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.

Key words: Mycobacterium tuberculosis, Antibodies, Reagent kits, diagnostic, Clinical trial, Problem-based learning