Discussion on clinical trial, production and quality control of in vitro Mycobacterium tuberculosis IFN-γ detection reagents

Abstract

Abstract: According to Management Method of In Vitro Diagnostic Reagents Registration (Interim) and other relevant laws and regulations, we summarize respectively the main raw materials, production process, product quality control and technical requirements of clinical study for in vitro Mycobacterium tuberculosis IFN-γ detection kits and provide technical support for the development and registration for such kits.

Key words: Mycobacterium tuberculosis, Interferon-gamma release tests, Reagent kits, diagnostic, Quality control

DU Wei-xin, CHEN Bao-wen, XU Miao, YANG Lei, LU Jin-biao, WANG Guo-zhi. Discussion on clinical trial, production and quality control of in vitro Mycobacterium tuberculosis IFN-γ detection reagents[J]. Chinese Journal of Antituberculosis, 2013, 35(9): 744-747.

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Discussion on clinical trial, production and quality control of in vitro Mycobacterium tuberculosis IFN-γ detection reagents

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