Abstract: Objective To discuss the main points of clinical trails of diagnostic reagents for IgM antibody to Toxoplasma gondii. Methods Considering both the active regulations of IVD and the reagent's own characteristics, the feature of clinical trails of diagnostic reagents for IgM antibody to Toxoplasma gondii were analysised. Results Significant problems have been settled such as classification, study method, clinical trail scheme setup, sample selection, statistical analysis of results and reports composing. Conclusion Clinical trails of diagnostic reagents for IgM antibody to Toxoplasma gondii reagents should be carried out scientifically and focus on the accuracy and specificity, based on the active regulations and it's own clinical use.

Key words: toxoplasmosis, IgM antibody, clinical trail