CAJ | 학술논문

目的详细解析弓形虫IgM抗体检测试剂临床试验方法及注意事项。方法参照我国现行相关法规要求，在充分考虑本类试剂自身的特点的前提下，对其临床试验中应注意的法规问题和关键点进行了阐述。结果与结论弓形虫IgM抗体定性检测试剂在临床研究中应注意样本选择、试验方法等方面的特殊性，紧扣其临床预期用途进行充分的临床验证。
목적상세해석궁형충IgM항체검측시제림상시험방법급주의사항。방법삼조아국현행상관법규요구，재충분고필본류시제자신적특점적전제하，대기림상시험중응주의적법규문제화관건점진행료천술。결과여결론궁형충IgM항체정성검측시제재림상연구중응주의양본선택、시험방법등방면적특수성，긴구기림상예기용도진행충분적림상험증。
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 Sig nificant 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.