摘要
目的详细解析弓形虫Ig M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Ig M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。
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.
出处
《中国药物警戒》
2014年第10期632-634,共3页
Chinese Journal of Pharmacovigilance
