中国药物警戒 ›› 2014, Vol. 11 ›› Issue (10): 632-634.

• 药械安全性研究 • 上一篇    下一篇

弓形虫IgM抗体检测试剂临床研究要点

吕允凤   

  1. 国家食品药品监督管理局医疗器械技术审评中心,北京 100044
  • 收稿日期:2014-09-01 修回日期:2016-02-03 出版日期:2014-10-08 发布日期:2016-03-02
  • 作者简介:吕允凤,博士,助理研究员,体外诊断试剂及检测系统的上市前审查。

Clinical Trail of Diagnostic Reagents for IgM Antibody to Toxoplasma gondii

LV Yun-feng   

  1. Center for Medical Device Evaluation CFDA, Beijing 100044, China
  • Received:2014-09-01 Revised:2016-02-03 Online:2014-10-08 Published:2016-03-02

摘要: 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。

关键词: 弓形虫病, IgM抗体, 临床研究

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

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