Clinical trial of human immunodeficiency virus detection reagents
10.3760/cma.j.issn.1003-9279.2015.04.028
- VernacularTitle:人类免疫缺陷病毒检测试剂临床研究方法的建立
- Author:
Yunfeng LYU
1
;
Jinchun DONG
Author Information
1. 100044,北京国家食品药品监督管理总局医疗器械技术审评中心
- Keywords:
HIV;
Clinical trias
- From:
Chinese Journal of Experimental and Clinical Virology
2015;29(4):374-376
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish the main points of clinical trials of HIV detection reagents,including the study methods,clinical trial scheme setup,sample selection and statistical analysis of results.Methods Human Immunodeficiency Virus detection reagents including both quantitive and quanlitive detecting of HIV related biomarkers in human serum,plasma and other body fluid based on the immunological or molecular biological technique.Considering both the active regulations of IVD and the HIV detection reagent's own characteristics,the characteristics of clinical trials of the HIV detection reagents were described in detail.Results Significant problems have been settled in clinical trials of HIV detection reagents.Statistical analysis method should be used in the interpretation of clinical trial results.Conclusion Clinical trials of HIV detection reagents should be carried out scientifically and focus on the accuracy and specificity based on the clinical use.
