人类免疫缺陷病毒检测试剂临床研究方法的建立.pdfVIP

.374. 中华实验和临床病毒学杂志 2015 年 8 月第 29 卷第4 期 Chinese J Exp Clin Virol , August 2015 ,Vol. 29 ， Nι4 ·技术指南· 人类免疫缺陷病毒检测试剂临床 研究方法的建立 吕允凤，董劲春 [摘要1 目的 建立人类免疫缺陷病毒检测试剂临床研究方法，解析方案设计、临床试验样本 选择、结果的统计学分析等方面的具体要求。方法 人类免疫缺陷病毒检测试剂是指利用免疫学及 分子生物学等方法对人血清、血浆或其他体液中的特定的人类免疫缺陷病毒生物学标记物进行定量 或定性分析的试剂。结合体外诊断试剂现行法规及此类试剂自身的特点，对临床研究的具体内容进 行详细解析。结果 该研究详细解析了该类试剂的临床研究方法细节要求。对于临床试验的检测 结果应用统计学方法进行分析。结论 不同的人类免疫缺陷病毒检测试剂的临床性能评价应从试 剂本身的临床预期用途出发，重点针对试剂定性、定量的准确性、特异性进行科学的临床考察。 [主题词) HIV; 临床试验 Clinical trlal of human immunodeficiency virus detection reagents Lyu Yu呐晤， Dong Jinchun. Center for Medical Device Evaluation CFDA Beijing 100044 , China Corresponding author: Dong Jinchun , Email: dongjch@cmde.org.cn Abstract) 0时ec伽e To establish the main points of clinical trials of HIV detection reagents , including tbe 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 f1uid 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 metbod 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. [Key words) HIV; Clinical trias 人类免疫缺陷病毒(human immunodeficiency 析的试剂。[1] Vln风HIV) 生物学标记物是