HIV抗体快速检测试剂的临床评价  

Clinical evaluation of HIV-1/2 antibody rapid tests

作　　者：李秀华[1] 宋爱京[1] 王佑春[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中华实验和临床病毒学杂志》2006年第3期279-281,共3页Chinese Journal of Experimental and Clinical Virology

基　　金：国家"十五"科技攻关项目(2004BA71907)

摘　　要：目的对注册前的HIV抗体快速检测试剂的质量进行临床评价。方法用不同的评价试剂检测440份健康献血员样品、300份HIV抗体强阳性样品以及264份HIV感染高危人群样品，并分别计算其特异性和敏感性。结果17家注册前试剂检测300份HIV抗体强阳性样品的敏感性为100％；检测440份健康献血员样品的特异性为97．7％-100％；检测264份HIV感染高危人群样品的特异性为59．1％-100％，敏感性为70．3％-95．1％。结论不同试剂之间存在敏感性和特异性的差异，而且HIV感染的高危自然人群来源的样品有助于客观地反应试剂的质量差异。Objective To evaluate the sensitivity and specificity of HIV-1/2 antibody rapid tests prior to licensing. Methods Four hundred forty, 264 and 300 blood samples were collected from normal blood donors, drug addicted individuals and HIV infected patients, respectively. All the samples were tested with 17 kinds of HIV-1/2 antibody rapid tests prior to licensing. The sensitivity and specificity of each test were calculated. Results The sensitivity for all evaluated rapid tests was 100% for detecting 300 strong positive samples for HIV antibody; the specificity for all evaluated rapid tests was within the range of 97.7%-100% for detecting 440 samples from normal blood donors; the sensitivity and specificity of all tests were within the range of 70.3 %-95.1% and 59.1%-100 % respectively for detecting 264 samples from HIV high risk population. Conclusion The sensitivity and specificity of different tests were different and the samples from HIV high risk population may be very useful for evaluation of the quality of HIV-1/2 antibody rapid tests.

关 键 词：HIV 抗体 病毒 快速试剂 质量 

分 类 号：R446.6[医药卫生—诊断学]