人类免疫缺陷病毒抗体快速检测试剂的临床评价  

Clinical Evaluation of Rapid Diagnostic Kit for HIV Antibody

作　　者：李秀华[1] 许四宏[1] 李敬云[2] 貌盼勇[3] 王佑春[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]中国人民解放军艾滋病检测确认实验室,北京100071 [3]解放军第302医院病毒科,北京100070

出　　处：《中国生物制品学杂志》2007年第9期679-680,共2页Chinese Journal of Biologicals

基　　金：国家十五攻关课题资助项目(编号2004BA71907);2006年度卫生部艾滋病防治应用性研究项目"艾滋病防治和诊断指标的评价研究"

摘　　要：目的评价人类免疫缺陷病毒(HIV)抗体快速检测试剂检测全血、血清或血浆样品中HIV抗体的敏感性及特异性。方法从不同地区及不同人群中收集全血样品493份,并分离血清,用考核试剂分别检测同一人的全血及血清样品;同时从不同地区及不同人群中收集HIV抗体阳性和阴性血清/血浆样品共1175份,用考核试剂和参比试剂同时检测。结果考核试剂检测493份全血和血清样品的结果一致,HIV抗体阳性为99份;与参比试剂相比,考核试剂检测血清/血浆样品的敏感性为100%,特异性为99.92%。结论该考核试剂与参比试剂的质量相当。Objective To evaluate the sensitivity and specificity of rapid diagnostic kit for HIV antibody in test for HIV antibody in whole blood, serum or plasma samples. Methods Collect 493 whole blood samples from different populations and regions and separate the serum. Test the whole blood and serum samples of the same subject by diagnostic kit to be evaluated. Meanwhile, a total of 1175 HIV antibody positive and negative serum/plasma samples from different populations and regions were tested by the kit to be evaluated,using the reference kit as control. Results Of the 493 subjects,99 were diagnosed as HIV antibody positive by the kit to be evaluated, and the test results of whole blood and serum samples of the same subject were completely consistent. Compared with those of reference kit ,the sensitivity and specificity of kit to be evaluated were 100% and 99.92% respectively. Conclusion The quality of rapid diagnostic kit for HIV antibody to be evaluated was equal to that of reference kit.

关 键 词：人类免疫缺陷病毒 抗体 诊断试剂 敏感性 特异性 

分 类 号：R512.91[医药卫生—内科学] R446.62[医药卫生—临床医学]