艾滋病病毒抗体诊断试剂临床质量评估  

Evaluation of screening reagents for detecting antibodies of human immunodeficiency virus

作　　者：刘琪琛[1] 杨旭[1] 

机构地区：[1]张家口市疾病预防控制中心,河北张家口075000

出　　处：《现代预防医学》2013年第10期1947-1948,共2页Modern Preventive Medicine

摘　　要：目的对市场上销售的5种HIV抗体诊断试剂的质量进行评估。方法使用5种酶联免疫(ELISA)试剂检测200份血清标本中HIV抗体,其中包括100份已知结果样本和100份高危人群血清标本,并对可疑样本进行WB确证。结果 5种试剂的敏感性、特异性、假阳性率、假阴性率、功效率、阳性预示值(PPV)、阴性预示值(NPV)分别在97.33%～98.67%、97.60%～99.20%、0.8%～2.4%、1.33%～2.67%、97.50%～99.00%、96.05%～98.67%、98.39%～99.20%范围内。结论艾滋病毒抗体检测试剂质量参差不齐,试剂质量需进一步提高。OBJECTIVE To evaluate five screening reagents which were used in Zhangjiakou for detecting antibodies of HIV. METHODS Five elisa screening reagents were used to detect the samples, including 100 known samples and 100 unknown samples. And suspicious samples were conformed by WB test. RESULTS The sensitivities of all the screening reagents were ranged from 97.33%-98.67%, the specificities 97.60%-99.20%, the total consistence rates 97.50%-99.00%, the false positive rates 0.8%-2.4%, the false negative rates 1.33%-2.67%, the PPV 96.05%-98.67% and the NPV 98.39%-99.20%. CON- CLUSION There is wide gap among all of reagents. In a word, the quality of reagents made in China should be further im- proved.

关 键 词：艾滋病病毒 抗体 试剂 质量评估 

分 类 号：R446.6[医药卫生—诊断学] R512.91[医药卫生—临床医学]