免疫胶体金技术效能评价  

THE EVALUATION OF DOT-IMMUNOGOLD FILTRATION ASSAY

作　　者：邢颜超[1] 程维兴[1] 路西春[1] 陈红[1] 孔江 黄永莉[1] 

机构地区：[1]兰州军区乌鲁木齐总医院输血科,乌鲁木齐830000

出　　处：《解放军预防医学杂志》2004年第2期97-100,共4页Journal of Preventive Medicine of Chinese People's Liberation Army

摘　　要：目的对 3种免疫胶体金技术 (DIGFA)检测试条 (卡 )检测乙型肝炎病毒表面抗原(HBsAg)、丙型肝炎病毒抗体 (抗HCV)、梅毒螺旋体抗体 (抗TP)和艾滋病病毒抗体 (抗HIV)的性能进行评价 ,为各血液中心传染病检测实验室选用提供参考。方法对多份质控血清和 4 2 1 4份患者血清或血浆分别采用 3个厂家的DIGFA试条 (卡 )和酶免疫法 (EIA)进行检测 ,以EIA技术为参照 ,对DIGFA试条 (卡 )的灵敏度、特异性、检测效率和物理性能等参数进行评价。结果多份质控血清 4个项目DIGFA试条 (卡 )检测特异性均为 1 0 0 % ,HBsAg、抗HIV、抗HCV和抗TPDIGFA试条 (卡 )检测的灵敏度分别为 86 .6 7%、93.33%、86 .6 7%和 90 .4 7% ;检测效率分别为 91 .1 1 %、96 .6 7%、93.33%和 94 .4 5 %。 4 2 1 4份患者血清 (血浆 )的HBsAg、抗HIV、抗HCV和抗TPDIGFA试条 (卡 )的检测特异性分别为 99.6 7%、99.76 %、99.5 6 %和 99.79% ;灵敏度分别为 6 8.35 %、1 0 0 .0 0 %、5 6 .4 1 %和 73.33% ;检测效率分别为 97.6 0 %、99.76 %、98.77%和 99.6 9%。结论DIG FA试条 (卡 )检测灵敏度比较低 ,花费成本较大。该技术可用于急诊病人的初步筛选 ,不适于献血员筛选试验。Objectives To evaluate the quality and performance of dot-immunogold filtration assay(DIGFA) strips or cards from 3 factories for HBsAg,Anti-HIV,Anti-HCV,Anti-TP detection and to provide reference basis for infectious disease detecting laboratories of blood centers to select these assay methods. Methods Several known quality control blood sera and 4 214 unknown patient blood sera or plasmas were tested by both DIGFA strips/cards and EIA.The sensitivity ,specificity,physical properties and test efficiency of the strips/cards were assessed. Results In several known quality control blood sera, the test specificity, sensitivity, and efficiency for HBsAg,Anti-HIV, Anti-HCV and Anti-TP were found to be 100%, 100%, 100%, 100%, and 86.67%, 93.33%, 86.67%, 90.47%, and 91.11%, 96.67%, 93.33, 94.45% respectively.In 4 214 unknown patient blood sera or plasmas, the test specificity, sensitivity and efficiency for HBsAg, Anti-HIV, Anti-HCV and Anti-TP were 99.67%, 99.76%, 99.56%, 99.79%, and 68.35%, 100.00%, 56.41%, 73.33%, and 97.60%, 99.76%, 98.77%, 99.69 respectively. Conclusions DIGFA is less sensitive and more expensive than EIA. It may be used for emergency patient's first screening but not suitable for screening of blood donors.

关 键 词：免疫胶体金技术 乙型肝炎病毒表面抗原 丙型肝炎病毒抗体 梅毒螺旋体抗体 艾滋病病毒抗体 效能评价 

分 类 号：R446.6[医药卫生—诊断学]