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.
出处
《解放军预防医学杂志》
CAS
北大核心
2004年第2期97-100,共4页
Journal of Preventive Medicine of Chinese People's Liberation Army
