免疫胶体金技术效能评价

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4214份患者血清或血浆分别采用3个厂家的DIGFA试奈(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100％，HBsAg、抗HIV、抗HCV和抗TP DIGFA试条(卡)检测的灵敏度分别为86．67％、93.33％、86．67％和90．47％；检测效率分别为91．11％、96．67％、93．33％和94．45％。4214份患者血清(血浆)的HBsAg、抗HIV、抗HCV和抗TP DIGFA试条(卡)的检测特异性分别为99．67％、99．76％、99．56％和99．79％；灵敏度分别为68．35％、100．00％、56．41％和73．33％；检测效率分别为97．60％、99．76％、98．77％和99．69％。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。

THE EVALUATION OF DOT-IMMUNOGOLD FILTRATION ASSAY

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.