艾滋病病毒抗体和梅毒螺旋体抗体快速诊断试剂临床应用评价

The Quality Analysis and Application of Dot Immune Gold Filtration Assay for Anti-TP and Anti-HIV

目的 对目前常用的快速诊断试剂卡 (DIGFA)检测梅毒螺旋体抗体 (抗 TP)和艾滋病病毒抗体 (抗 HIV1/2 )的技术参数进行评估。方法 对多份质控血清和 5 863份患者血清或血浆分别采用三个厂家的DIGFA试卡和酶免疫法 (EIA)进行检测 ,以EIA技术检测结果为参照对DIGFA检测试卡的灵敏度、特异性、检测效能和物理性能等参数进行评价。结果 多份质控血清抗 TP和抗 HIV1/2DIGFA试卡检测特异性均为 10 0 % ;抗 TP、抗 HIVI1/2DIGFA试卡检测的灵敏度分别为 80 .0 0 %和 93 .3 3 % ;检测效率分别为 88.44 %和 96.97%。 5 863份患者血清 (血浆 )的抗 TP和抗 HIV1/2DIGFA试卡检测特异性分别为 99.86%和 99.76% ;灵敏度分别为 5 0 .94%和 77.78% ;检测效率分别为99.42 %和 99.69%。结论 DIGFA试卡检测灵敏度比较低 ,花费成本较大。该技术适合急诊病人的初步筛选 ,不适合献血员筛选试验。如果应用到街头 (采血车 )献血员快速筛选 ,必须和EIA技术联合应用。

Objective To evaluate the quality and the performance of three sources' dot immune gold filtration assay (DIGFA) cards for the detection of anti-treponema pallidum (TP) and anti-human immunodeficiency virus (HIV) -1/2 in order to provide various laboratories of blood center with the data for the selection of anti-TP and anti-HIV1/2 assay methods, referring to the results of enzyme immunoassay (EIA) kits test.Methods Several known quality control blood serums and 5 863 unknown blood serums or blood plasms of patients were tested by DIGFA calories and EIA.The sensitivity, specificity, physical properties and agreement of the calories were assessed.Results In the several known quality control serums, the specificity of anti-TP and anti-HIV1/2 was found to be 100%, and the sensitivity of anti-TP and anti-HIV1/2 was 80.00% and 93.33% respectively, and the efficiency was 88.44% and 96.97%. In the 5,863 unknown serums from the patients, the specificity, sensitivity and efficiency of anti-TP and anti-HIV1/2 were as following: 99.86% and 99.76%, 50.94% and 77.78%, 99.42% and 99.69%. Conclusion DIGFA is less sensitive than EIA in addition to higher cost. It is fit for emergency, and not fit for rapidly screening blood donors. In rapid blood donor screening, DIGFA should be combined with EIA because of its unreliability.