胶体金免疫层析技术检测HBsAg临床应用评价

The Quality Analysis and Application of Dot-immuogold Filtration Assay for HBsAg

目的 对三种免疫胶体金层析技术 (DIGFA)检测试条检测乙型肝炎表面抗原 (HBsAg)的性能、结果等技术参数进行评价。方法 对多份质控血清和 4 2 14份患者血清或血浆分别采用三个厂家的DIGFA试条和酶免疫法 (EIA)进行检测 ,以EIA技术检测结果为参照对DIGFA检测试条的灵敏度、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HBsAgDIGFA试条检测特异性均为 10 0 % ;HBsAgDIGFA试条A ,B ,C检测的灵敏度分别为 90 .0 0 % ,90 .0 0 %和80 .0 0 % ;A ,B ,C三种检测试条检测效率为分别为 93.33% ,93.33%和 86 .6 7%。 4 2 14份患者血清 (血浆 )的HBsAgDIGFA试卡检测特异性为 99.6 7% ;灵敏度为 6 8.3% ;检测效率为 97.6 0 %。结论 DIGFA试条检测灵敏度比较低 ,花费成本较大。该技术适合急诊病人的初步筛选 ,不适于献血员筛选试验。如果应用到街头 (采血车 )献血员快速筛选 。

Objective To evaluate the quality and performance of 3 sourcos of Dot-immuogold filtration assay (DIGFA) calories and EIA kits for HBsAg, detcetion and to provide data for various laboratories of blood center in the selection of HBsAg assay methods.Methods Several known quality contro1 blood serums and 4 2l4 unknown blood serums or blood plasms of patients were tested by both DIGFA ca1ories and EIA. The sensitivity, specificity, physical proportics and agreement of the calories were assessed.Results In several known quality control blood serums, The specificity of HBsAg were foun to be l00%, The sensitivity of HBsAg was 90.00% and 90.00% and 80.00% respectively, The efficiency of HBsAg was 93.33% and 93.33% and 86.67% respectively. In 4 2l4 unknown blood serums or blood plasms of patients, The specificity, sensitivity and efficiency of HBsAg wns found to be 99.67% and 68.35% and 97.60%. Conclusion DIGFA is less sensitive than EIA, and costs more. It is fit for emergency and is not fit for rapid screening of blood donors.In blood donors rapid screening, DIGFA should be combined with EIA, since screening only by DIGFA may not be reliable.