胶体金免疫层析试纸检测乙型肝炎病毒表面抗原的评价

Evaluation of Colloidal Gold Immunochromatography Paper Test for HbsAg Detection

目的 :对四种胶体金免疫层析测定 (GICA)试纸条检测乙型肝炎病毒表面抗原 (HBsAg)进行评价 ,以此为实验室选择提供依据。方法 :采用GICA法和酶免疫 (ELA)法对定值的HbsAg样品和 12 10份病人血清标本同时测定 ,测定其敏感性、特异性和物理特性。结果 :四种GILA对表面抗原的最小检出量为 1～ 5ng/ml。与ELA法比较检出率为 92 7%～99 1%,未发现假阳性及前带现象。结论 :GICA检测血清中HbsAg敏感性低于ELA法 ,成本较高 ,但特异性强 ,简便快速 ,无需特殊仪器设备 ,适用急诊和献血员的现场采血前的筛选 ,有一定的应用价值。

Objective: To evaluate the quality and performance of 4 sources of gold immunochromatography assay (GICA) strips for HbsAg detection in order to provide advice for various laboratories in the selection of HbsAg assay kits. Methods: QC known sera and 1210 patients sera were tested with both GICA strips and ELA.The sensitivity, specificity and physical properties of the strips were assessed. Results: The minimal detection limit of the 4 sources of GICA strips was 1-5 ng/ml. Compared with ELA, detection rates varied from 92.7 to 99.1% and no false positives and pre-band of GICA strip assay were found. Conclusinos: GICA is fit for emergency test and rapid screening of blood donors, although it is less sensitive than ELA and costs more.