胶体金免疫层析试纸检测乙型肝炎病毒表面抗原的评价

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1210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。

Evaluation of Colloidal Gold Immunochromatography Paper Test for HbsAg Detection

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.