国产乙肝表面抗原金标试纸条检测性能的评价

Quality and performance evaluation of gold immunochroma-tography strips for HBsAg detection

目的:对3种国产乙肝表面抗原(HBsAg)胶体金免疫层析法(GICA)试纸条检测性能做初步研究,明确HBsAg金标法检测在临床上的适用性。方法:用临床血标本对3种金标试纸条渗透性、均一性等物理现象作观察,对最低检测下限、特异性、重复性、后带现象进行初步研究。结果:3种G ICA试条对HBsAg的最小检出量可达2.5 IU/L;特异性100%;未发现后带现象。结论:金标法检测HBsAg适合于血站、口岸等的初筛,不宜用于临床上的快速检测。

Objective：To investigate the quality and performance of 3 sources of gold immunochromatography assay （GICA） strips for HBsAg detection and to define the clinical applicability of the GICA strips. Methods ： A few patients blood samples were tested by immunoluminescence analyzer. The minimal detection limits, sp - ecificity, postzone phenomenon and physical properties of the strips were assessed. Results：The minimal detection limits of the 3 sources of GICA strips could reach 2. 5 IU/L. The specificity was 100%. No post phenomenon was found. Conelusion：GICA for HBsAg is suitable for screening test in port, blood -do- nate station etc. But it is not fit for clinical rapid detection.