胶体金免疫层析法检测尿hCG的质量控制方法探讨

目的通过对胶体金免疫层析法（GICA）试纸条评价,建立该方法的检测尿hCG的室内质控.方法利用hCG不同浓度的标准品评价试纸条的敏感性、重复性、稳定性、检测范围,检测温度及时间对试纸条检测尿hCG结果的影响等.结果GICA的检测范围25-100万mlU/ml,最低检出限达25mIU/ml,大于200万mIU/ml时存在后带现象.试纸条反应5分钟后呈色均一,最佳检测温度为4-30℃.结论灵敏度检测可作为GICA室内质控的主要指标,它能保证检测结果的准确性.

Interior quality control of urinary human chorionic gonadotrophin test by golden immunochromatorgraphy assay

Objective To set up interior quality control of urinary human chorionic gonadotrophin(hCG) test by golden immunochromatography assay (GICA).Methods The sensitivity,repetition,stability,and detectable range of hCG Diagnostic Kit(Colloidal Gold) were evaluated with hCG standard.Meanwhile the effect of detective temperature and time on urinary hCG test by the kit were assessed.Results The lowest detectable level of hCG in urine was 25 mlU/ml,and its detectable range was wide.However there was zone phenomena.The repetition and stability were favorable.Detective temperature and time impact slightly on the test.Conclusion To develop interior quality control of GICA using the quality indexes including sensitivity,repetition,and stability will ensure the accuracy of the results.