心肌肌钙蛋白I胶体金免疫层析快速检测法的建立

摘要

The objective developed a rapid and simple colloidal gold immunochromatographic assay(GICA)for the detection of cTnI.A colloidal gold immunochromatography test based on the double-antibody sandwich assay for detecting cTnI was developed. Its sensitivity,specificity and stability were evaluated. The results showed the typical detecting time was not more than 10 min per sample. The positive sample produced a positive signal on immunochromatographic strip,whereas the negative one did not.The sensitivity of the test was 1.0 ng/mL.The positive coincidence rate was 97.0% and the negative coincidence rate was 100.0%.The overall coincidence rate between two assays was 98%.The performance of gold-immunochromatography test strip was stable.%为建立一种快速、简单实用的检测心肌肌钙蛋白I的胶体金免疫层析法(GICA),用柠檬酸三钠还原法制备胶体金颗粒,用鼠源抗cTnI单克隆抗体进行胶体金标记,采用胶体金免疫层析技术及双抗体夹心法原理检测心肌肌钙蛋白I,并对该方法进行敏感性、特异性和稳定性分析.结果:该方法能在10 min内完成检测;该试纸条仅与心肌肌钙蛋白I阳性样品发生特异性反应;检测心肌肌钙蛋白I的最低检出质量浓度为1.0 ng/mL;与化学发光免疫分析法(CLIA)对比检测63份临床标本,阳性符合率97.0%,阴性符合率100%,总符合率98%,试纸条性能稳定.