基于光激化学发光技术开发的多表位检测cTnI的方法

Development of a light initiated chemiluminescent immunoassay for multi-epitope cTnI determination

目的建立一种多表位识别检测人血清心肌肌钙蛋白水平的光激化学发光免疫检测分析方法。方法采用双抗体夹心法,通过多表位识别建立检测人血清中心肌肌钙蛋白水平的方法,评估其分析灵敏度、回收率和批内精密度,并与Siemens（化学发光法）进行比较。结果心肌肌钙蛋白I的分析灵敏度为0.06 ng/ml,回收率为93.43%,批内精密度（CV）为0.62%-1.55%,与化学发光法的符合率好（r=0.99）。结论光激化学发光免疫分析方法多表位测定心肌肌钙蛋白I具有超高灵敏度、精密度和准确性,与化学发光法的符合率较好,适用于临床。

This study performed to establish a light initiated chemiluminescent immunoassay（LICA） for human serum cardiac Troponin I（cTnI） detection with multi-epitope recognition technique. Based on double antibody sandwich immunoassay and multi-epitope recognition technique, the LICA for detecting human serum cTnI concentration was established, whose analytical sensitivity, coefficient of recovery, and within-run precision were evaluated and compared with those of Siemens（CLIA）. Data showed that the analytical sensitivity of LICA was 0.06ng/ml, coefficient of recovery was 93.43%, and within-run precision（CV） was 0.62%-1.55%, which were highly coincided with those of CLIA（r=0.99）. In conclusion, the constructed LICA possesses advantages of good sensitivity,precision, accuracy and coincidence in determining multi-epitope cTnI, thus could be applied for clinical practice.