血清淀粉样蛋白A化学发光免疫检测技术开发

Development of chemiluminescent immunoassay for human serum amyloid A

旨在建立一种灵敏、快速、稳定的血清淀粉样蛋白A(SAA)的检测方法。采用微孔板式定量化学发光法检测人血清中SAA的含量,反应原理为双抗夹心法。建立的化学发光法标准曲线r^2>0.99,线性范围为5~800ng/mL,最低检测限为3ng/mL,批内精密度和批间精密度(CV)分别小于8%和10%,与西门子检测结果相关性较好,r^2为0.98。建立的血清淀粉样蛋白A的检测方法重复性好,线性范围宽,灵敏度高,完全满足临床测定需求。

This paper aims to develop a sensitive, rapid and stable method that can be used in clinical detection of human serum amyloid A. We established a sandwich chemiluminescent immunoassay(CLIA) method to detect human serum amyloid A quantity in blood samples, and its performance was evaluated. The correlation of standard curve was higher than 0.99. The linear range was 5-800 ng/mL . The detection limit of the method was 0.5 ng/mL. Within-run and between-run precision were lower than 8% and 10%, respectively. One hundred and fifty clinical samples were collected to evaluate the methodological consistency between the developed method and Siemens Kit, and the linear regression results showed a great correlation with r 2 higher than 0.98.