磁性微粒子化学发光免疫分析法测定人血清中雌三醇

利用化学发光免疫分析(chemiluminescence immunoassay, CLIA)高灵敏度和高特异性的特点, 将磁性微粒子应用于化学发光免疫分析中, 用两种不同的方法对人体血清内的雌三醇(E3)含量进行了测定. 磁性微粒子分别作为固相一抗包被材料和二抗分离剂参与反应. 两种方法检测雌三醇浓度的线形范围均为0.6～60 ng/mL. 其中, 固相一抗法的批内变异及批间变异系数分别小于11%和15%, 回收率为90%～116%, 健全性系数为0.9987. 二抗分离法的批内变异及批间变异系数分别小于8%和10%, 回收率为88%～118%, 健全性系数为0.9974. 两种方法分别与经典板式化学发光法对比, 检测人血清样本, 结果相关性较好, 且磁性微粒子法更为省时、简便, 适于推广应用.

Determination of Estriol in Human Serum by a Chemiluminescence Immunoassay Method Using Magnetic Microparticle

A chemiluminescence immunoassay (CLIA) method of high sensitivity, selectivity and reproducibility for the determination of estriol (E3) in human serum was developed. The magnetic microparticles were used as the second-antibody separation agent and the first-antibody solid-surface, respectively. Under the selected conditions, the two methods with magnetic microparticles as the second-antibody separation agent and the first-antibody solid-surface respectively, showed a calibration curve for E3 both in the range of 0.6～60 ng/mL. In the first-antibody method, the CVs (coefficient of variations) of intra- and inter-assays were less than 11% and 15%, respectively. The recovery was in the range of 90%～116%, and the soundness coefficient was 0.9987. In the second-antibody method, the CVs of intra- and inter-assays were less than 8% and 10%, respectively. The recovery was in the range of 88%～118%, and the soundness coefficient was 0.9974. Compared with the traditional micro-plate CLIA method, both of the proposed methods exhibited less analysis time and labor. The proposed methods have been used to determine E3 in human serum successfully.