一种用于检测人血清中骨钙素的化学发光免疫分析法及“钩状效应”的解决方案。

A Chemiluminescent Immunoassay for Osteocalcin in Human Serum and a Solution to the "Hook Effect".

作者信息

Han Shuang, Xue Yifeng, Zhang Junlan, Huang Jianrong, Liu Xiuxia, Yang Yankun, Bai Zhonghu, Wang Chunxin

机构信息

The Key Laboratory of Carbohydrate Chemistry and Biotechnology, Ministry of Education, School of Biotechnology, Jiangnan University, Wuxi 214122, China.

National Engineering Laboratory for Cereal Fermentation Technology, Jiangnan University, Wuxi, China.

出版信息

J Anal Methods Chem. 2020 Dec 9;2020:8891437. doi: 10.1155/2020/8891437. eCollection 2020.

DOI:10.1155/2020/8891437

PMID:33376621

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7744234/

Abstract

A chemiluminescent immunoassay for human serum osteocalcin, or bone Gla protein, was established using a double-antibody sandwich model. Examination of the hook effect revealed that it was significantly reduced, and no hook effect was observed at an osteocalcin concentration of 4000 ng/mL. The established method showed good analytical performance and thermal stability. The limit of detection was 0.03 ng/mL. The intra-assay coefficient of variation (CV) was 3.22%-5.64%, the interassay CV was 4.42%-7.25%, and the recovery rate was 93.22%-107.99%. Cross-reactivity (CR) was not observed with bovine, rat, mouse, rabbit, or porcine samples. The developed method showed a good correlation with the N-MID product from Roche. In total, 1069 clinical patient samples were measured using the reagent kit developed in this study.

摘要

采用双抗体夹心模型建立了人血清骨钙素（即骨γ-羧基谷氨酸蛋白）的化学发光免疫分析方法。对钩状效应的检测表明，其显著降低，在骨钙素浓度为4000 ng/mL时未观察到钩状效应。所建立的方法具有良好的分析性能和热稳定性。检测限为0.03 ng/mL。批内变异系数（CV）为3.22%-5.64%，批间CV为4.42%-7.25%，回收率为93.22%-107.99%。未观察到与牛、大鼠、小鼠、兔或猪样本的交叉反应（CR）。所建立的方法与罗氏公司的N-MID产品具有良好的相关性。总共使用本研究开发的试剂盒检测了1069份临床患者样本。