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.

中文翻译：

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人血清中骨钙素的化学发光免疫分析及“钩效应”的解决方案

使用双抗体夹心模型建立了针对人血清骨钙素或骨Gla蛋白的化学发光免疫分析法。钩效应的检查显示其显着降低，并且在骨钙素浓度为4000 ng / mL时未观察到钩效应。建立的方法显示出良好的分析性能和热稳定性。检测下限为0.03 ng / mL。批内变异系数（CV）为3.22％-5.64％，批间变异系数为4.42％-7.25％，回收率为93.22％-107.99％。在牛，大鼠，小鼠，兔或猪的样品中未观察到交叉反应性（CR）。所开发的方法与罗氏公司的N-MID产品具有良好的相关性。使用本研究开发的试剂盒，总共测量了1069个临床患者样品。