Abstract

The objective of this work is to develop and verify the analytical performance of a chemiluminescence immunoassay for the specific sequence β-carboxy-terminal cross-linking telopeptide of type I collagen (β-CTX) in human serum. Two specific monoclonal antibodies (mAb-8A03 and mAb-3D12) with high affinity for β-CTX were selected, and, under optimized conditions, a chemiluminescence immunoassay method (CLIA) for β-CTX was established. The CLIA of β-CTX detected β-CTX in a wide range of 2.0–6000 ng/L. The recovery rate in serum is 95–105%, the specificity is high, and the cross-reaction rate with common easily interfering substances is low (not more than 0.01%). The CLIA correlates well with Roche electrochemiluminescence immunoassay (ECLIA), with a correlation coefficient of 0.9551, which fully meets the requirements of clinical analysis. The developed β-CTX CLIA kit has high sensitivity and good stability. It has the same performance as the commercial Roche ECLIA kit and can be applied clinically.

摘要

这项工作的目的是开发和验证化学发光免疫测定法对人血清中 I 型胶原蛋白 (β-CTX) 的特定序列 β-羧基末端交联端肽 (β-CTX) 的分析性能。选择了两种对β-CTX具有高亲和力的特异性单克隆抗体（mAb-8A03和mAb-3D12），并在优化条件下建立了β-CTX的化学发光免疫分析方法（CLIA）。β-CTX 的 CLIA 检测到 2.0-6000 ng/L 的广泛范围内的 β-CTX。血清回收率为95-105%，特异性高，与常见易干扰物质的交叉反应率低（不超过0.01%）。CLIA与罗氏电化学发光免疫分析（ECLIA）相关性良好，相关系数为0.9551，完全满足临床分析的要求。开发的β-CTX CLIA试剂盒灵敏度高、稳定性好。它具有与商业罗氏ECLIA试剂盒相同的性能，可应用于临床。