骨钙素快速检测试纸的工艺优化及质量控制研究

Production Process Optimization and Quality Control of Rapid Test Strip for Osteocalcin

骨钙素是一种重要的骨转换标志物,它在血清中的含量可以反应近期骨转换的效率以及成骨细胞活性,对骨质疏松症的诊断及评估疗效有重要意义。本研究构建了一种双纳米金侧流免疫层析试纸条用于定量检测骨钙素,优化了试纸条的制备工艺,并对其性能指标进行了测定,最低检测限为0.5 ng/m L,批内、批间变异系数分别为4.99%~7.12%和4.44%~10.56%,回收率为95.26%~105.9%,37℃加速老化试验结果显示试纸条两个月内稳定性良好,预测常温保质期为半年。此外,对骨钙素检测试纸条进行了质量控制研究,分别对原材料、半成品和成品建立了质控方法和标准,可供其他诊断试剂参考。

Osteocalcin is a serum marker of bone turnover to reflect osteoblast activity and bone formation efficiency,hence it is an important indicator for the diagnosis,treatment and prognosis judgement of osteoporosis.In this study,the author constructed a lateral flow immunoassay based on dual gold nanoparticles connected by biotin-streptavidin system to quantitatively detect osteocalcin.The author optimized the test strip preparation process and tested the performance.The results showed that the minimum detection limit was 0.5 ng/m L,intra-and inter-assay CVs ranged from 4.99%to 7.12%and 4.44%to 10.56%,and the recovery rate was95.26%~105.9%.The 37°C accelerated aging test showed that the test strip has good stability within two months,and the shelf life at room temperature was predicted to be half a year.In addition,a quality control system for osteocalcin test strips has been established,including raw materials,semi-finished products and finished products of test strips.