基于免疫层析的CRP定量检测试剂研制

Development of a quantitative CRP test kit with lateral flow method

目的基于免疫层析技术,研制一种C反应蛋白(C reactive protein,CRP)定量检测试剂。方法采用双抗体夹心法,通过严格的原辅料筛选和生产工艺控制研制试剂,用基于光学定量的免疫层析结果判读记录仪进行定量检测,最后进行性能分析和临床试验。结果研制出了定量检测试剂,功能灵敏度≤1 mg/L,CV≤15%,线性范围1~200 mg/L,室温稳定性12个月;经对220份临床样本进行验证,总符合率为98.6%,Pearson相关系数r=0.987,和对照试剂性能无显著性差异。结论基于免疫层析技术,研制出一种操作简便、稳定性好的CRP定量检测试剂,可运用于现场或临床对CRP的快速定量检测。

Objective A kind of quantitative C reactive protein (CRP) test kit was developed with colloidal gold lateral flow method. Method The kit was prepared with double antibody sandwich technology, and by material optimization and strict process control to improve performance. Quantitative assay was realized by a specialized lateral flow reader. The kit performance was evaluated with series of tests and clinical trial. Results The kit was developed with functional sensitivity≤1 mg/L, linear range 1-200 mg/L, CV<15%and with stability of 12 months. 220 samples clinical trial showed 98.6%of coincidence rate. Pearson Correlation coefficient r is 0.987, which showed no significant difference in performance compare with control kit. Conclusion A quantitative CRP test kit was developed with easy to operating and good stability, Which can be used for point of care testing or laboratory testing.