人血清胱抑素C化学发光免疫分析检测系统的建立

摘要

Objective To construct chemiluminesce immunoassay(CLIA) system for the detection of serum Cystain C(Cys C). Methods Polyclonal and monoclonal antibody specific for human Cys C were prepared. Microwell was coated by monoclonal antibody. Polyclonal antibody was labeled with horse radish peroxidase CHRP). CLIA system, based on sandwich method, was constructed, evaluated and compared with Roche MDDULAR P800 system. Results The constructed CLIA system was with linear range of 0. 05 - 20 mg/L, sensitivity of 0. 05 mg/L, correlation coefficient of 0. 999 7 for standard curve and within-run and between-run coefficient of variability less than 5%. The correlation coefficient between constructed system and Roche MDDULAR P800 system was 0. 980 2. Conclusion CLIA system for the detection of human Cys C was successfully constructed with high sensitivity,fine precision and stability,and might be suitable for clinical application.%目的 建立可用于人血清胱抑素C(Cys C)检测的化学发光免疫分析(CLIA)系统.方法 制备抗人Cys C多克隆及单克隆抗体,以单克隆抗体包被发光板,以辣根过氧标记多克隆抗体作为游离抗体,以夹心法为检测原理,建立Cys C CLIA检测系统;对自建检测系统进行方法 学评价,并与罗氏MODULAR P800颗粒增强透射免疫分析(PETIA)系统进行比对.结果 自建CLIA检测系统线性范围为0.05~20 mg/L,灵敏度为0.05 mg/L,标准曲线线性相关系数为0.999 7,批内、批间变异系数均小于5%;与罗氏MODULAR P800 PETIA检测系统检测结果 的相关系数为0.980 2.结论 成功建立人血清Cys C CLIA检测系统,该检测系统灵敏度高、精密度好、稳定性高,能够满足临床应用要求.