【摘要】 目的:建立一种特异、敏感的临床C肽的化学发光免疫分析诊断方法并应用于临床。方法:采用特异性的两株C-P单克隆抗体,辣根过氧化物鲁米诺酶促增敏化学发光体系,利用双抗体夹心法检测。结果:敏感度为0.02μg/L;检测线性范围为0.02~20μg/L;多人次检测证实试剂盒批内变异均小于10%,分析间变异小于15%;与18μg/L人胰岛素原、2 000 m IU/L的人胰岛素无显著交叉反应。结论:该方法灵敏度高,特异性好,稳定性强,检测范围宽,有良好的准确性和重复性,适合应用于临床。更多还原

【Abstract】 Objective:To establish chemiluminescence quantitative immunoassay for determination of C-Peptide based on the direct sandwich technique.Methods:A sandwich CLIA kit for detection of C-Peptide was developed.Two kinds of monoclonal antibody to human C-Peptide and HRP luminal luminescent enhancement system were obtained.Results:The sensitivity of the developed method was 0.020 μg/L.Its measurement range was 0.02~20 μg/L.There was no significant cross-reaction with(2 000) mIU/L insulin and 18 μg/L proinsulin.The intra-and inter-assay coefficients of variation were 10% and 15%,respectively.Conclusion:The developed C-Pep tide CLIA method in this study is suitable for clinical application with fine sensitivity,specificity and accuracy correspond to related laboratory criteria and may substitute for foreign products.更多还原