【摘要】 目的研制人C肽(C peptide)时间分辨免疫荧光分析(TRFIA)试剂盒。方法采用双抗体夹心一步法建立C肽TRFIA试剂盒,对试剂盒的各项指标进行评价。结果试剂盒的可测范围为0.5～22ng/ml,灵敏度为0.045ng/ml,批内、批间的变异系数(CV)分别为4.1%～6.7%和5.4%～6.8%;与胰岛素无交叉反应,与胰岛素原的交叉反应率为9.0%。30份血样用本试剂盒与国外同类试剂盒同时检测,其相关系数为0.992。结论试剂盒各项指标均达到临床检测要求,可替代国外同类产品试剂盒。更多还原

【Abstract】 Objective To prepare a time-resolved fluoroimmunoassay (TRFIA) kit for detection of human C-peptide.Methods A sandwich TRFIA kit for detection of C-peptide was developed using monoclonal antibody to human C-peptide.Results The measurement range of the developed kit was 0.5-22 ng/ml.Its sensitivity was 0.08 ng/ml.There was no cross-reaction with insulin and the cross reactivity rate with proinsulin was 9%.The intra-and inter-assay coefficients of variation were 4.1-6.5% and 5.4-6.8% respectively.The correlation coefficient between home-made and commercially available C-peptide kit (PerKin Elmer) for the results of blood samples was 0.992.Conclusion The developed C-peptide TRFIA kit in this study was available for clinical application with fine sensitivity, specificity and accuracy correspond to related laboratory criteria and may substitute for foreign like products.更多还原