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。
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.
出处
《临床检验杂志》
CAS
CSCD
北大核心
2005年第3期200-202,共3页
Chinese Journal of Clinical Laboratory Science
基金
广州市科学技术局领域专项(创新药物)项目(2004Z1E4021)。
