Preparation of time-resolved fluoroimmunoassay kit for detection of human C-peptide

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.