Proinsulin level in diabetes mellitus measured by a new immunochemiluminometric assay.

Proinsulin, the precursor of insulin and C-peptide, is detectable in the circulation and is a potential marker of beta-cell dysfunction. Currently, circulating proinsulin can be measured accurately without the interference of insulin or C-peptide by immunometric assays and a few specific radioimmunoassays. An immunochemiluminometric assay was developed in our laboratory by using two immunopurified polyclonal antibodies of C-peptide and insulin from two goats. The C-peptide antiserum was labeled with acridinium ester. The insulin antiserum was immobilized onto a plastic bead. With this assay, proinsulin levels found in noninsulin-treated patients with noninsulin-dependent diabetes mellitus (63 +/- 58 pmol/L; n = 19) were significantly higher (p < 0.05) than levels in insulin-treated patients with noninsulin-dependent diabetes mellitus (30 +/- 24 pmol/L; n = 43), and both were significantly higher (p < 0.001) than proinsulin levels in patients with insulin-dependent diabetes mellitus. In addition, there was a negative correlation between proinsulin levels and duration of years on insulin therapy in patients with noninsulin-dependent diabetes mellitus (r = -0.4795; p < 0.01).