The Quantikine Human Proinsulin Immunoassay is a 4.5 hour solid-phase ELISA designed to measure human Proinsulin in serum and plasma. It contains E. coli-expressed recombinant human Proinsulin and has been shown to accurately quantitate the recombinant factor. Results obtained using natural human Proinsulin showed linear curves that were parallel to the standard curves obtained using the Quantikine kit standards. These results indicate that this kit can be used to determine relative mass values for naturally occurring human Proinsulin.

Intra-Assay Precision (Precision within an assay) Three samples of known concentration were tested twenty times on one plate to assess intra-assay precision

Inter-Assay Precision (Precision between assays) Three samples of known concentration were tested in twenty separate assays to assess inter-assay precision. Assays were performed by at least three technicians using two lots of components

The recovery of human Proinsulin spiked to levels throughout the range of the assay in various matrices was evaluated.

To assess the linearity of the assay, samples spiked with high concentrations of human Proinsulin were diluted with Calibrator Diluent to produce samples with values within the dynamic range of the assay.