The Quantikine® Human IGF-II Immunoassay is a 3.5 hour solid-phase ELISA designed to measure human IGF-II in cell culture supernates, serum, plasma, and urine. It contains E. coli-expressed recombinant human IGF-II and has been shown to accurately quantitate the recombinant factor. Results obtained using natural human IGF-II 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 IGF-II.

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 IGF-II spiked to levels throughout the range of the assay in various matrices was evaluated.

To assess the linearity of the assay, samples containing and/or spiked with high concentrations of human IGF-II were diluted with calibrator diluent to produce samples with values within the dynamic range of the assay.