The Quantikine® Human IFN-beta Immunoassay is a 4.5 hour solid phase ELISA designed to measure human IFN-beta in cell culture supernates. It contains CHO cell-expressed recombinant human IFN-beta and has been shown to accurately quantitate the recombinant factor. Results obtained using natural human IFN-beta 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 natural human IFN-beta.

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 IFN-beta spiked to levels throughout the range of the assay in various matrices was evaluated.

To assess the linearity of the assay, samples containing high concentrations of human IFN-beta were serially diluted with calibrator diluent to produce samples with values within the dynamic range of the assay.