The Quantikine Human ErbB2/Her2 Immunoassay is a 4.5 hour solid-phase ELISA designed to measure human ErbB2 in cell culture supernates, cell lysates, serum, plasma, urine, and human milk. It contains NS0-expressed recombinant human ErbB2 and has been shown to accurately quantitate the recombinant factor. Results obtained using natural human ErbB2 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 ErbB2.

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

Inter-Assay Precision (Precision between assays) Inter-assay Precision (Precision between assays)<br>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 ErbB2 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 ErbB2 were diluted with Calibrator Diluent to produce samples with values within the dynamic range of the assay.