DESCRIPTION

Used for the quantitative determination of HEK293 HCP concentration in biological products derived from HEK 293 and HEK 293F cell lines.

PRINCIPLE OF THE ASSAY

This assay employs the quantitative sandwich enzyme immunoassay technique. An antibody specific for HEK293 HCP has been pre-coated onto a microplate. Standards or samples and a biotin-labeled antibody specific for HEK293 HCP are pipetted into the wells, standards or HEK 293 HCP in the samples form immunocomplex with immobilized antibody and biotinylated anti-HEK 293 HCP antibody. After washing away any unbound substances, Streptavidin-HRP is added to the wells. Following a wash to remove any unbound enzyme reagent, a substrate solution is added to the wells and color develops in proportion to the amount of HEK293 HCP bound in the initial step. The color development is stopped and the intensity of the color is measured.

PRECISION

Intra-Assay Precision (Precision within an assay): <20% Three samples of known concentration were tested sixteen times on one plate to assess intra-assay precision. Inter-Assay Precision (Precision between assays): <20% Three samples of known concentration were tested in twenty four separate assays to assess inter-assay precision.

RECOVERY

LINEARITY