This kit is intended for use in determining the presence of CHO Host Cell Proteins (HCPs) in products manufactured by recombinant expression in CHO cells. The antibodies used in this kit were generated from HCPs typically found in protein-free conditioned growth media. The kit is for Research and Manufacturing Use Only and is not intended for diagnostic use in humans or animals.
All reagents should be stored at 2°C to 8°C for stability until the expiration date printed.
Reconstituted wash solution is stable until the expiration date of the kit.
The lower limit of detection (LOD) is defined as that concentration corresponding to a signal two standard deviations above the mean of the zero standard. LOD was <100pg/mL.
The lower limit of quantitation (LOQ) is defined as the lowest concentration, where concentration coefficients of variation (CVs) are <20%. The LOQ is ~0.7 ng/mL.