This kit is intended for use in determining the presence host cell protein contamination in products manufactured by expression in MDCK host cells. The kit is for Research and Manufacturing Use Only and is not intended for diagnostic use in humans or animals. Users should qualify this assay for use with their product samples.
- All reagents should be stored at 2°C to 8°C for stability until the expiration date printed on the kit.
- Reconstituted wash solution is stable until the expiration date of the kit.
- After prolonged storage, you may notice a salt precipitate and/or yellowing of the wash concentrate. These changes will not impact assay performance. To dissolve the precipitate, mix the wash concentrate thoroughly and dilute as directed in the 'Preparation of Reagents' section.
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 is 0.5 ng/mL.
The lower limit of quantitation (LOQ) is defined as the lowest concentration, where concentration coefficients of variation (CVs) typically are <20%. The LOQ is 1.5 ng/mL.