This kit is intended for use in determining the presence of MRC5 host cell protein contamination in products manufactured by recombinant expression in MRC5 cells. 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.
* The substrate reagent should not be used if its stopped absorbance at 450nm is greater than 0.1.
* 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 is ~1.8 ng/mL.
The lower limit of quantitation (LOQ) is defined as the lowest concentration, where concentration coefficients of variation (CVs) are <20%. The LOQ is ~5 ng/mL.