This kit is intended for use in determining the presence of NS/0 host cell protein contamination in products manufactured by recombinant expression in NS/0 cells. The kit is for Research and Manufacturing Use Only and is not intended for diagnostic use in humans or animals.
- Store Standards at ≤ -20°C. All other reagents should be stored at 2°C to 8°C for stability until the expiration date printed on 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. 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 ~0.8 ng/mL in the Standard Assay Protocol and 300 pg/mL in the High Sensitivity Protocol.
The lower limit of quantitation (LOQ) is defined as the lowest concentration, where concentration coefficients of variation (CVs) are <20%. The LOQ is ~3 ng/mL in the Standard Assay Protocol and ~1ng/mL in the High Sensitivity Protocol.