Size: 96 T
Sample: Host Cells
Species Reactivity: N/A
Intended Use
This kit is designed to determine the presence of SP 2/0 host cell protein impurities in products made by recombinant expression in SP 2/0 host cells.
Kit Contents
- Anti-SP 2/0 HRP affinity-purified goat antibody conjugated to HRP in a protein matrix with preservative. 1x12mL
- Anti-SP 2/0 Coated Microtiter Strips 12×8-well strips in a bag with desiccant.
- SP 2/0 HCP Standards SP 2/0 HCP Elisa Kit solubilized in preserved human immunoglobulin. Standards at 0, 2, 8, 25, 75 and 200 ng/mL. 1ml/vial
- 0.5M sulfuric acid stop solution. 1x12mL
- TMB Substrate 3,3′,5,5′ Tetramethylbenzidine. 1x12mL
- Concentrated wash (20X) Tris-buffered saline with preservative. 1x50mL
Storage
All reagents should be stored at 2°C to 8°C to be stable until the expiration date printed on the kit. After prolonged storage, you may notice a precipitate of salt and/or a yellowish colour of the wash concentrate. These changes will not affect the performance of the assay. To dissolve the precipitate, mix the wash concentrate well and dilute as directed in the ‘Reagent Preparation’ section. The reconstituted Wash Solution is stable until the expiration date of the kit.
Precision
Within (n=20 replicates) and inter-assay (n=5 assays) precision was determined in 3 groups with low (2 ng/mL), medium (~25 ng/ mL) and high (~75 ng/mL) concentrations. . The %CV is the standard deviation divided by the mean and multiplied by 100.
Sensitivity
- The lower limit of detection (LOD) is defined as the concentration corresponding to a signal two standard deviations above the mean of the zero standards. The LOD is ~1 ng/mL.
- The lower limit of quantitation (LOQ) is defined as the lowest concentration, where the concentration coefficients of variation (CV) are <20%. The LOQ is ~2 ng/mL.
