This kit was developed using broadly reactive polyclonal antibodies to the hundreds of different HCPs and is intended for use in determining the presence of E.coli host cell protein contamination in products manufactured by recombinant expression. Our assay validation has determined that the LOD for this kit is ~0.2ng/mL.
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.
Limit of Detection (LOD) - The E. coli HCP concentration corresponding to an OD signal 2 standard deviations above the mean of the zero standard is defined as the LOD. This was determined from 10 replicates of the zero standard. The mean signal of the zero standard plus 2 SD yielded a LOD of 200 pg/mL.