AccuSignal™ E. coli HCP ELISA Kit

AccuSignal™ E. coli HCP ELISA Kit is a robust sandwich enzyme-linked immunosorbent assay (ELISA) designed to detect contaminating E. coli HCPs in therapeutic products throughout their purification processes, including early, mid, late, and final stages. Additionally, it can detect HCPs from both B and K-12 E. coli strains, which are commonly employed in the biomanufacturing of drug substances.

E. coli HCPs from a sample are captured on the AccuSignal™ E. coli HCP ELISA Kit plate, which is coated with pre-immobilized anti-E. coli HCP antibodies. The detection antibodies included in the kit, also anti-E. coli HCP antibodies, are conjugated with Horse Radish Peroxidase (HRP). When exposed to the substrate 3,3’,5,5’-Tetramethylbenzidine (TMB), HRP is activated, leading to a color change that can be quantified using a plate reader set to 450 nm. The resulting optical density (OD) value is directly proportional to the concentration of E. coli HCPs present, which can be determined by interpolating against a Four-Parameter Logistic (4PL) standard calibration curve.