Protein A purification medium is widely used in the production process of antibody drugs because of its specific adsorption to most antibodies. Protein A is bound to the purification medium through covalent bonds, but Protein A has a certain probability of shedding during the purification process and remains. Protein A ELISA Kit is an ELISA kit that can accurately quantify residual Protein A in samples and can be used for process optimization during antibody purification, evaluation of critical quality parameters, and detection of Protein A residues in intermediate and final products. This kit applies the experimental principle of double antibody sandwich enzyme-linked immunosorbent assay (ELISA) to detect the residue of Protein A. Protein A standard (36716-B) and the sample to be tested are added to Protein A capture microwell strip (36716-A) pre-coated with anti-Protein A antibody, then diluted Biotin-labeled Protein A detection antibody (36716-C), and finally Streptavidin-HRP (SA-HRP) (36716-D) are added to form antibody + antigen + antibody-Biotin + SA-HRP complex. After washing the plate, add TMB color development solution (36716-F) to develop color. TMB was converted from colorless to blue under the catalysis of HRP enzyme and finally to yellow under the action of stop solution (36716-G). The depth of yellow color is positively correlated with the amount of Protein A detected in the sample. The detection range of this kit is 15.625~1000 pg/mL; the lower detection limit is 5.6 pg/mL. Validation Report Feature Highly sensitive: Detecting as little as 5.6 pg/mL of Protein A residuals in in-process and final biological samples. Ensures accuracy: The Protein A residuals can be accurately detected with a recovery of 75%-125%. Specificity: Specific detection of Protein A without interference from other exogenous proteins. Stable: The difference between lot-to-lot is low, the kit property is not impacted under 37℃ for 7 days. Easy signal collection: Using Biotin-Streptavidin system, the signal can be stably enlarged. Application Residual Protein A test in biological products Specification Sensitivity 5.6 ng/mL (range 15.625~1000 pg/mL) Assay Time
