This E. coli HCP 2nd Generation ELISA Kit, Item Number F1020, will be replacing the current E. coli HCP ELISA Kit, Item Number F410. Cygnus has manufactured, characterized, and qualified large pools of the new reagents that will replace the current reagents. The antibodies were generated against and affinity purified using mild lysate from a number of widely used E. coli strains, the same way as the original critical reagents in the F410 Kit. The coverage of the new antibodies to the E. coli HCP antigen was determined to be ~87-88% by Antibody Affinity Extraction with Mass Spectrometry (AAE-MS). More importantly, Cygnus Technologies has demonstrated the equivalency of the new antibodies (F1022-AF) in the E. coli HCP ELISA, 2G (F1020) using a panel of E. coli samples from a number of independent biomanufacturing processes. This new Cygnus Technologies' E. coli HCP ELISA Kit, 2G provides the specificity and sensitivity (LOD ~0.3 ng/ml, LLOQ ~3 ng/ml) to detect HCPs with reproducibility that supports regulatory compliance, aiding in optimal purification process development, process control, routine quality control, and product release testing. Please use Sample Diluent, Item No. I028, with these kits; available separately.
Important Change Notification Memo: E. coli HCP ELISA Kit, 2G