The E.coli|360-HCP ELISA is an enhanced generic host cell protein (HCP) assay. It was designed to cover a broader spectrum of E.coli host cell proteins (HCPs) than other commercially available generic HCP assays.
E.coli|360-HCP ELISA is based on W3110 and BL21 (DE3) cell lines which were fermented in different culture media and conditions resulting in several antigen preparations with distinct HCP patterns. By immunizing goats (type C) or rabbits (types A, D and E) with these antigens, BioGenes has developed a panel of different HCP ELISAs kits that together build up the enhanced generic E.coli|360-HCP ELISA.
High specificity of the antibody preparations was demonstrate by coverage of ≥ 80% of the respective E.coli|360-HCP antigen distribution. Antigen coverage was measured by a 2D Western blot with Cy5-labeled E.coli|360-HCP standard and the corresponding Cy3-labeled anti-HCP antibodies.
Satisfying recovery was estimated in spiked samples within the assay working range within the acceptance criterion 100±30% of spiked antigen. High sensitivity of E.coli|360-HCP ELISA kits, described by the validation parameter LOD, LOQ and working range, is shown below:
- LOD: 0.2 – 0.5 ng/mL
- LOQ: 0.6 – 1.6 ng/mL
- Working range: 2 – 100 ng/mL