Immunoassays for the Detection of Antibodies to Specific Compounds

The development and validation of qualitative and quasi-quantitative ELISAs for the measurement of antibodies directed against a specific compound, or biological product has become an expertise of Alta Analytical’s Immunochemistry Group. Because each project offers its own set of challenges and requirements, Alta’s project managers work closely with clients to meet their expectations, while keeping a close eye on the requirements for a fully validated assay that will be accepted by the regulatory agencies.

The group has various approaches to the assay format (sandwich ELISA, bridging format), along with a desire to assure the sponsor that the assay has been developed and validated to be not only as sensitive as possible, but also to be a rugged and reliable assay – so that lengthy clinical trials can count on the ability of the assay to perform as reproducibly in year 3 as it did in year 1.