Immunoassays for denatured protein analytes, particularly HB Alc, and monoclonal antibodies thereto.

摘要

Binding of a particular protein by an antibody reagent involving denaturation of the protein and use of an antibody reagent specific for binding a linear peptide epitope therein. Denaturation by chemical or physical means effectively exposes or enhances the exposure of the linear peptide epitope for binding by the antibody reagent which is preferably raised against a synthetic peptide immunogen. The technique is particularly useful in performing immunoassays for protein analytes, such as a glycosylated protein, in aqueous test samples. Monoclonal antibodies are also provided which are specific for the glucosylated terminal peptide sequence in the beta-subunit of human hemoglobin and are therefore useful in the determination of Hb Alc.