Engineered human antibodies as immunologic quality control reagents.

This study demonstrates the utility of a panel of genetically-engineered human-mouse chimeric antibodies with variable region specificity for a hapten, NP, and constant regions analogous to the different human immunoglobulin isotypes as quality control reagents. They performed well as isotype-restricted human immunoglobulin proteins to test the specificity to total serum Ig immunoenzymetric assays and as antibodies to validate selected conjugated reagents used in human antibody immunoassays. The chimeric antibodies studied have several advantages over human paraproteins as quality control reagents for clinical assays. They possess single isotypes, are free of other human immunoglobulin isotypes, can be produced in large quantities in cell culture, and have a defined specificity for NP, an antigen that can be conjugated to BSA and isolubilized on most solid phase surfaces.