New ways for the standardization of autoantibody assays: chimeric monoclonal antibodies.

Recombinant production of human autoantigens and new assay methodologies have created new opportunities for the detection of autoantibodies in autoimmune disease situations. However, the standardization of test results remains unsatisfactory which can be traced to supply and batch variation problems of the patient sera used as standard materials. Human monoclonal autoantibodies can be used as novel standards, but are difficult to generate and produce routinely. We present a strategy based on atransgenic mouse strain producing chimeric human IgG1 antibodies after immunization. Together with traditional mouse hybridoma technology this approach allows creation of large panels of chimeric monoclonal autoantibodies for standardization purposes.