Insulin antibody determination: theoretical and practical considerations.

The immunogenicity of insulin preparations is of both academic and clinical interest. The links between insulin antibodies and insulin allergy, some forms of insulin resistance and injection site lipoatrophy are well-established, but other more subtle metabolic effects require further examination. Contamination with impurities (e.g. proinsulin) has been a major factor in the immunogenicity of conventional bovine insulin preparations but the less frequent, although still detectable, immunogenicity of highly purified porcine and human preparations remains enigmatic. Further work is required to analyse the physico-chemical factors involved, while the genetic control of the immune response to insulin is of fundamental interest.