Insulin antibody determination: Theoretical and practical considerations

Abstract

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. In order to facilitate comparative studies of different insulin preparations and data translation between different laboratories, it is essential that efforts be made to introduce some elements of standardisation in assay techniques, reporting of results and assessment of precision, accuracy and sensitivity. International collaborative laboratory studies have been successful in various other areas of clinical research relevant to diabetes, notably the series of HLA workshops [53] and comparisons of the radioimmunoassay and bioassay of insulin [54, 55] and the radioimmunoassay of C-peptide [56]. It is hoped that present efforts to achieve successful collaboration for insulin antibody determination will harmonise the diverse approaches to the problems which continue to surround the immunogenicity of insulin. © 1983 Springer-Verlag.