title: Most commercial insulin assays fail to detect recombinant insulin analogues.
abstract: Insulin assays are utilized in various clinical scenarios, including the assessment of insulin therapy compliance or of suspected insulin overdose. In an interpretative exercise carried out by UK National External Quality Assessment Service (NEQAS), serum sent to the participating laboratories was spiked with 30 pmol/L of the short-acting insulin analogue Human Actrapid. Only two out of 24 participant laboratories had sufficient assay cross-reactivity with Actrapid to interpret the results as suggestive of insulin administration. The development of specific insulin assays has led to deterioration in the ability to detect non-compliance or overdose with recombinant insulin treatment. Clinicians should be aware of this significant limitation, which could lead to misdiagnosis.
authors.affiliation: Department of Diabetes and Endocrinology, University of Manchester, Salford Royal Hospitals University Trust, Hope Hospital, Stott Lane, Salford, Greater Manchester M6 8HD, UK. aheald@fs1.ho.man.ac.uk
authors.forename: A H
authors.initials: AH
authors.lastname: Heald
authors.forename: B
authors.initials: B
authors.lastname: Bhattacharya
authors.forename: H
authors.initials: H
authors.lastname: Cooper
authors.forename: A
authors.initials: A
authors.lastname: Ullah
authors.forename: A
authors.initials: A
authors.lastname: McCulloch
authors.forename: S
authors.initials: S
authors.lastname: Smellie
authors.forename: G
authors.initials: G
authors.lastname: Wark
mesh_terms: D000293:Adolescent; D002624:Chemistry, Clinical / Q000379:methods*; D003920:Diabetes Mellitus / Q000097:blood* / Q000175:diagnosis; D006801:Humans; D007328:Insulin / Q000032:analysis* / Q000627:therapeutic use*; D061389:Insulin, Regular, Pork; D008297:Male; D015337:Multicenter Studies as Topic; D011994:Recombinant Proteins / Q000032:analysis*; D015203:Reproducibility of Results
chemical_list: D007328:Insulin; D061389:Insulin, Regular, Pork; D011994:Recombinant Proteins; C000006:insulin, neutral