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Insulin Autoantibodies (IgG)

Code:9067

Synonyms
АТ к инсулину.IAAInsulin antibodiesInsulin autoantibodies
IncludesInsulin autoantibodies (IgG)

Analysis details

Methodology

  • Enzyme-linked immunosorbent assay (ELISA)

Expected Turnaround Time

1 day

Special Instructions

  • Avoid smoking for 30 minutes before the blood draw.
  • Review current use of biotin-containing supplements.
  • Stop biotin for at least 72 hours before specimen collection.

How to use

The Insulin Autoantibodies (IgG) test (IAA, insulin antibodies) is used to aid the differential diagnosis of autoimmune type 1 diabetes versus type 2 diabetes in patients who have never received exogenous insulin. In screening or research contexts, it may be used with other islet autoantibodies to estimate near-term risk of type 1 diabetes in first-degree relatives of affected patients, especially in children. This assay should not be used to distinguish autoimmune disease in individuals treated with insulin, as therapy frequently induces anti-insulin antibodies independent of endogenous autoimmunity.

Limitations

Insulin autoantibodies are highly specific serologic markers of autoimmune beta-cell injury in type 1 diabetes. IAA are present in roughly half of patients at or near the time of diagnosis, occur more frequently in young children, and are often the earliest autoantibody detected at higher titers in this age group. Titers may wane over the first months after onset and can become undetectable over time. A negative IAA result does not rule out type 1 diabetes. Diagnostic yield improves when IAA are measured alongside other islet autoantibodies, such as antibodies to glutamic acid decarboxylase and islet cell antigens. In children without hyperglycemia, detection of IAA signifies immune activity rather than established disease; when combined with additional islet autoantibodies, it is associated with higher short-term risk of progression. Prior exposure to exogenous (recombinant) insulin commonly induces anti-insulin antibodies, producing positive results regardless of underlying autoimmunity; therefore, IAA testing is not appropriate for differential diagnosis in insulin-treated patients. Autoimmune thyroid disease, primary adrenal insufficiency, celiac disease, and pernicious anemia frequently co-occur with type 1 diabetes and merit targeted laboratory evaluation when autoimmune diabetes is confirmed.

Reference interval
MinMax
00.9
IndicationsAssessment of suspected autoimmune type 1 diabetes in a patient presenting with hyperglycemia, Risk stratification for type 1 diabetes in first-degree relatives, with emphasis on pediatric relatives

Possible Causes of Abnormal Results

Increased levels

  • exogenous insulin therapy

Decreased levels

  • biotin (high dose)
  • longer disease duration

Specimen Requirements

SpecimenSerum
ContainerGold/Tiger Top (SST, Gel Separator)
Volume0.5 mL (min 0.4 mL)
Storage InstructionsRoom temperature, Refrigerated, Frozen

References

Franke B, Galloway TS, Wilkin TJ. Developments in the prediction of type 1 diabetes mellitus, with special reference to insulin autoantibodies. Diabetes Metab Res Rev. 2005 Sep-Oct;21(5):395-415.

Bingley PJ. Clinical applications of diabetes antibody testing. J Clin Endocrinol Metab. 2010 Jan;95(1):25-33.

Kronenberg H et al. Williams Textbook of Endocrinology. 11th ed. Saunders Elsevier; 2008.

Felig P, Frohman LA. Endocrinology & Metabolism. 4th ed. McGraw-Hill; 2001.