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Test Code INAB Insulin Antibodies, Serum

Important Note

Effective 1/12/18

EXPLANATION: To decrease the frequency of test cancellations due to insufficient volume the minimum volume for INAB: Insulin Antibodies, Serum is increasing. The new minimum volume is 1.0 mL.

Reporting Name

Insulin Abs, S

Useful For

Predicting the future development of type 1 diabetes in asymptomatic children, adolescents, and young adults, when used in conjunction with family history, human leukocyte antigen-typing, and other autoantibodies, including glutamic acid decarboxylase (GAD65) and islet cell antigen 2 (IA-2) antibodies

 

Differential diagnosis of type 1 versus type 2 diabetes

 

Evaluating diabetics with insulin resistance in patients with established diabetes (type 1 or type 2)

 

Investigation of hypoglycemia in nondiabetic subjects

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 28 days
  Frozen  28 days
  Ambient  72 hours

Reference Values

≤0.02 nmol/L

Reference values apply to all ages.

Day(s) Performed

Sunday, Wednesday

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

86337

LOINC Code Information

Test ID Test Order Name Order LOINC Value
INAB Insulin Abs, S 60463-7

 

Result ID Test Result Name Result LOINC Value
8666 Insulin Abs, S 60463-7

Interpretation

Seropositivity (≥0.03 nmol/L) in a patient never treated with insulin is consistent with predisposition to type 1 diabetes. Seropositivity is not as informative of type 2 diabetes status as other islet cell antibodies in patients who are receiving (or have received) insulin therapy because this antibody can arise secondary to therapy. It is thought that high levels of insulin autoantibodies might contribute to insulin resistance.

 

A family history of type 1 diabetes, other organ-specific autoimmunity and a diabetes-permissive human leukocyte antigen phenotype strengthens the prediction of type 1 diabetes development. The detection of multiple islet cell antibodies is indicative of the likely development of future type 1 diabetes.

 

In patients presenting with hypoglycemia, the presence of insulin autoantibodies may indicate surreptitious insulin administration or, rarely, insulin autoantibody-related hypoglycemia. The differential diagnosis cannot be made on the basis of insulin autoantibody detection alone. C-peptide and insulin measurements are always required in addition to insulin autoantibody measurements in the diagnosis of hypoglycemia.

Clinical Reference

1. Schernthaner G. Immunogenicity and allergenic potential of animal and human insulins. Diabetes Care. 1993;16 Suppl3:155-165

2. Lernmark A. Type 1 diabetes. Clin Chem. 1999;45(8 Pt 2):1331-1338

3. Eisenbarth GS, Jeffery J. The natural history of type 1A diabetes. Arq Bras Endocrinol Metabol. 2008;52(2):146-155

4. Thomas NJ, Jones AG. The challenges of identifying and studying type 1 diabetes in adults [published online ahead of print, 2023 Sep 20]. Diabetologia. 2023;10.1007/s00125-023-06004-4. doi:10.1007/s00125-023-06004-4

Report Available

3 to 9 days

Method Name

Radioimmunoassay (RIA)