Ordering Recommendation

Determine presence of antibodies to endogenous or exogenous insulin analogues. Testing not recommended for patients receiving insulin >2 weeks, as insulin antibody formation may occur.
If pursuing antibody testing to determine autoimmune diabetes mellitus (DM), perform at least two antibody tests. In most cases, use glutamic acid decarboxylase antibody in combination with another antibody test. Other antibody tests include Islet Antigen-2 (IA-2) Autoantibody (3001499), Glutamic Acid Decarboxylase Antibody (2001771), Islet Cell Cytoplasmic Antibody, IgG (0050138), and Zinc Transporter 8 Antibody (2006196). Do not use to differentiate type 1 DM from type 2 DM, for most cases.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube or plain red.

Specimen Preparation

Transfer 0.5 mL serum to an ARUP Standard Transport Tube. (Min: 0.1 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

Plasma. Hemolyzed or lipemic specimens.

Remarks
Stability

After separation from cells: Ambient: 24 hours; Refrigerated: 1 week; Frozen: 2 months

Methodology

Semi-Quantitative Radioimmunoassay

Performed

Tue, Wed, Fri

Reported

2-5 days

Reference Interval

Effective May 21, 2012

0.0-0.4 Kronus Units/mL

Interpretive Data

A value greater than 0.4 Kronus Units/mL is considered positive for Insulin Antibody. Kronus units are arbitrary.
Kronus Units = U/mL. 

This assay is intended for the semi-quantitative determination of antibodies to endogenous insulin or antibodies to exogenous insulin in human serum. Antibodies to exogenous insulin therapies may be detected using this method. The magnitude of the measured result is not related to disease progression. Results should be interpreted within the context of clinical symptoms.

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

86337

Components

Component Test Code* Component Chart Name LOINC
0098223 Insulin Antibody 56546-5
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • anti-insulin antibody
  • Human Insulin Antibodies
  • insulin AB
  • Insulin Antibodies, Serum
Insulin Antibody