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Test ID IA2 Islet Antigen 2 (IA-2) Antibody, Serum

Useful For

Clinical distinction of type 1 from type 2 diabetes mellitus

 

Identification of individuals at risk of type 1 diabetes (including high-risk relatives of patients with diabetes)

 

Prediction of future need for insulin treatment in adult-onset diabetic patients

Method Name

Radioimmunoassay (RIA)

Reporting Name

IA-2 Ab, S

Specimen Type

Serum

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 1 mL

Specimen Minimum Volume

0.75 mL

Specimen Stability Information

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

Clinical Information

Islet cell autoantibodies have been known to be associated with type 1 diabetes mellitus for 36 years. In recent years, several autoantigens against which islet antibodies are directed have been identified. These include the tyrosine phosphatase-related islet antigen 2 (IA-2), glutamic acid decarboxylase 65, the zinc transporter ZnT8, and insulin. One or more of these autoantibodies are detected in 96% of patients with type 1 diabetes, and are detectable before clinical onset, as well as in symptomatic individuals. A serological study of 50 type 1 diabetics and 50 control subjects conducted simultaneously across 43 laboratories in 16 countries demonstrated a median sensitivity of 57% and a median specificity of 99% for IA-2 antibody in type 1 diabetes. Prospective studies in relatives of patients with type 1 diabetes have shown that development of 1 or more islet autoantibodies (including IA-2 antibody) provides an early marker of progression to type 1 diabetes. Autoantibody profiles identifying patients destined to develop type 1 diabetes are usually detectable before age 3. In 1 study of relatives seropositive for IA-2 antibody, the risk of developing type 1 diabetes within 5 years was 65.3%. Some patients with type 1 diabetes are initially diagnosed as having type 2 diabetes because of symptom onset in adulthood, societal obesity, and initial insulin-independence. These patients with "latent autoimmune diabetes in adulthood" may be distinguished from those patients with type 2 diabetes by detection of 1 or more islet autoantibodies (including IA-2).

Reference Values

≤0.02 nmol/L

Reference values apply to all ages.

Cautions

Negative results do not exclude the diagnosis of or future risk for type 1 diabetes mellitus. The risk of developing type 1 diabetes may be stratified further by testing for: 1) antibodies targeting insulin, glutamic acid decarboxylase, and zinc transporter 8 (ZnT8) and 2) HLA genetic markers. Careful monitoring of hyperglycemia is the mainstay of determining the requirement for insulin therapy.

Day(s) Performed

Tuesday, Friday; 10 p.m.

Report Available

3 days/negative, 5 days/positive

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

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

CPT Code Information

86341

NY State Approved

Yes