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, SSpecimen Type
SerumContainer/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/positivePerforming Laboratory

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