Epic Code LAB1232002 Glutamic Acid Decarboxylase (GAD65) Antibody Assay, Serum
Test Name Alias
GAD Antibody, GAD65, stiff-man syndrome | LAB650 | GAD65 | Quest: 34878
Interface Order Alias
1232002
Clinical Information
Glutamic Acid Decarboxylase-65 Antibody - Glutamic acid decarboxylase (GAD-65) antibody is useful to diagnose insulin dependent diabetes mellitus [Type I diabetes (autoimmune-mediated diabetes)] to assess risk for development of Type I diabetes, to predict onset of Type I diabetes, and risk of development of related endocrine disorders, e.g., thyroiditis. Before clinical onset, Type I diabetes is characterized by lymphocytic infiltration of the islet cells, and by circulating autoantibodies against a variety of islet cell antigens, including GAD-65, IA-2 (a tyrosine phosphatase-like protein), and insulin (IAA).
Specimen Requirements
Specimen Collection Criteria
Collect (preferred specimen): One Gold-top SST tube.
Also acceptable: One plain Red-top tube.
Physician Office/Draw Specimen Preparation
Let specimen clot 30-60 minutes then centrifuge to separate serum from cells. Transfer serum to plastic transport tube and maintain at room temperature (20-26°C or 68-78.8°F) prior to transport.
In-Lab Processing
Let specimen clot 30-60 minutes then centrifuge to separate serum from cells. Transfer serum to plastic transport tube and maintain at room temperature (20-26°C or 68-78.8°F) prior to transport.
Specimen Transport Temperature
Transport: 1.0 mL serum, room temperature (20-26°C or 68-78.8°F).. (Minimum: 0.5 mL)
Rejection Criteria
- Grossly hemolyzed specimens.
- Grossly icteric specimens.
- Grossly lipemic specimens.
- Specimens not collected and processed as indicated.
Specimen Stability
Specimen Stability for Testing:
Room Temperature (20-26°C or 68-78.8°F): 7 days
Refrigerated (2-8°C or 36-46°F): 14 days
Frozen (-20°C/-4°F or below): 60 days
Specimen Storage in Department Prior to Disposal:
Specimen retention time is determined by the policy of the reference laboratory. Contact the Send Outs Laboratory with any questions.
Test Frequency
Performed: Sunday – Friday.
Results available in 3-5 days.
Reference Range
<5 IU/mL
Performing Department
Send Outs
Performing Department Laboratory Location
Sent to Quest Diagnostics- Wood Dale, IL
Methodology
Enzyme Linked Immunosorbent Assay (ELISA)
CPT
86341
LOINC
56540-8
Reviewed Date
11/2/2025
Orderable Regions
Send Outs