Medical Necessity Documentation:
Client Notes:
Patient Preparation:
Specimen Requirements:
1.0 mL Serum from a Red Top Tube in a Plastic Vial
Collection Instructions:
Minimum Volume:
0.5 mL Serum
Transport & Storage: Temperature/Stability:
7 days Ambient (Transport)
14 days Refrigerated
60 days Frozen
Rejection Criteria:
Hemolysis, Lipemia, and reject due to thawing or any other rejections; room temperature
Reference Range:
<5 IU/mL
Critical Ranges:
Test Comments:
Limitations GAD-65 antibodies are detected in 20% of diabetic twins who remain disease-free for long periods of time and in 8% of healthy individuals.
Methodology:
Enzyme Linked Immunosorbent Assay (ELISA)
Clinical Significance:
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).
Documentation:
Custom Panel:
No
PRODUCTION SCHEDULE
Turn Around Time:
3 to 5 days
Days Performed:
Sunday, Monday, Tuesday, Wednesday, Thursday, Friday
Sites Performed:
Quest - Chantilly
PHL Test Code:
GLUT1
EPIC Test Code:
LAB650
Send Out Test Code:
34878
Alternate Test Names:
Anti-GAD; GAD; GAD-65; Glutamic Acid Decarboxylase Autoabs; Glutamic Acid Decarboxylase-65 Ab; Glutamic Acid Decarboxylase-65 Antibody
CPT Coding:
86341