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Glutamic Acid Decarboxylase-65 Antibody

Test Summary

Glutamic Acid Decarboxylase (GAD65) 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).

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

1 mL serum

Minimum Volume

0.5 mL

Instructions

N/A

Patient Preparation

N/A

Storage

Plastic screw-cap vial

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 7 days
  • Refrigerated: 14 days
  • Frozen: 60 days

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.

Other Acceptable Specimens

N/A

Unacceptable Specimens

N/A

Order Code

GLUTAM

EPIC (Premier) Code

LAB586

Includes

N/A

CPT Code

  • 86341

Billing Code

  • 700000

CPT Statement

Methodology

Enzyme Linked Immunosorbent Assay (ELISA)

FDA Status

FDA Approved

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153

Reference Range

<5 IU/mL

Setup Schedule / Expected Turnaround Time

Sunday - Friday evening; Report available: 3 - 5 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

1 mL serum

Minimum Volume

0.5 mL

Instructions

N/A

Patient Preparation

N/A

Storage

Plastic screw-cap vial

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 7 days
  • Refrigerated: 14 days
  • Frozen: 60 days

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.

Other Acceptable Specimens

N/A

Unacceptable Specimens

N/A

Billing

CPT Code

  • 86341

Billing Code

  • 700000

CPT Statement

Result Information

Methodology

Enzyme Linked Immunosorbent Assay (ELISA)

Testing Laboratory

N/A

Reference Range

<5 IU/mL

Setup Schedule / Expected Turnaround Time

Sunday - Friday evening; Report available: 3 - 5 days