GAD65 Antibody (Sendout)

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General Information

Lab Name
Lab Code
1201
Epic Name

Order using Lab Undefined [LABUND]
External Test Id
2001771
Description

Useful For:

  • Assessing susceptibility to autoimmune (type 1, insulin-dependent) diabetes mellitus and related endocrine disorders (eg, thyroiditis and pernicious anemia)
  • Distinguishing between patients with type 1 and type 2 diabetes

Ordering Guidance: Although a high positive result (>250 IU/mL) could be consistent with stiff-person syndrome, such a result by this assay has been shown to be insufficiently specific for this diagnosis¹ and is not recommended. For a comprehensive evaluation of patients with suspected stiff-person syndrome (classical or focal forms, such as stiff-limb or stiff-trunk) and progressive encephalomyelitis with rigidity and myoclonus, consider ordering Stiff-Person Spectrum Disorders Evaluation, Serum (Sendout) [OLTG #1108].

References
  1. McKeon et al. GAD65 Antibody ELISA with Extended Reportable Range: Validation and Guidance for Neurological Practice. Annals of Clinical and Translational Neurology, 2026; 0:1–10. https://doi.org/10.1002/acn3.70378
Synonyms
2001771, 64K Antibody, Anti GAD Ab, Anti-Glutamic Acid Decarboxylase Ab, Ataxia, Beta Cell Antibody, GD65S, Glutamic Acid Decarboxylase Antibody, Islet Cell Antibody, Pancreatic Islet Cell Ab, RGAD65, RGD65
Components

Interpretation

Method

Semi-quantitative Enzyme-Linked Immunosorbent Assay

Reference Range
Ref. Range Notes
Reference Interval: 0.0-5.0 IU/mL

Interpretive Data:

A value greater than 5.0 IU/mL is considered positive for glutamic acid decarboxylase antibody (GAD Ab).

This assay is intended for the semi-quantitative determination of the GAD Ab in human serum. Results should be interpreted within the context of clinical symptoms.

Ordering & Collection

Specimen Type
Blood
Collection

3 mL blood in GOLD SST or RED TOP tube

Handling Instructions

Outside Laboratories:

  • Centrifuge sample and aliquot serum into a separate plastic vial. Freeze serum at -20°C while awaiting shipment. Transport on dry ice.
  • Interface clients will not be able to order this test directly. Clients should submit orders using a paper requisition.

Stability: Frozen (preferred): 3 months; Refrigerated: 1 week; Ambient: 24 hours.

Quantity
Requested: 1 mL serum
Minimum: 0.5 mL serum

Processing

Receiving Instructions

Centrifuge sample and aliquot serum into a separate plastic vial. Freeze serum at -20°C.

Sendouts:

  • Order ARUP Test: 2001771
  • Interfaced: Yes [Interface: 602; Department: ARPZ]

Stability: Frozen (preferred): 3 months; Refrigerated: 1 week; Ambient: 24 hours.

Misc Sendout

Performance

Lab Department
Frequency
Performed: Sunday through Friday. Reported: 1-3 days from sample receipt at ARUP Laboratories.
Available STAT?
No
Performing Location(s)
Sendout ARUP Laboratories, Inc.
800-522-2787

500 Chipeta Way
Salt Lake City, UT 84108

Billing & Coding

Billing Comments

CPT: 86341