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Test Code SOFT: Z1000 Glutamic Acid Decarboxylase (GAD65) Antibody Assay, Spinal Fluid

Additional Codes

 

Ordering Mnemonic Mayo Test ID
EPIC NAME: MISCELLANEOUS LAB TEST GD65C
EPIC CODE: LAB000  

 

Reporting Name

GAD65 Ab Assay, CSF

Useful For

Possible use in evaluating patients with autoimmune encephalitis, stiff-person syndrome, autoimmune ataxia, autoimmune epilepsy, and other acquired central nervous system disorders affecting gabaminergic neurotransmission

Method Name

Radioimmunoassay (RIA)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

CSF


Ordering Guidance


This test should not be requested in patients who have recently received radioisotopes, therapeutically or diagnostically, because of potential assay interference. The specific waiting period before specimen collection will depend on the isotope administered, the dose given, and the clearance rate in the individual patient. Specimens will be screened for radioactivity prior to analysis. Radioactive specimens received in the laboratory will be held one week and assayed if sufficiently decayed or canceled if radioactivity remains.



Specimen Required


Container/Tube: Sterile vial

Specimen Volume: 1.5 mL

Collection Instructions: Submit specimen from collection vial 2.


Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
CSF Refrigerated (preferred) 28 days
  Frozen  28 days
  Ambient  72 hours

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Reference Values

≤0.02 nmol/L

Reference values apply to all ages.

Day(s) Performed

Monday through Sunday

CPT Code Information

86341

LOINC Code Information

Test ID Test Order Name Order LOINC Value
GD65C GAD65 Ab Assay, CSF 94359-7

 

Result ID Test Result Name Result LOINC Value
21702 GAD65 Ab Assay, CSF 94359-7

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

Clinical Information

Glutamic acid decarboxylase (GAD) is a neuronal enzyme involved in the synthesis of the neurotransmitter gamma-aminobutyric acid (GABA). Serum antibodies directed against the 65-kDa isoform of GAD (GAD65) are detected in heightened frequency in a variety of autoimmune neurologic disorders, including autoimmune encephalitis, stiff-person (Moersch-Woltman) syndrome, autoimmune ataxia, and autoimmune epilepsy.

Interpretation

Intrathecal synthesis of glutamic acid decarboxylase 65 (GAD65) antibody has been demonstrated in patients with stiff-man syndrome, but cerebrospinal fluid (CSF) values are log orders lower than serum. We have not determined the frequency of GAD65 antibodies in CSF of patients with various diagnoses.

Cautions

Clinical utility of this test remains to be determined.

Clinical Reference

1. McKeon A, Tracy JA. GAD65 neurological autoimmunity. Muscle Nerve. 2017;56(1):15-27. doi:10.1002/mus.25565

2. Pittock SJ, Yoshikawa H, Ahlskog JE, et al. Glutamic acid decarboxylase autoimmunity with brainstem, extrapyramidal and spinal cord dysfunction. Mayo Clin Proc. 2006;81(9):1207-1214

3. McKeon A, Robinson MT, McEvoy KM, et al. Stiff-man syndrome and variants: clinical course, treatments, and outcomes. Arch Neurol. 2012;69(2):230-238

4. Steriade C, Britton J, Dale RC, et al. Acute symptomatic seizures secondary to autoimmune encephalitis and autoimmune-associated epilepsy: Conceptual definitions. Epilepsia. 2020;61(7):1341-1351

5. Bingley PJ. Clinical applications of diabetes antibody testing. J Clin Endocrinol Metab. 2010;95(1):25-33

Method Description

(125)I-labeled recombinant human glutamic acid decarboxylase 65 (GAD65) is incubated with the patient sample. Anti-human IgG is then added to form an immunoprecipitate. After washing the immunoprecipitate, the amount of (125)I-labeled antigen in the immunoprecipitate is measured using a gamma-counter. The amount of gamma emission in the precipitate is proportional to the amount of GAD65-IgG in the sample. Results are reported as units of precipitated antigen (nMol) per L of patient sample.(Walikonis JE, Lennon VA. Radioimmunoassay for glutamic acid decarboxylase [GAD65] autoantibodies as a diagnostic aid for stiff-man syndrome and a correlate of susceptibility to type 1 diabetes mellitus. Mayo Clin Proc. 1998;73[12]:1161-1166; Horta ES, Lennon VA, Lachance DH, et al. Neural autoantibody clusters aid diagnosis of cancer. Clin Cancer Res. 2014;20[14]:3862-9386)

Report Available

3 to 6 days

Specimen Retention Time

28 days

Forms

If not ordering electronically, complete, print, and send a Neurology Specialty Testing Client Test Request (T732) with the specimen.

Secondary ID

84221