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Test ID: GD65S
Glutamic Acid Decarboxylase (GAD65) Antibody Assay, Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

81596

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

Assessing susceptibility to autoimmune (type 1, insulin-dependent) diabetes mellitus and related endocrine disorders (eg, thyroiditis and pernicious anemia). Titers generally < or =0.02 nmol/L. A second islet cell antibody (IA-2) is more predictive for development of type 1 diabetes, but less frequent than glutamic acid decarboxylase (GAD65) antibody amongst diabetic patients. Insulin autoantibodies also serve as a marker of susceptibility to type 1 diabetes.

 

Distinguishing between patients with type 1 and type 2 diabetes. Assays for IA-2, insulin, gastric parietal cell, thyroglobulin, and thyroid peroxidase antibodies, complement GAD65 antibody in this context; titers generally < or =0.02 nmol/L.

 

Confirming a diagnosis of stiff-man syndrome, autoimmune encephalitis, cerebellitis, brain stem encephalitis, myelitis; titers generally > or =0.03 nmol/L

 

Confirming susceptibility to organ-specific neurological disorders (eg, myasthenia gravis, Lambert-Eaton syndrome); titers generally < or =0.02 nmol/L

Method Name A short description of the method used to perform the test

Radioimmunoassay (RIA)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

GAD65 Ab Assay, S

Aliases Lists additional common names for a test, as an aid in searching

64K Antibody
Anti-GAD Antibodies
Anti-Glutamic Acid Decarboxylase Ab
Beta Cell Antibody
GAD65 Antibody Assay
Pancreatic Islet Cell Ab
Stiffman Syndrome
Glutamate Decarboxylase Antibodies (GAD65)

Specimen Type Describes the specimen type needed for testing

Serum

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Container/Tube: 

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 1 mL

Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

0.75 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross reject

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
SerumRefrigerated (preferred)28 days
 Frozen 28 days
 Ambient 72 hours

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Glutamic acid decarboxylase (GAD) is a neuronal enzyme involved in the synthesis of the neurotransmitter gamma-aminobutyric acid (GABA). Antibodies directed against the 65-kd isoform of GAD (GAD65) are seen in a variety of autoimmune neurologic disorders including stiff-man (Moersch-Woltman) syndrome, autoimmune cerebellitis, brain stem encephalitis, seizure disorders, neuromyelitis optica and other myelopathies, myasthenia gravis, Lambert-Eaton syndrome, and dysautonomia.

 

GAD65 antibody is also the major pancreatic islet antibody and an important serological marker of predisposition to type 1 diabetes. GAD65 autoantibody also serves as a marker of predisposition to other autoimmune disease that occur with type 1 diabetes, including thyroid disease (eg, thyrotoxicosis, Grave disease, Hashimoto thyroiditis, hypothyroidism), pernicious anemia, premature ovarian failure, Addison disease, (idiopathic adrenocortical failure) and vitiligo.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

< or =0.02 nmol/L

Reference values apply to all ages.

Interpretation Provides information to assist in interpretation of the test results

High titers (> or =0.02 nmol/L) are found in classic stiff-man syndrome (93% positive) and in related autoimmune neurologic disorders (eg, acquired cerebellar ataxia, some acquired nonparaneoplastic encephalomyelopathies).

 

Diabetic patients with polyendocrine disorders also generally have glutamic acid decarboxylase (GAD65) antibody values > or =0.02 nmol/L.

 

Values in patients who have type 1 diabetes without a polyendocrine or autoimmune neurologic syndrome are usually < or =0.02 nmol/L. Low titers (0.03-19.9 nmol/L) are detectable in the serum of approximately 80% of type 1 diabetic patients. Conversely, low titers are detectable in the serum of <5% of type 2 diabetic patients.

 

Low titers are found in approximately 25% of patients with myasthenia gravis, Lambert-Eaton syndrome, and rarer autoimmune neurological disorders. Eight percent of healthy Olmsted County residents over age 50 have low-positive values. These are not false positive; the antibodies are inhibited by unlabeled GAD65 antigen and are accompanied in at least 50% of cases by related organ-specific autoantibodies.

 

Values > or =0.03 nmol/L are consistent with susceptibility to autoimmune (type 1) diabetes and related endocrine disorders (thyroiditis and pernicious anemia).

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Antibodies specific for glutamic acid decarboxylase (GAD65) account for most, but not all, antibodies detected in the islet cell antibody test (IA-2). IA-2 (a protein tyrosine kinase-like protein) insulin and zinc transporter-8 antibodies are complementary islet cell antibodies.

 

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 1 week and assayed if sufficiently decayed, or canceled if radioactivity remains.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. 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 December;73(12):1161-1166

2. Kawasaki E, Yu L, Gianani R, et al: Evaluation of islet cell antigen (ICA) 512/IA-2 autoantibody radioassays using overlapping ICA512/IA-2 constructs. J Clin Endocrinol Metab 1997 February;82(2):375-380

3. Saiz A, Arpa J, Sagasta A, et al: Autoantibodies to glutamic acid decarboxylase in three patients with cerebellar ataxia, late-onset insulin-dependent diabetes mellitus and polyendocrine autoimmunity. Neurology 1997 October;49(4):1026-1030

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

Method Description Describes how the test is performed and provides a method-specific reference

(125)I-labeled recombinant human glutamic acid decarboxylase (GAD65) is incubated with the patient's diluted serum. Antihuman IgG and IgM are then added to form an immunoprecipitate. After washing the precipitated immune complexes, specific antibodies are detected by counting gamma-emission from the pellet's bound (125)I-GAD65.(Walikonis JE, Lennon VA: Radioimmunassay 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 December;73[12]:1161-1166)

PDF Report Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Sunday through Thursday; 10 p.m.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

2 days/negative 3 days/positive

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

6 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

28 days

Performing Laboratory Location The location of the laboratory that performs the test

Rochester

Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

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

CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

86341

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
81596GAD65 Ab Assay, S30347-9