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Test ID: Glutamic acid decarboxylase (GAD) antibody
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Glutamic acid decarboxylase (GAD) antibody
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Useful For
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Assessing to diagnosis of type 1 diabetes mellitus (insuline-dependent diabetes mellitus) by measuring of human autoantibodies against glutamic acid decarboxylase (GAD) in serum.
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Method name and description
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Method: Enzyme-Linked Immunosorbent Assay (ELISA).
GAD antigen is bound to the wells of a microwell plate under conditions that will preserve the antigen in its native state. The calibrators, controls and patients sera are added to separate wells, allowing any GAD antibodies present to bind to the immobilized antigen. Bound antibodies are available to act divalently and form a bridge between GAD on microplate well and biotin-labeled GAD, which is added in a second incubation step. To detect the bound biotin, a third incubation is carried out using enzyme-labeled avidin (conjugate), which capable of promoting a color reaction.. The intensity of the color produced is directly proportional to the presence of antibodies against GAD.
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Reporting name
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Glutamic Acid Decarboxylase
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Clinical information
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Autoantibodies against the 65 kDa isoform of glutamate decarboxylase are detectable in up to 90% of all patients at the diagnosis of diabetes mellitus type 1 and can even be detected years prior to the onset of clinical symptoms of the disease. Before breakout of the disease they indicate a high individual risk of diabetes. The detection of anti-GAD autoantibodies enables the early diagnosis of diabetes mellitus type 1, which mostly occurs already in childhood. In adults, the late manifestation of diabetes mellitus type 1(LADA. Latent autoimmune diabetes of adults) can be clearly diagnosed by autoantibody determination.
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Aliases
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Anti-Glutamic Acid Decarboxylase Ab.
Anti-GAD Antibodies
GAD
GAD65 Antibody Assay
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Specimen type / Specimen volume / Specimen container
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Specimen type: Serum sample.
Specimen Volume: At minimum 3 mL whole blood or 0.5 mL serum.
Container Tube: Plan tube /Serum gel (Yellow top tubes).
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Storage and transport instructions
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Separated serum samples can be stored at 2-8°C for up to 14 days.
Separated serum samples should be frozen at below -20°C for any long-term storage.
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Specimen Rejection Criteria
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Quantity not sufficient (QNS)
Hemolysis
Lipemic
Wrong collection container
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Biological reference intervals and clinical decision values
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| Interpretation of Test Results |
Reference Values (IU/mL) |
| Negative |
<10 |
| Positive |
≥10 |
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Turnaround time / Days and times test performed / Specimen retention time
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Turnaround Time: 14 working days.
Days and Times test performed: Once every two weeks from 7:00 to 15:00.
Specimen retention time: Approximately 14 days.
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