Key Features and Values

– High sensitivity assays provide accurate measurements leading to improved performance in clinical use
– Same sample type can be used across all assays to simplify inclusion into routine serology work-up and provide a cost effective solution
– Long shelf life cost-effective solution by reducing wastage due to expired kits
– Suitable for inclusion on automated plate systems simplifies scale-up of test volume
– Supported by a panel of assays for supporting early detection and differential diagnosis of diabetes type I and II

Product Description

Anti GAD kit is an in vitro quantitative ELISA test for the determination of autoantibodies to glutamic acid decarboxylase (GAD65 Abs) in human serum of prediabetic high risk individuals as well as  insulin-dependent diabetes mellitus patients.  Anti GAD kit is intended for laboratory use only.

Scientific Description
Type 1 diabetes, also known as insulin-dependent diabetes mellitus (IDDM), results from a chronic autoimmune destruction of the insulin-secreting pancreatic beta cells, probably initiated by exposure of genetically susceptible host to environmental agents.  Autoimmune destruction of beta cells is thought to be completely asymptomatic until 80-90% of the cells are lost.  This process may take years to complete and may occur at any time in all ages.  During the preclinical phase, this autoimmune process is marked by circulating autoantibodies to beta cell antigens.  These autoantibodies, such as anti-insulin (IAA), anti-glutamic acid decarboxylase (GAD) and anti-tyrosine phosphatase ICA 512 (IA2), are present years before the onset of type 1 diabetes and prior to clinical symptoms.
GAD, the enzyme that catalyses the conversion of glutamate to GABA, has been identified in two isoforms, with molecular weight of 65.000 (GAD65) and 67.000 (GAD67).  Although GAD autoantibodies are found in type 1 diabetes and in the rare neurological disorder Stiff-man syndrome (SMS), the GAD autoantibodies profile in the two diseases differs.  Autoantibodies of SMS patients recognise a combination of linear and conformational epitopes of GAD while GAD65 autoantibodies in patients with type 1 diabetes are predominantly directed to the conformational epitopes.  GAD65 autoantibodies (GAD65 Abs) are present in 70-80% of newly diagnosed patients with type 1 diabetes.
The combination of the autoantibodies to GAD65 and IA2 is highly relevant for risk assessment of type 1 diabetes in children and adolescence. These tests in combination are more sensitive and predictive than ICA in risk groups, e.g. relatives of patients with type 1 diabetes.  GAD65 Abs also occur in a subset of adults with type 2 diabetes.  These patients can have pronounced hyperglycemia and after therapy with oral hypoglycemic agents for several months to years they may become insulin dependent.  Therefore, these patients are thought to have a slowly progressive form of type 1 diabetes, often called latent diabetes or latent autoimmune diabetes in adults (LADA).  The presence of GAD65 Abs in sera of such patients is a sensitive and specific marker for future insulin dependency.
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Code: DKO082
Clinical Area:
Incubation: 60+60+20+20 min
Sensitivity: 88.6% (cut off 5 IU/mL)
Specificity: 92.3% (cut off 5 IU/mL)
Classification: IVD, CE
Number of Tests: 96
Sample Type: Serum, heparin plasma, EDTA plasma
Sample Volume: 25 μL
Assay Range: N/A