Mediyzm® anti-GAD

Type 1 diabetes mellitus (T1DM) is a chronic autoimmune disease, caused by the deterioration of insulin-producing pancreatic beta cells. Autoantibodies against glutamate decarboxylase (GAD-AAb) are essential markers for this autoimmune process. These autoantibodies can be detected in 70-80 percent of newly diagnosed T1DM patients. Predominantly children and adolescents are affected by T1DM.

Medizym® anti-GAD offers:

  • Efficient early diagnosis for patients with high risk for T1DM
  • Prognosis for first-degree relatives of T1DM patients
  • Prognosis for the clinical course (insulin obligation) when diagnosed with “diabetes mellitus”
  • Differentiation to late occurring forms of T1DM (LADA) of type 2 Diabetes.

Medizym® anti-GAD is an enzyme immunoassay for the quantitative determination of autoantibodies against GAD65 in human serum. The assay uses the ability of the GAD65 antibodies to form a bridge between immobilized GAD65 and the GAD65 biotin of the liquid phase. The assay is calibrated against a WHO reference standard. Using a cut off of 5 IU/ml the Medizym® anti-GAD has a diagnostic sensitivity of 93.2 percent regarding patients with a recently manifested type 1 diabetes and a diagnostic specificity of 98.6 percent.

Assay principle Enzyme immunoassay, ELISA, bridge assay
Size of assay 96 determinations
Indication Type 1 diabetes mellitus (T1DM)
Parameter Antibody against GAD65
Preparation undiluted patient samples, standards and controls ready to use
Result quantitative: IU/ml   Cut-off: ≥ 5,0 U/ml
Incubation time 60 min RT - 60 min RT - 20 min RT - 20 min RT in the dark
Substrate Tetramethylbenzidine (TMB), 450 nm
Sample material human Serum

Using the Medizym® anti-GAD 96 determinations can be evaluated within 160 minutes. The quantitative analysis results from a photometer for microtiter plates in IU/ml. The kit is designed for manual processing as well as for automated ELISA systems.

Towns, R., Pietropaolo, M. GAD65 autoantibodies and its role as biomarker of Type 1 diabetes and Latent Autoimmune Diabetes in Adults (LADA). Drugs Future 2011; 36(11):847.

Winter, W.E., Harris, N., Schatz, D. Immunological markers in the diagnosis and prediction of autoimmune Type 1a diabetes. Clinical Diabetes 2002; (20): 183-191.