• Use of recombinant human glutamic acid decarboxylase (GAD65)
• Ready-to-use (exception: wash buffer), color- and barcoded reagents
• Quality assured handling in routine laboratories
• Incubation at room temperature
• Quantitative determination of antibodies against GAD65)
• Calibrated with the international standard preparation NIBSC code 97/550
• Results expressed in IU/mL
• Excellent diagnostic sensitivity and specificity
• High precision within the measurement range
• CE marked
• Fully automatable
Intended Purpose
The Medizym® anti-GAD M is a quantitative immunoassay for the determination of antibodies against Glutamic Acid Decarboxylase (GAD65) in human serum. The Medizym® anti-GAD M is intended as an aid in the diagnosis of diabetes mellitus type 1 in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.
Diagnostic Relevance
Diabetes mellitus type 1 is a chronic autoimmune disease in which the insulin-producing beta cells of the islets of Langerhans in the pancreas are destroyed. The consequence of this destruction is a reduced insulin production, which results in high blood sugar levels as diabetes mellitus. Genetic predispositions and viral infections are considered risk factors, but the exact causes have not yet been fully clarified.