3506 – Medizym^® anti-IA2 M

Highlights

• Use of recombinant human protein tyrosine phosphatase (IA2)
• 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 IA2
• 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 Use

The Medizym^® anti-IA2 M is a quantitative enzyme-linked immunosorbent assay for the determination of antibodies against Protein Tyrosine Phosphatase (IA2) in human serum. The Medizym^® anti-IA2 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 represents a chronic autoimmune disease in which the immune system actively destroys the insulin-producing beta cells in the islets of Langerhans of the pancreas. As a result, insulin production decreases significantly, causing persistently elevated blood glucose levels. Although genetic predisposition and viral infections contribute to disease risk, the precise triggers of disease onset remain incompletely understood.

Role of Autoantibodies

The immune-mediated destruction of pancreatic beta cells involves islet cell antibodies (ICA). These antibodies target multiple pancreatic antigens, including glutamic acid decarboxylase (GAD65), protein tyrosine phosphatase IA2, zinc transporter 8 (ZnT8), and insulin. Clinicians detect ICAs in approximately 70–80% of patients with diabetes mellitus type 1. These autoantibodies often appear months to years before hyperglycemia develops, making them valuable prognostic markers for identifying individuals at increased risk. Consequently, combined testing for antibodies against GAD65, IA2, ZnT8, and insulin plays a crucial role in diagnosing the disease at onset.

Protein tyrosine phosphatase IA2 resides in the secretory granules of pancreatic beta cells. Antibodies against IA2 appear in most patients with type 1 diabetes and in many individuals during the prediabetic phase. The presence of IA2 autoantibodies correlates strongly with rapid disease progression, providing clinically relevant information for early diagnosis and risk assessment.