3506 – Medizym® anti-IA2 M


• 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 immunoassay 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 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.

The destruction of the insulin-producing beta cells of the pancreas is based on the presence of islet cell antibodies (ICA), which are directed against different antigens of the pancreatic islet cells, such as glutamic acid decarboxylase (GAD65), tyrosine phosphatase (insulinoma-associated antigen 2, IA2), the zinc transporter 8 (ZnT8) and against insulin. Islet cell antibodies (ICA) can be detected in 70 – 80 % of patients with diabetes mellitus. The different antibodies usually appear months to years before the occurrence of elevated blood sugar levels and are therefore also considered important prognostic markers to identify patients with an increased risk of developing diabetes mellitus type 1. The combined detection of antibodies against GAD65, IA2, ZnT8 and insulin is considered an important method for diagnosing diabetes mellitus type 1 at the onset of the disease.

Protein tyrosine phosphatase (insulinoma-associated antigen 2, IA2) is localized in the granules of pancreatic beta cells. Antibodies against IA2 can be detected in the majority of patients with diabetes mellitus type 1 and in a large number of individuals in the prediabetic phase. The appearance of antibodies against the protein tyrosine phosphatase IA2 is correlated with rapid progression of diabetes mellitus type 1.

Product Specifications

Title Medizym® anti-IA2 M
Product code 3506
Indication Diabetes mellitus Type 1
Description Enzyme immunoassay for the quantitative determination of antibodies against Protein Tyrosine Phosphatase (IA2) in human serum
Format Microtiter plate coated with human recombinant Protein Tyrosine Phosphatase (IA2)
Total incubation time 160 min.
Sample volume 50 µL serum
No. of determinations 96 (90 x 1) + 5 x Calibrators and 1 x Control

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.