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 located in the islets of Langerhans of the pancreas. As a result, insulin production decreases significantly, which consequently leads to persistently elevated blood glucose levels. Although genetic predisposition and viral infections contribute to disease risk, the precise mechanisms that trigger disease onset remain incompletely understood.

Importantly, the immune-mediated destruction of pancreatic beta cells involves the presence of 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. Notably, clinicians detect ICAs in approximately 70–80% of patients with diabetes mellitus type 1. Moreover, these autoantibodies typically appear months to years before hyperglycemia develops. Therefore, clinicians also regard them as valuable prognostic markers for identifying individuals at increased risk of developing type 1 diabetes. 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 localizes within the secretory granules of pancreatic beta cells. Accordingly, clinicians detect antibodies against IA2 in most patients with diabetes mellitus type 1 and in many individuals during the prediabetic phase. Furthermore, the appearance of IA2 autoantibodies correlates strongly with rapid disease progression. Thus, the antibody determination provides clinically relevant information for both early diagnosis and risk assessment.

Publications

• Buianova et al., (2024) Trio-based exome sequencing and high-resolution HLA typing in families of patients with autoimmune adrenal insufficiency and autoimmune polyglandular syndrome
• Savvateeva et al., (2021) Multiplex Autoantibody Detection in Patients with Autoimmune Polyglandular Syndromes