The chemiluminescence assay is intended for use as an aid in the diagnosis of diabetes mellitus type I. using IgG antibodies to GAD65 in human serum or plasma in the general population. The quantitative automated assay is designed for professional use in a laboratory.
| Catalog Number: | CL-IA100 |
|---|---|
| Size: | 100 tests |
| Regulatory status: | CE IVD |
| Clinical topic: | Diabetes & Metabolism Disorders |
| Diagnostic panel: | Diabetes |
| Producer: | TestLine Clinical Diagnostics s.r.o. |
IA-2 is an autoantibody marker associated with autoimmune damage to the pancreatic beta cells. It is frequently present in patients with newly diagnosed type 1 diabetes and typically reflects a more active autoimmune process with faster disease progression.
Testing for IA-2 naturally complements GAD65 and increases the overall sensitivity of autoimmune diabetes diagnostics, particularly in patients with unclear classification. While GAD65 is typically found in adult patients with a slower disease course, such as LADA, IA-2 more commonly appears in cases where diabetes progresses more rapidly.
The combination of both markers therefore provides a more comprehensive diagnostic picture and enables the identification of patients with autoimmune diabetes before the disease has fully developed.
The portfolio of markers for functional pancreatic assessment, C-peptide and Insulin, complemented by autoimmune diabetes markers GAD65 and IA-2, which are not commonly available on other CLIA platforms, represents a significant advantage of the CLIA solution from BioVendor Group.
Benefits of BioVendor Group's Diabetes Panel on the CLIA Platform
Benefits of Automated CLIA Tests for GAD65 and IA-2
The CLIA method offers a number of practical advantages over the established ELISA and RIA methods for routine laboratory operations:
| Assay time | 30 min |
| Assay stability | 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C |
| Sample matrix | Serum, Plasma |
| Sample volume | 30 µL |
| Measuring range | 0–500 U/ml |
| Assay/kit content | Reagent Cartridge with specific reagents for the assay, magnetic beads, calibrators |
| Complementary products | Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer |
| Note | The kits are CE-IVD certified and intended for professional use. |
