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-GAD100 |
|---|---|
| Size: | 100 tests |
| Regulatory status: | CE IVD |
| Clinical topic: | Diabetes & Metabolism Disorders |
| Diagnostic panel: | Diabetes |
| Producer: | TestLine Clinical Diagnostics s.r.o. |
GAD65 (glutamate decarboxylase 65) is one of the most significant autoantibodies associated with autoimmune diabetes. The number 65 refers to the molecular weight of the protein, which is 65 kilodaltons. It is frequently found in patients with type 1 diabetes and latent autoimmune diabetes in adults (LADA).
The presence of GAD65 antibodies supports the identification of autoimmune damage to the pancreatic beta cells and helps distinguish autoimmune diabetes from type 2 diabetes, particularly in patients with an atypical clinical presentation.
GAD65 is considered one of the most sensitive markers of autoimmune diabetes, especially in adult patients and in LADA. Its presence can be detected in the early stages of the disease, contributing to earlier diagnosis and appropriate therapeutic decision-making.
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 | 50 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 | 60 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. |
