CLIA Centromere

Description

The centromere is the part of a chromosome that links sister chromatids. Centromere proteins may become a target for anti-centromere antibodies (ACA). Most frequently, autoimmune reaction is directed against CENP A (17 kDa), CENP B (80 kDa), or CENP C (140 kDa). The CENP B is considered the most significant autoantigen from the group.

Antibodies to CENP B and CENP A are an important diagnostic marker for systemic sclerosis (scleroderma), found in 20-40% of patients. They are highly specific for the limited form of systemic sclerosis – CREST syndrome (calcinosis, Raynaud’s phenomenon, oesophageal motility abnormalities, sclerodactylia, and telangiectasia). Contrary, they are very rarely found in the diffusion form of the disease. The presence of ACA may predate the clinical diagnosis of CREST syndrome by up to several years. Their presence is prognostically significant in patients with Raynaud’s phenomenon. However, ACA have also been described in some patients with primary biliary cirrhosis and may occur in patients with rheumatoid arthritis or lupus erythematosus.

Antigen Used: Mixture of recombinant CENP B and CENP A antigens.

Technical data

• 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: 10 μL
• Measuring range: 0,5-320 U/ml
• Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
• Note: The kits are CE-IVD certified and intended for professional use.

Specifications

• Catalog Number: CL-CEN050
• Size: 50 tests
• Regulatory status: CE IVD
• Clinical topic: Immunology & Autoimmune Diseases
• Diagnostic panel: Rheumatic Diseases
• Producer: TestLine Clinical Diagnostics s.r.o.

References

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• Reagent Cartridge with specific reagents for the assay
• magnetic particles
• calibrators