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CLIA Centromere

Chemiluminescence kit for the detection of Centromere antibodies in human serum or plasma.

Catalog Number: CL-CEN050
Size: 50 tests
Regulatory status: CE IVD
Clinical topic: Immunology & Autoimmune Diseases
Diagnostic panel: Rheumatic Diseases
CLIA Centromere
  • Detection of anti-centromere antibodies (ACA), IgG class
  • Diagnosis of systemic sclerosis, highly specific for CREST syndrome
  • Evaluating patients with clinical signs and symptoms compatible with systemic sclerosis
  • Prediction of CREST syndrome
  • Prognostically significant in patients with Raynaud’s phenomenon
  • Intended for human serum and plasma
  • A mixture of recombinant CENP B and CENP A antigens used

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 specifications

Technical data
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Technical data

Assay stability30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
Sample matrix Serum, Plasma
Sample volume10 µL
Measuring range0,5-320 U/ml
Assay/kit contentReagent Cartridge with specific reagents for the assay, magnetic particles, calibrators
Complementary productsWash buffer, Anchor® Tips, Stackable cuvettes, Trigger solutions

The kits are CE-IVD certified and intended for professional use.


References to CLIA Centromere

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  • Kajio N, Takeshita M, Suzuki K, Kaneda Y, Yamane H, Ikeura K, Sato H, Kato S, Shimizu H, Tsunoda K, Takeuchi T. Anti-centromere antibodies target centromere- kinetochore macrocomplex: a comprehensive autoantigen profiling. Ann Rheum Dis. 2020 Nov 18;80(5):651–9. doi: 10.1136/annrheumdis-2020-218881. Epub ahead of print. PMID: 33208344; PMCID: PMC8053351.
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  • Kallenberg CG. Anti-centromere antibodies (ACA). Clin Rheumatol. 1990 Mar;9(1 Suppl 1):136-9. doi: 10.1007/BF02205562. PMID: 2203592.
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  • Kuramoto N, Ohmura K, Ikari K, Yano K, Furu M, Yamakawa N, Hashimoto M, Ito H, Fujii T, Murakami K, Nakashima R, Imura Y, Yukawa N, Yoshifuji H, Taniguchi A, Momohara S, Yamanaka H, Matsuda F, Mimori T, Terao C. Anti-centromere antibody exhibits specific distribution levels among anti-nuclear antibodies and may characterize a distinct subset in rheumatoid arthritis. Sci Rep. 2017 Jul 31;7(1):6911. doi: 10.1038/s41598-017-07137-4. PMID: 28761166; PMCID: PMC5537247.
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