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CLIA Scl-70

Chemiluminescence kit for the detection of Scl-70 antibodies in human serum or plasma.

Catalog Number: CL-Scl050
Size: 50 tests
Regulatory status: CE IVD
Clinical topic: Immunology & Autoimmune Diseases
Diagnostic panel: Rheumatic Diseases
CLIA Scl-70
  • Detection of anti-Scl-70 antibodies, IgG class
  • Evaluating patients with clinical signs and symptoms compatible with systemic sclerosis and positive test for antinuclear antibodies
  • Intended for human serum and plasma
  • A mixture of native and recombinant Scl-70antigens used

The Scl-70 antigen is a type I DNA topoisomerase. It has a native molecular weight of 100 kDa. The enzyme is degraded to a protein of 70 kDa and less. Anti-Scl-70 antibodies bind to a native form of the antigen as well as to proteolysis products with lower molecular weights.

Presence of Anti-Scl-70 antibodies is highly specific serological marker for diffuse form of systemic scleroderma. They are present in 20-40% of individuals with systemic scleroderma. They indicate worse disease prognosis, and higher probability of musculoskeletal system and organ affections (lung fibrosis, proteinuria, heart damage). Anti-Scl-70 antibodies are rarely present in localized form of scleroderma. The antibody level corresponds with the disease activity.

Antigen Used: A mixture of native and recombinant Scl-70 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 range3-320 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 Scl-70

  • Guldner HH, Szostecki C, Vosberg HP, Lakomek HJ, Penner E, Bautz FA. Scl 70 autoantibodies from scleroderma patients recognize a 95 kDa protein identified as DNA topoisomerase I. Chromosoma. 1986;94(2):132-8. doi: 10.1007/BF00286991. PMID: 2428564.
    See more on PubMed
  • Spencer-Green G, Alter D, Welch HG. Test performance in systemic sclerosis: anti-centromere and anti-Scl-70 antibodies. Am J Med. 1997 Sep;103(3):242-8. doi: 10.1016/s0002-9343(97)00023-5. PMID: 9316557.
    See more on PubMed
  • Ho KT, Reveille JD. The clinical relevance of autoantibodies in scleroderma. Arthritis Res Ther. 2003;5(2):80-93. doi: 10.1186/ar628. Epub 2003 Feb 12. PMID: 12718748; PMCID: PMC165038.
    See more on PubMed
  • Mecoli CA, Casciola-Rosen L. An update on autoantibodies in scleroderma. Curr Opin Rheumatol. 2018 Nov;30(6):548-553. doi: 10.1097/BOR.0000000000000550. PMID: 30148799; PMCID: PMC6546089.
    See more on PubMed
  • Cepeda EJ, Reveille JD. Autoantibodies in systemic sclerosis and fibrosing syndromes: clinical indications and relevance. Curr Opin Rheumatol. 2004 Nov;16(6):723-32. doi: 10.1097/01.bor.0000144760.37777.fa. PMID: 15577611.
    See more on PubMed


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