CLIA Scl-70
Chemiluminescence kit for the detection of Scl-70 antibodies in human serum or plasma.
Runs on
KleeYa® Automated CLIA Analyser
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This kit in detail
- 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
Description
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 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: 3-320 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-Scl050
- Size: 50 tests
- Regulatory status: CE IVD
- Clinical topic: Immunology & Autoimmune Diseases
- Diagnostic panel: Rheumatic Diseases
- Producer: TestLine Clinical Diagnostics s.r.o.
References
- 19393194,20854935,20933614,20175839,20833272,20538173,20146695,22743034,15804705
- 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.
- 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.
- 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.
- 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.
- 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.
- Reagent Cartridge with specific reagents for the assay
- magnetic particles
- calibrators
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Safety information
Product brochure
Declaration of conformity
Frequently paired with this kit
Other assays and instruments lab teams add alongside the CLIA Scl-70.
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