CLIA SS-A

Description

SS-A/Ro antigen is a ribonucleoprotein (RNP) complex localized in nucleus and cytoplasm. It consists of hYRNA (small cytoplasmic RNA) and two protein antigens of 52 kDa and 60 kDa (Ro52 and Ro60).

Autoantibodies against Ro60 a Ro52 are often found together; anti-SS-B/La antibodies may also occure. Presence of the SS-A/Ro autoantibodies is typical for Sjögren’s syndrome (50 – 70%) and systemic lupus erythematodes (40 – 50%), especially for certain clinical subunits (subacute cutaneous lupus, neonatal lupus), and rheumatoid arthritis. Anti-SS-A/Ro antibodies can be detected approximately 3 years before the SLE diagnosis is reached. SS-A/Ro antibodies are also associated with features of extraglandular inflammation in SLE patients including vasculitis, purpura, cytopenias, and adenopathy.

While anti-Ro60 antibodies are primarily specific for systemic lupus erythematodes and Sjögren’s syndrome, anti-Ro52 antibodies was proved to be individually present (without anti-Ro60) in systemic scleroderma (20%) and myositis (35%), especially in anti-Jo-1 positive patients. Anti-Ro52 as well as anti-SS-B/La antibodies significantly raise the risk of congenital atrioventricular block (CAVB) development. They may be also present in autoimmune liver disease.

Antigen Used: Highly purified native antigen SS-A/Ro60 (60 kDa) and recombinant antigen SS-A/Ro52 (52 kDa).

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-SSA050
• 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
• Didier K, Bolko L, Giusti D, Toquet S, Robbins A, Antonicelli F, Servettaz A. Autoantibodies Associated With Connective Tissue Diseases: What Meaning for Clinicians? Front Immunol. 2018 Mar 26;9:541. doi: 10.3389/fimmu.2018.00541. PMID: 29632529; PMCID: PMC5879136.
• Yoshimi R, Ueda A, Ozato K, Ishigatsubo Y. Clinical and pathological roles of Ro/SSA autoantibody system. Clin Dev Immunol. 2012;2012:606195. doi: 10.1155/2012/606195. Epub 2012 Dec 6. PMID: 23304190; PMCID: PMC3523155.
• Simmons-O’Brien E, Chen S, Watson R, Antoni C, Petri M, Hochberg M, Stevens MB, Provost TT. One hundred anti-Ro (SS-A) antibody positive patients: a 10-year follow-up. Medicine (Baltimore). 1995 May;74(3):109-30. doi: 10.1097/00005792-199505000-00001. PMID: 7760718.
• Provost TT, Talal N, Harley JB, Reichlin M, Alexander E. The relationship between anti-Ro (SS-A) antibody-positive Sjögren’s syndrome and anti-Ro (SS-A) antibody-positive lupus erythematosus. Arch Dermatol. 1988 Jan;124(1):63-71. PMID: 3257371.
• Peene I, Meheus L, Veys EM, De Keyser F. Diagnostic associations in a large and consecutively identified population positive for anti-SSA and/or anti-SSB: the range of associated diseases differs according to the detailed serotype. Ann Rheum Dis. 2002 Dec;61(12):1090-4. doi: 10.1136/ard.61.12.1090. PMID: 12429541; PMCID: PMC1753972.
• Schulte-Pelkum J, Fritzler M, Mahler M. Latest update on the Ro/SS-A autoantibody system. Autoimmun Rev. 2009 Jun;8(7):632-7. doi: 10.1016/j.autrev.2009.02.010. Epub 2009 Feb 12. PMID: 19393201.
• Zampeli E, Mavrommati M, Moutsopoulos HM, Skopouli FN. Anti-Ro52 and/or anti- Ro60 immune reactivity: autoantibody and disease associations. Clin Exp Rheumatol. 2020 Jul-Aug;38 Suppl 126(4):134-141. Epub 2020 Feb 18. PMID: 32083547.
• Theander E, Jonsson R, Sjöström B, Brokstad K, Olsson P, Henriksson G. Prediction of Sjögren’s Syndrome Years Before Diagnosis and Identification of Patients With Early Onset and Severe Disease Course by Autoantibody Profiling. Arthritis Rheumatol. 2015 Sep;67(9):2427-36. doi: 10.1002/art.39214. PMID: 26109563.
• Motta M, Rodriguez-Perez C, Tincani A, Lojacono A, Chirico G. Outcome of infants from mothers with anti-SSA/Ro antibodies. J Perinatol. 2007 May;27(5):278-83. doi: 10.1038/sj.jp.7211688. Epub 2007 Mar 15. PMID: 17363909.
• Costedoat-Chalumeau N, Amoura Z, Villain E, Cohen L, Piette JC. Anti-SSA/Ro antibodies and the heart: more than complete congenital heart block? A review of electrocardiographic and myocardial abnormalities and of treatment options. Arthritis Res Ther. 2005;7(2):69-73. doi: 10.1186/ar1690. Epub 2005 Jan 25. PMID: 15743492; PMCID: PMC1065339.

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