CLIA SS-A/Ro60

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: 0,5-180 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-Ro6050
• 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
• 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.
• Menéndez A, Gómez J, Escanlar E, Caminal-Montero L, Mozo L. Clinical associations of anti-SSA/Ro60 and anti-Ro52/TRIM21 antibodies: Diagnostic utility of their separate detection. Autoimmunity. 2013 Feb;46(1):32-9. doi: 10.3109/08916934.2012.732131. Epub 2012 Nov 12. PMID: 23039326.
• Robbins A, Hentzien M, Toquet S, Didier K, Servettaz A, Pham BN, Giusti D. Diagnostic Utility of Separate Anti-Ro60 and Anti-Ro52/TRIM21 Antibody Detection in Autoimmune Diseases. Front Immunol. 2019 Mar 12;10:444. doi: 10.3389/fimmu.2019.00444. PMID: 30915082; PMCID: PMC6423153.

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