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Immunology · SS-B CLIA
TestLine Distributed by Goffin Diagnostics

CLIA SS-B

Chemiluminescence kit for the detection of SS-B antibodies in human serum or plasma.

CLIA CE-IVD TestLine 1 Package (50 Tests)
Technique
CLIA
Brand
TestLine
Packaging
1 Package (50 Tests)
Diagnostic Panel
Rheumatic Diseases
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Runs on KleeYa® Automated CLIA Analyser See the analyser and everything it runs

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Product details

This kit in detail

  • Detection of anti-SS-B/La antibodies, IgG class
  • Evaluating patients with signs and symptoms of a connective tissue disease and positive test for antinuclear antibodies
  • A positive result for SS-A/Ro60 antibodies indicates connective tissue disease, including Sjögren’s syndrome and systemic lupus erythematodes (SLE)
  • Intended for human serum and plasma
  • Recombinant SS-B/La antigen is used

Description

SS-B/La antigen is a phosphoprotein with molecular weight 48 kDa localized mostly in a complex with various RNA molecules in both the cell nucleus and the cytoplasm.

Autoantibodies against SS-B/La are found alone very rarely. They are more frequently associated with antibodies against SS-A/Ro antigen. Antibodies against SS-B/La are typical mainly for Sjögren’s syndrome (50-60%), particularly in extraglandular manifestations in lung, kidney, and liver. Anti-SS-B/La are positive in 15% of patients with systemic lupus erythematodes (SLE). The antibodies may be present few years before the disease starts. They are detected together with anti-SS-A/Ro antibodies in neonatal lupus.

Antibodies against SS-B/La as well as anti-Ro52 antibodies significantly increase a risk of congenital atrioventricular block (CAVB).

Antigen Used: Recombinant SS-B/La antigen.

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-SSB050
  • 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
  • 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.
  • 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.
  • 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.
  • Provost TT. Anti-Ro(SSA) and anti-La(SSB) antibodies in lupus erythematosus and Sjögren’s syndrome. Keio J Med. 1991 Jun;40(2):72-7. doi: 10.2302/kjm.40.72. PMID: 1881026.
  • Miranda-Carús ME, Askanase AD, Clancy RM, Di Donato F, Chou TM, Libera MR, Chan EK, Buyon JP. Anti-SSA/Ro and anti-SSB/La autoantibodies bind the surface of apoptotic fetal cardiocytes and promote secretion of TNF-alpha by macrophages. J Immunol. 2000 Nov 1;165(9):5345-51. doi: 10.4049/jimmunol.165.9.5345. PMID: 11046070.
  • Wahren M, Tengnér P, Gunnarsson I, Lundberg I, Hedfors E, Ringertz NR, Pettersson I. Ro/SS-A and La/SS-B antibody level variation in patients with Sjögren’s syndrome and systemic lupus erythematosus. J Autoimmun. 1998 Feb;11(1):29-38. doi: 10.1006/jaut.1997.0173. PMID: 9480721.
  • Ben-Chetrit E, Fischel R, Rubinow A. Anti-SSA/Ro and anti-SSB/La antibodies in serum and saliva of patients with Sjogren’s syndrome. Clin Rheumatol. 1993 Dec;12(4):471-4. doi: 10.1007/BF02231773. PMID: 8124907.
  • Reagent Cartridge with specific reagents for the assay
  • magnetic particles
  • calibrators
Documentation

Datasheets and regulatory documentation

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