CLIA Sm

Description

Sm is a small nuclear ribonucleoprotein composed of several protein autoantigens designated B, B1, D, E, F, and G, which range in size from 11 kD to 26 kD. Sm is a part of the U1-snRNP ribonucleoprotein complex, also known as Sm/RNP complex. Sm (Smith) antigen, the ribonucleoprotein nucleus is common to all snRNPs. Antibodies to Sm antigen and U1-snRNP specific proteins (RNP 68, RNP A, RNP C) are often found together.

Anti-Sm antibodies are highly specific for systemic lupus erythematosus (SLE). They are found in 20–30% of patients with SLE and represent an important tool in SLE serological diagnostics. Anti-Sm antibody levels remain relatively constant over time in patients with SLE and occur usually in patients who also have U1-snRNP antibodies.

Antigen Used: Native Sm 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-Sm0050
• 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
• Egner W. The use of laboratory tests in the diagnosis of SLE. J Clin Pathol. 2000 Jun;53(6):424-32. doi: 10.1136/jcp.53.6.424. PMID: 10911799; PMCID: PMC1731203.
• Ching KH, Burbelo PD, Tipton C, Wei C, Petri M, Sanz I, Iadarola MJ. Two major autoantibody clusters in systemic lupus erythematosus. PLoS One. 2012;7(2):e32001. doi: 10.1371/journal.pone.0032001. Epub 2012 Feb 21. PMID: 22363785; PMCID: PMC3283706.
• Cozzani E, Drosera M, Gasparini G, Parodi A. Serology of Lupus Erythematosus: Correlation between Immunopathological Features and Clinical Aspects. Autoimmune Dis. 2014;2014:321359. doi: 10.1155/2014/321359. Epub 2014 Feb 6. PMID: 24649358; PMCID: PMC3932647.
• Yu C, Gershwin ME, Chang C. Diagnostic criteria for systemic lupus erythematosus: a critical review. J Autoimmun. 2014 Feb-Mar;48-49:10-3. doi: 10.1016/j.jaut.2014.01.004. Epub 2014 Jan 21. PMID: 24461385.
• Flechsig A, Rose T, Barkhudarova F, Strauss R, Klotsche J, Dähnrich C, Schlumberger W, Enghard P, Burmester GR, Hiepe F, Biesen R. What is the clinical significance of anti-Sm antibodies in systemic lupus erythematosus? A comparison with anti-dsDNA antibodies and C3. Clin Exp Rheumatol. 2017 Jul- Aug;35(4):598-606. Epub 2017 Mar 3. PMID: 28281463.
• Combe B, Rucheton M, Graafland H, Lussiez V, Brunel C, Sany J. Clinical significance of anti-RNP and anti-Sm autoantibodies as determined by immunoblotting and immunoprecipitation in sera from patients with connective tissue diseases. Clin Exp Immunol. 1989 Jan;75(1):18-24. PMID: 2702772; PMCID: PMC1541873.
• Hoffman IE, Peene I, Meheus L, Huizinga TW, Cebecauer L, Isenberg D, De Bosschere K, Hulstaert F, Veys EM, De Keyser F. Specific antinuclear antibodies are associated with clinical features in systemic lupus erythematosus. Ann Rheum Dis. 2004 Sep;63(9):1155-8. doi: 10.1136/ard.2003.013417. PMID: 15308527; PMCID: PMC1755119.

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