CLIA U1RNP
Chemiluminescence kit for the detection of U1RNP antibodies to in human serum or plasma.
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KleeYa® Automated CLIA Analyser
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This kit in detail
- Detection of anti-U1-RNP antibodies, IgG class
- Evaluating patients with signs and symptoms of a connective tissue disease and positive test for antinuclear antibodies
- Aid to evaluate patients with signs and symptoms of systemic lupus erythematosus (SLE)
- Intended for human serum and plasma
- A mixture of recombinant RNP A, RNP C and RNP 68 antigens is used
Description
The U1-snRNP ribonucleoprotein complex, also known as Sm/RNP complex, belongs to a group of small nuclear ribonucleoproteins. In addition to other proteins and RNAs, the snRNP complex includes three proteins (RNP 68, RNP A and RNP C) specific for a certain type of ribonucleoproteins. The sera that contain RNP antibodies react predominately with the RNP A and RNP 68 kD autoantigens. Antibodies to RNP A and RNP C proteins are cross-reactive with SmB and SmB’ antigens.
Antibodies to U1-RNP occur in approximately 40-50% of patients with systemic lupus erythematosus (SLE). They have lower specificity than anti-Sm antibodies. High titres are highly specific in patients with other connective tissue diseases, particularly mixed connective tissue disease (MCTD, Sharp’s syndrome). MCTD is characterized by high levels of RNP antibodies without detectable Sm antibodies or double-stranded DNA (dsDNA). MCTD resembles SLE but is not accompanied by kidney damage.
Antigen Used: A mixture of recombinant RNP A, RNP C and RNP 68 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-RNP050
- 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
- Carpintero MF, Martinez L, Fernandez I, Romero AC, Mejia C, Zang YJ, Hoffman RW, Greidinger EL. Diagnosis and risk stratification in patients with anti-RNP autoimmunity. Lupus. 2015 Sep;24(10):1057-66. doi: 10.1177/0961203315575586. Epub 2015 Mar 2. PMID: 25736140; PMCID: PMC4529793.
- Sapkota B, Al Khalili Y. Mixed Connective Tissue Disease. 2021 Jan 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan–. PMID: 31194355.
- Gunnarsson R, Hetlevik SO, Lilleby V, Molberg Ø. Mixed connective tissue disease. Best Pract Res Clin Rheumatol. 2016 Feb;30(1):95-111. doi: 10.1016/j.berh.2016.03.002. Epub 2016 Apr 12. PMID: 27421219.
- 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.
- Dima A, Jurcut C, Baicus C. The impact of anti-U1-RNP positivity: systemic lupus erythematosus versus mixed connective tissue disease. Rheumatol Int. 2018 Jul;38(7):1169-1178. doi: 10.1007/s00296-018-4059-4. Epub 2018 May 23. PMID: 29796907.
- Tektonidou MG, Anapliotou M, Vlachoyiannopoulos P, Moutsopoulos HM. Presence of systemic autoimmune disorders in patients with autoimmune thyroid diseases. Ann Rheum Dis. 2004 Sep;63(9):1159-61. doi: 10.1136/ard.2004.022624. PMID: 15308528; PMCID: PMC1755126.
- 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 U1RNP.
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