CLIA ENA screen plus

Description

ENA Screen is a serology test to detect IgG autoantibodies against extractable nuclear antigens (ENAs), which is a subgroup of antinuclear antibodies (ANAs) not reacting with chromatin. ENA screen is usually used following a positive result in an antinuclear antibody (ANA) test.

ENAs are mainly recognized by sera from patients with systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), systemic sclerosis, myositis, Sjögren’s, scleroderma, polymyositis, and rheumatoid arthritis. Classical autoantigens detectable in sera from SLE patients are Smith-Protein (Sm), ribonucleoproteins (RNP), Robert-Antigen/Sjögren’s A (Ro/SSA), and Lane-Antigen/Sjögren’s B (La/SSB); they are usually completed with Scl-70 and Jo-1 antigens. The use of the centromere B antigen is an extension of the standard antigen set.

Technical data

• Assay time: 30 min
• 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
• Sample stability: 7 days at 2-8 °C, 24 months at -20 °C
• 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-ENA100
• Size: 100 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
• Phan TG, Wong RC, Adelstein S. Autoantibodies to extractable nuclear antigens: making detection and interpretation more meaningful. Clin Diagn Lab Immunol. 2002 Jan;9(1):1-7. doi: 10.1128/cdli.9.1.1-7.2002. PMID: 11777822; PMCID: PMC119916.
• Lock RJ, Unsworth DJ. Antibodies to extractable nuclear antigens. Has technological drift affected clinical interpretation? J Clin Pathol. 2001 Mar;54(3):187-90. doi: 10.1136/jcp.54.3.187. PMID: 11253128; PMCID: PMC1731369.
• Selmi C, Ceribelli A, Generali E, Scirè CA, Alborghetti F, Colloredo G, Porrati L, Achenza MI, De Santis M, Cavaciocchi F, Massarotti M, Isailovic N, Paleari V, Invernizzi P, Matthias T, Zucchi A, Meroni PL. Serum antinuclear and extractable nuclear antigen antibody prevalence and associated morbidity and mortality in the general population over 15 years. Autoimmun Rev. 2016 Feb;15(2):162-6. doi: 10.1016/j.autrev.2015.10.007. Epub 2015 Oct 30. PMID: 26524640.
• Sapkota B, Al Khalili Y. Mixed Connective Tissue Disease. 2021 Jan 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan–. PMID: 31194355.
• Deprettere AJ, Van Acker KJ, De Clerck LS, Docx MK, Stevens WJ, Van Bever HP. Diagnosis of Sjögren’s syndrome in children. Am J Dis Child. 1988 Nov;142(11):1185-7. doi: 10.1001/archpedi.1988.02150110063020. PMID: 3052034.
• Lawrence JM 3rd, Moore TL, Osborn TG, Nesher G, Madson KL, Kinsella MB. Autoantibody studies in juvenile rheumatoid arthritis. Semin Arthritis Rheum. 1993 Feb;22(4):265-74. doi: 10.1016/0049-0172(93)80074-p. PMID: 8484133.

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