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CLIA ENA screen plus

Chemiluminescence kit for the detection of IgG antibodies to extractable nuclear antigens and centromere B in human serum or plasma.

Catalog Number: CL-ENA100
Size: 100 tests
Regulatory status: CE IVD
Clinical topic: Immunology & Autoimmune Diseases
Diagnostic panel: Rheumatic Diseases
CLIA ENA screen plus
  • Detection of IgG antibodies to extractable nuclear antigens and centromere B (ENA)
  • Differential diagnosis of systemic autoimmune diseases
  • Monitoring autoimmune disease progression
  • Intended for human serum and citrate plasma
  • A mixture of native and recombinant antigens is used: Ro52/SS-A, Ro60/SS-A, La/SS-B, RNP-A, RNP-C, RNP 68, Sm, Scl-70, Jo-1, and centromere B

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 specifications

Technical data
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Technical data

Assay time30 min
Assay stability30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
Sample matrix Serum, Plasma
Sample volume10 µL
Sample stability7 days at 2-8 °C, 24 months at -20 °C
Measuring range3 - 320 U/ml
Assay/kit contentReagent Cartridge with specific reagents for the assay, magnetic particles, calibrators
Complementary productsWash buffer, Anchor® Tips, Stackable cuvettes, Trigger solutions

The kits are CE-IVD certified and intended for professional use.


References to CLIA ENA screen plus

  • 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.
    See more on PubMed
  • 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.
    See more on PubMed
  • 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.
    See more on PubMed
  • Sapkota B, Al Khalili Y. Mixed Connective Tissue Disease. 2021 Jan 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan–. PMID: 31194355.
    See more on PubMed
  • 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.
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  • 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.
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