CLIA dsDNA

Description

Antibodies to double-stranded DNA (anti-dsDNA) fall in the group of antinuclear antibodies. Anti-dsDNA is included in the Systemic Lupus International Collaborating Clinics classification criteria (SLICC) for SLE and is also outlined in the classification criteria for SLE of the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR). The antibodies are considered highly specific for systemic lupus erythematosus (SLE). Antibodies to dsDNA are present during the active phase of the disease and are associated with lupus nephritis.

Testing for IgG antibodies to dsDNA is indicated in patients positive for a homogeneous structure of anti-cell antibodies (i.e., Antinuclear Antibodies: ANA) using the HEp-2 substrate by indirect immunofluorescence assay (IFA) along with SLE-compatible clinical features. The serum concentrations of anti-dsDNA may fluctuate with SLE disease activity. An increase in antibody levels may be associated with flares while decline or negative results may indicate response to treatment or disease remission.

Lower titres and low-affinity anti-dsDNA may be present in patients with other systemic diseases / immunopathological conditions (e.g. viral infections), very rarely also in healthy individuals.

Antigen Used: Purified native human dsDNA.

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: 5-500 IU/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-DNA050
• Size: 50 tests
• Regulatory status: CE IVD
• Clinical topic: Immunology & Autoimmune Diseases
• Diagnostic panel: Rheumatic Diseases
• Producer: TestLine Clinical Diagnostics s.r.o.

References

• 26594353,17500073,8427508,31156647,31379858
• Aringer M, Johnson SR. Systemic Lupus Erythematosus Classification and Diagnosis. Rheum Dis Clin North Am. 2021 Aug;47(3):501-511. doi: 10.1016/j.rdc.2021.04.011. Epub 2021 Jun 10. PMID: 34215376.
• Petri M, Orbai AM, Alarcón GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sánchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473. PMID: 22553077; PMCID: PMC3409311.
• Fox BJ, Hockley J, Rigsby P, Dolman C, Meroni PL, Rönnelid J. A WHO Reference Reagent for lupus (anti-dsDNA) antibodies: international collaborative study to evaluate a candidate preparation. Ann Rheum Dis. 2019 Dec;78(12):1677-1680. doi: 10.1136/annrheumdis-2019-215845. Epub 2019 Sep 5. PMID: 31488407; PMCID: PMC6900249.
• Rekvig OP. The dsDNA, Anti-dsDNA Antibody, and Lupus Nephritis: What We Agree on, What Must Be Done, and What the Best Strategy Forward Could Be. Front Immunol. 2019 May 15;10:1104. doi: 10.3389/fimmu.2019.01104. PMID: 31156647; PMCID: PMC6529578.
• Bragazzi NL, Watad A, Damiani G, Adawi M, Amital H, Shoenfeld Y. Role of anti-DNA auto-antibodies as biomarkers of response to treatment in systemic lupus erythematosus patients: hypes and hopes. Insights and implications from a comprehensive review of the literature. Expert Rev Mol Diagn. 2019 Nov;19(11):969-978. doi: 10.1080/14737159.2019.1665511. Epub 2019 Sep 13. PMID: 31516059.
• Lou H, Wojciak-Stothard B, Ruseva MM, Cook HT, Kelleher P, Pickering MC, Mongkolsapaya J, Screaton GR, Xu XN. Autoantibody-dependent amplification of inflammation in SLE. Cell Death Dis. 2020 Sep 9;11(9):729. doi: 10.1038/s41419-020-02928-6. PMID: 32908129; PMCID: PMC7481301.

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