TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

Test ID: CRITH    
DNA Double-Stranded (dsDNA) Antibodies by Crithidia luciliae IFA, IgG, Serum

Useful For Suggests clinical disorders or settings where the test may be helpful

Confirmation testing for dsDNA IgG antibodies in patients with clinical features of systemic lupus erythematosus or at-risk for disease

 

This test may not be used independently for monitoring treatment response or establishing remission.

Testing Algorithm Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Connective Tissue Disease Cascade (CTDC) in Special Instructions

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Double-stranded DNA (dsDNA) antibodies are systemic lupus erythematosus (SLE)-specific antibodies and are part of the immunology domain of the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (1) as well as a previous guidance on SLE diagnosis.(2) The Crithidia luciliae indirect immunofluorescence test (CLIFT) is widely used as a confirmatory test following a positive dsDNA IgG result obtained by a solid-phase immunoassay due to its structural or analytical specificity.(3-5)

 

The CLIFT (dsDNA) test is indicated in patients who are positive for anti-cellular antibody (also known as antinuclear antibody [ANA]) homogeneous pattern (6) using HEp-2 substrate by indirect immunofluorescence assay (IFA) following a positive result for dsDNA IgG using a solid-phase immunoassay (eg, enzyme-linked immunosorbent assay or multiplex bead assay).(3,4) A positive CLIFT result is usually associated with the presence of moderate-to-high affinity dsDNA IgG antibodies. The CLIFT result may be negative and the immunoassay positive for dsDNA IgG in SLE patients with inactive (remission) disease or in patients with early disease.(3,4,7) Discordant results between CLIFT and solid-phase immunoassays may also be due to differences in the structural specificities of DNA analytes as well as the absence reliable reagents to harmonize available clinical tests.(3,5,8)

 

A minority of SLE patients may test negative using HEp-2 by IFA for nuclear antibodies.(9) Testing antibodies associated with the HEp-2 IFA cytoplasmic pattern such as ribosomal P IgG autoantibodies may be useful if features of neuropsychiatric disease are present.(9) Alternatively, patients may be tested for Smith, ribonuclear protein (RNP), sulfosalicylic acid (SSA)-52 and SSA-60 antibodies.(6,9)

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Only orderable as reflex. For more information see ADNAR / DNA Double-Stranded (dsDNA) Antibodies with Reflex, IgG, Serum.

 

Negative

Interpretation Provides information to assist in interpretation of the test results

A positive result for double-stranded DNA (dsDNA) IgG antibodies in the appropriate clinical context is highly suggestive of systemic lupus erythematosus (SLE). The presence of dsDNA IgG antibodies detected using the Crithidia luciliae indirect immunofluorescence test is highly specific for SLE with moderate sensitivity. A negative result does not rule out a diagnosis of SLE.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

IgG antibodies to double-stranded DNA (dsDNA) by Crithidia luciliae indirect immunofluorescence test (CLIFT) is reported qualitatively (positive or negative). For semiquantitative assessment of IgG antibodies to dsDNA, see results from ADNA / Double-stranded Antibodies, IgG, Serum.

 

A weak positive result dsDNA IgG by enzyme-linked immunosorbent assay with a CLIFT negative result may be suggestive of early disease, inactive disease, or a false positive result.

 

A positive result for IgG antibodies to dsDNA by Crithidia luciliae may occur in patients with diseases other than systemic lupus erythematosus (SLE).

 

A negative result does not exclude a diagnosis of SLE.

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Aringer M, Costenbader K, Daikh D, et al: European league against rheumatism/American College of Rheumatology Classification Criteria for systemic lupus erythematosus. Arthritis Rheumatol. 2019 Sep;71(9):1400-1412. doi: 10.1002/art.40930

2. Petri M, Orbai AM, Alarcón GS, et al: Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8): 2677-2686. doi: 10.1002/art.34473

3. Enocsson H, Sjowall C, Wirestam L, et al: Four anti-dsDNA antibody assays in relation to systemic lupus erythematosus disease specificity and activity. J Rheumatol. 2015 May;42(5):817-825. doi: 10.3899/jrheum.140677

4. Sarbu MI, Salman-Monte TC, Munoz PR, Lisbona MP, Bernabe MA, Carbonell J: Differences between clinical and laboratory findings in patients with recent diagnosis of SLE according to the positivity of anti-dsDNA by the Crithidia luciliae method. Lupus. 2015 Oct;24(11):1198-1203. doi: 10.1177/0961203315573852

5. Rekvig OP: Autoimmunity and SLE: factual and semantic evidence-based critical analyses of definitions, etiology, and pathogenesis. Front Immunol. 2020 Oct 6;11:569234. doi: 10.3389/fimmu.2020.569234

6. Damoiseaux J, Andrade LEC, Carballo OG, et al: Clinical relevance of HEp-2 indirect immunofluorescent patterns: the International Consensus on ANA patterns (ICAP) perspective. Ann Rheum Dis. 2019 Jul;78(7):879-889. doi: 10.1136/annrheumdis-2018-214436

7. 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

8. Fox BJ, Hockley J, Rigsby P, Dolman C, Meroni PL, Ronnelid 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

9. Choi MY, Clarke AE, St Pierre Y, et al: Antinuclear antibody-negative systemic lupus erythematosus in an international inception cohort. Arthritis Care Res (Hoboken). 2019 Jul;71(7):893-902. doi: 10.1002/acr.23712

Special Instructions Library of PDFs including pertinent information and forms related to the test