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

Reporting Name

dsDNA Ab by Crithidia IFA, IgG, S

Specimen Type

Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.3 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Reference Values

Negative

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86255

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CRITH dsDNA Ab by Crithidia IFA, IgG, S 58466-4

 

Result ID Test Result Name Result LOINC Value
62925 dsDNA Ab by Crithidia IFA, IgG, S In Process
37268 Crithidia Interpretation 69048-7

Method Name

Indirect Immunofluorescence

Useful For

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

 

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

Interpretation

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 exclude a diagnosis of SLE.

Clinical Reference

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

2. Petri M, Orbai AM, Alarcon GS, et al. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012;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;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;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;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;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;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;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;71(7):893-902. doi:10.1002/acr.23712

Day(s) Performed

Monday through Friday

Report Available

2 to 4 days

Specimen Minimum Volume

See Specimen Required