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Test Id : CRITH

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

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Overview

Test Catalog

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

Method Name
A short description of the method used to perform the test

Indirect Immunofluorescence

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

dsDNA Ab by Crithidia IFA, IgG, S

Aliases
Lists additional common names for a test, as an aid in searching

Anti-DNA

Anti-ds (Anti-Double Stranded) DNA

ANTI-dsDNA ANTIBODY, IgG

Antibody to ds-DNA

Antibody to Native DNA (n-DNA)

Connective Tissue Disease Activity Assessment (2 tests)

Connective Tissue Disease Autoantibody Panel (2 tests)

DNA Double Stranded (ds-DNA) Antibody

DNA, Anti

Double Stranded DNA

ds-DNA Antibody

IgG Anti-DS DNA Antibody

IgG Autoantibodies to Double Stranded (ds)DNA

LUPUS

Native Anti-DNA

Native DNA

SLE (Systemic Lupus Erythematosus)

Systemic Lupus Erythematosus (SLE)

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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 Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

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

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), 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.

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 exclude 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 ADNA1 / Double-stranded DNA (dsDNA) Antibodies, IgG, Serum.

 

A positive result dsDNA IgG by enzyme-linked immunosorbent assay (ELISA) 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 in the absence of anti-dsDNA IgG by ELISA is also likely. In the absence of a positive homogeneous pattern antinuclear antibodies detected by indirect immunofluorescence, this autoantibody profile 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. 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

Method Description
Describes how the test is performed and provides a method-specific reference

Autoantibodies in the test specimen bind to the kinetoplast of Crithidia luciliae, a flagellate parasite which is bound to the slide. The kinetoplast is a complex network of interlocking circular double-stranded DNA molecules and is the substrate of this test. Washing removes excess serum from the substrate. Fluorescein conjugated antiserum added to the substrate attaches to the bound autoantibody. After a second washing step to remove excess conjugate, the substrate is cover slipped and viewed for fluorescent patterns with a fluorescent microscope. Observation of specific fluorescent patterns on the substrate indicates the presence of autoantibodies in the test sample.(Package insert: Bio-Rad Kallestad Crithidia luciliae Substrate. Bio-Rad Laboratories; 06/2015)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
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Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86255

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

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
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
62925 dsDNA Ab by Crithidia IFA, IgG, S In Process
37268 Crithidia Interpretation 69048-7

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports