Test Catalog

Test Id : ADNAR

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DNA Double-Stranded (dsDNA) Antibodies with Reflex, IgG, Serum

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Overview

Test Catalog

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

Evaluating patients with clinical features or at-risk for systemic lupus erythematosus with additional testing by indirect immunofluorescence to clarify cases of borderline enzyme-linked immunosorbent assay results

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
CRITH dsDNA Ab by Crithidia IFA, IgG, S No No

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

If the double-stranded DNA (dsDNA) result is borderline, then the dsDNA by immunofluorescence will be performed at an additional charge.

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

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

ADNAR: Enzyme-Linked Immunosorbent Assay (ELISA)

CRITH: 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 with Reflex, 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)

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

If the double-stranded DNA (dsDNA) result is borderline, then the dsDNA by immunofluorescence will be performed at an additional charge.

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

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

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

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

Forms

If not ordering electronically, complete, print, and send a General Request (T239) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.35 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

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

Evaluating patients with clinical features or at-risk for systemic lupus erythematosus with additional testing by indirect immunofluorescence to clarify cases of borderline enzyme-linked immunosorbent assay results

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

If the double-stranded DNA (dsDNA) result is borderline, then the dsDNA by immunofluorescence will be performed at an additional charge.

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

Of the systemic lupus erythematosus (SLE)-specific antibodies outlined in the immunology domain of the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE,(1) antibodies to double-stranded DNA (dsDNA) is the most common. It is also included in the Systemic Lupus International Collaborating Clinics classification criteria (SLICC) for SLE.(2) Detection of IgG antibodies to dsDNA is the most used isotype clinically.(3-5) The diagnostic performance of dsDNA IgG antibodies in SLE is variable and dependent on several factors; notably the immunological method used for their detection, the structure of the DNA, the patient’s disease state (early or active vs inactive) including specific clinical manifestations and demographics.(3-7) Weak-positive dsDNA IgG antibodies have low affinity and low avidity with variable clinical correlations for SLE.(3)

 

Testing for IgG antibodies to dsDNA is indicated in patients positive for anti-cellular antibody (ie, antinuclear antibody: ANA) homogeneous pattern using HEp-2 substrate by indirect immunofluorescence assay (IFA) along with clinical features compatible with SLE.(1,2,8). A minority of SLE patients may test negative using HEp-2 by IFA for nuclear antibodies.(8,9) Testing antibodies associated with HEp-2 IFA cytoplasmic pattern such as ribosomal P IgG autoantibodies may be useful if features of neuropsychiatric disease are present. Alternatively, patients may be tested for Smith, ribonucleoprotein, SSA-52, and SSA-60 antibodies.(8,9)

 

The levels of antibodies to dsDNA may fluctuate with SLE disease activity. Increasing antibody levels may be associated with flares while decline or negative results may indicate response to treatment or disease remission.

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.

<30.0 IU/mL (negative)

30.0-75.0 IU/mL (borderline)

>75.0 IU/mL (positive)

Negative is considered normal.

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

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

Measurements of IgG antibodies to double-stranded DNA (dsDNA) are semiquantitative. Slight changes in the levels of these antibodies should not be relied upon to predict changes in the clinical course of patients with systemic lupus erythematosus (SLE). Clinical flares of disease in patients with SLE may not be accompanied by changes in the levels of dsDNA antibodies. Thus, antibody levels alone are not sufficient to guide disease management.

 

Weak-positive results may not correlate with a diagnosis of SLE. Confirmation with Crithidia luciliae indirect immunofluorescence test (CLIFT), which is more specific for SLE may be useful to make diagnosis in certain circumstances.

 

A weak-positive dsDNA IgG result by enzyme-linked immunosorbent assay and a CLIFT-negative result may suggest early disease, remission, or false-positive results.

 

False-positive results are usually of low titers.

 

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 Sep;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 Aug;64(8):2677-86. doi: 10.1002/art.34473

3. Infantino M, Manfredi M, Merone M, et al: Analytical variability in the determination of anti-double-stranded DNA antibodies: the strong need of a better definition of the old and new tests. Immunol Res. 2018 Jun;66(3):340-347. doi: 10.1007/s12026-018-8992-9

4. Fox BJ, Hockley J, Rigsby P, Dolman C, Meroni PL, Ronnelid J, et al: 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-2019-21584

5. Ambrose N, Morgan TA, Galloway J, et al: Differences in disease phenotype and severity in SLE across age groups. Lupus. 2016 Dec;25(14):1542-1550. doi: 10.1177/0961203316644333

6. 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

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. Damoiseaux J, Coelho Andrade LE, 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

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

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

Microwells are pre-coated with calf thymus double-stranded DNA (dsDNA) antigen. The calibrators, controls, and diluted patient samples are added to the wells, and autoantibodies recognizing the dsDNA antigen bind during the first incubation. After washing the wells to remove all unbound proteins, purified peroxidase labeled goat anti-human IgG conjugate is added. The conjugate binds to the captured human autoantibody and the excess unbound conjugate is removed by a further wash step. The bound conjugate is visualized with 3,3’,5,5’ tetramethylbenzidine (TMB) substrate which gives a blue reaction product, the intensity of which is proportional to a concentration of autoantibody in the sample. Sulfuric acid is added to each well to stop the reaction. This produces a yellow end point color, which is read at 450 nm.(Package insert: QUANTA Lite dsDNA SC ELISA, INOVA Diagnostics Inc; 08/2014)

 

Confirmatory testing for borderline dsDNA results by enzyme-linked immunosorbent assay (ELISA) testing is performed by immunofluorescence assay (IFA). Autoantibodies in a test sample directed against dsDNA bind to antigens in the substrate placed on the slide-which, in this case, is Crithidia luciliae. Washing removes excess serum from the substrate. Fluorescein-conjugated (FITC) antiserum added to the substrate attaches to the bound autoantibody. After a second washing step to remove excess conjugate, the substrate has a coverslip added, and it is 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
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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.

86225

86225-CRITH (if appropriate)

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
ADNAR dsDNA Ab with Reflex, IgG, S 33799-8
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.
ADNAR dsDNA Ab with Reflex, IgG, S 33799-8

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