Test ID: ADNA
DNA Double-Stranded (dsDNA) Antibodies, IgG, Serum
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Evaluating patients with signs and symptoms consistent with lupus erythematosus (LE)
Monitoring patients with documented LE for flares in disease activity
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
See Connective Tissue Disease Cascade (CTDC) in Special Instructions.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
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
LE (Lupus Erythematosus) Prep
LUPUS
Native Anti-DNA
Native DNA
SLE (Systemic Lupus Erythematosus)
Systemic Lupus Erythematosus (SLE)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross OK |
| Lipemia | Mild OK; Gross OK |
| Icterus | Mild OK; Gross OK |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 21 days |
| Frozen | 21 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Double-stranded (ds, native) DNA (dsDNA) antibodies of the IgG class are an accepted criterion (American College of Rheumatology) for the diagnosis of systemic lupus erythematosus (SLE).(1-3) dsDNA antibodies are detectable in approximately 85% of patients with untreated SLE, and are rarely detectable in other connective tissue diseases. Weakly-positive results caused by low-avidity antibodies to dsDNA are not specific for SLE and can occur in a variety of diseases.
Testing for IgG antibodies to dsDNA is indicated in patients who have a positive test for antinuclear antibodies (ANA) along with signs and symptoms that are compatible with the diagnosis of SLE.(2) If the ANA test is negative, there is no reason to test for antibodies to dsDNA.(2)
The levels of IgG antibodies to dsDNA in serum are known to fluctuate with disease activity in lupus erythematosus, often increasing prior to an increase in inflammation and decreasing in response to therapy.(1,2)
See Connective Tissue Disease Cascade (CTDC) in Special Instructions.
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
A positive test result for double-stranded DNA (dsDNA) antibodies is consistent with the diagnosis of systemic lupus erythematosus.
A reference range study conducted at the Mayo Clinic demonstrated that, within a cohort of healthy adults (n=120), no individuals between the ages of 18 and 60 (n=78) had detectable anti-dsDNA antibodies. Above the age of 60 (n=42), 11.9% of individuals (n=5) had a borderline result for dsDNA antibodies and 4.8% of individuals (n=2) had a positive result.
Increases of at least 25% in the level of IgG antibodies to dsDNA may indicate an exacerbation of disease.
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 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 lupus erythematosus (LE). Clinical flares of disease in patients with LE may not be accompanied by changes in the levels of dsDNA antibodies.
Positive results may occur in patients with diseases other than LE.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Tran T, Pisetsky D: Detection of anti-DNA antibodies. In Manual of Molecular and Clinical Laboratory Immunology, 7th edition. Edited by B Detrick, R Hamilton, J Folds. Washington, DC, ASM Press, 2006, Chapter 115, pp 1027-1032
2. Kavanaugh A, Tomar R, Reveille J, et al: Guidelines for use of the antinuclear antibody test and tests for specific autoantibodies to nuclear antigens. Arch Pathol Lab Med 2000;124:71-81
3. Tan EM, Cohen AS, Fries JF, et al: The 1982 revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1982;25:1271-1277
Method Description Describes how the test is performed and provides a method-specific reference
Microwells are precoated 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 antihuman 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 produce, 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, San Diego, CA 04/2010)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Saturday; 4 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86225
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| ADNA | DNA Double-Stranded Ab, IgG, S | 33800-4 |
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