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Test Code ADNA1 Double-Stranded DNA (dsDNA) Antibodies, IgG, 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.


Secondary ID

620809

Useful For

Evaluating patients with clinical features or at-risk for systemic lupus erythematosus (SLE)

 

Monitoring disease activity, as an adjunct test, in patients with SLE previously positive for double-stranded DNA IgG antibodies

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Specimen Type

Serum

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

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

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Reference Values

<100 IU/mL (negative)

≥100 IU/mL (positive)

Negative is considered normal.

Reference values apply to all ages.

Interpretation

A positive result for double-stranded DNA (dsDNA) IgG antibodies in the appropriate clinical context is suggestive of systemic lupus erythematosus (SLE). The performance characteristics of dsDNA IgG antibodies in SLE is dependent on the immunological method used for their detection, the patient's disease state including clinical manifestations, and demographics.

 

Weak-positive dsDNA IgG antibody results have a low-positive predictive value for SLE.

 

Negative results do not rule out a diagnosis of SLE.

Method Description

The test kit contains 12 microtiter strips each with 8 break-off reagent wells coated with double-stranded DNA (dsDNA). In the first reaction step, diluted patient samples, calibrators and controls are incubated in the wells. Anti-dsDNA antibodies will bind to the antigens coated in the microtiter wells. The wells are washed to remove any unbound proteins and non-specific antibodies. In a second reaction step, rabbit anti-human IgG-HRP enzyme conjugate is added to each well. The enzyme conjugate will bind to any wells that have human IgG binding to the dsDNA antigen. The wells are washed to remove any unbound HRP enzyme conjugate. 3,3,5,5, tetramethylbenzidine (TMB) enzyme substrate is added. If the HRP enzyme is present in the well (positive reaction), the HRP enzyme will react with the TMB substrate and produce a blue color. After an additional incubation time to allow the color development, a stop solution is added which turns the blue color yellow and inhibits further color development to allow for stable spectrophotometric reading. The test strips are placed in a microplate reader and the optical density of the color is measured. The amount of antigen specific bound antibody is proportional to the color intensity.(Package insert: Anti-dsDNA-NcX ELISA (IgG). EUROIMMUN; 7/8/2020)

Day(s) Performed

Monday through Saturday

Report Available

2 to 4 days

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

86225

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ADNA1 dsDNA Ab, IgG, S 33799-8

 

Result ID Test Result Name Result LOINC Value
ADNA1 dsDNA Ab, IgG, S 33799-8

Testing Algorithm

For more information see First-Line Screening for Autoimmune Liver Disease Algorithm.

Forms

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