Ordering Recommendation

Secondary screening for systemic lupus erythematosus (SLE) based on ANA results.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.5 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Plasma. Contaminated, hemolyzed, or severely lipemic specimens.

Remarks
Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 month (avoid repeated freeze/thaw cycles)

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay/Semi-Quantitative Indirect Fluorescent Antibody

Performed

Sun-Sat

Reported

1-3 days

Reference Interval

Test Number
Components
Reference Interval (IUs)
  Double-Stranded DNA (dsDNA) Ab IgG ELISA 24 IUs or less

Interpretive Data

Positivity for anti-double stranded DNA (anti-dsDNA) IgG antibody is a diagnostic criterion of systemic lupus erythematosus (SLE). Specimens are initially screened by enzyme-linked immunosorbent assay (ELISA). If ordered as reflex (0050215), positive ELISA results (>24 IU) will be reflexed to a highly specific IFA titer (Crithidia luciliae indirect fluorescent test [CLIFT]) for confirmation. Some patients with early or inactive SLE may be positive for anti-dsDNA IgG by ELISA but negative by CLIFT. If the patient is negative by CLIFT but positive by ELISA and clinical suspicion remains, consider antinuclear antibody (ANA) testing by IFA. Additional information and recommendations for testing may be found at https://arupconsult.com/content/systemic-lupus-erythematosus.


Components
Interpretation
dsDNA (Double Stranded DNA) Antibody, IgG 24 IUs or less  :  Negative
25 to 30 IUs     :  Borderline Positive
30 to 60 IUs     :  Low Positive
60 to 200 IUs   :  Positive
201 IUs or greater :  Strong Positive

Compliance Category

FDA

Note

If dsDNA IgG antibody is detected, the result will be confirmed by Double-Stranded DNA (dsDNA) Antibody, IgG by IFA (using Crithidia luciliae). Additional charges apply.

Hotline History

N/A

CPT Codes

86225; if reflexed, add 86256

Components

Component Test Code* Component Chart Name LOINC
0050215 Double-Stranded DNA (dsDNA) Ab IgG ELISA 58465-6
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • anti-DNA
  • Anti-dsDNA Antibody
  • Anti-Native DNA
  • Antibody to ds-DNA
  • Crithidia luciliae
  • DNA ds Ab
  • Double stranded DNA antibody
  • ds DNA Ab
  • ds-DNA
  • ds-DNA IgG
  • dsDNA reflex
  • dsDNA reflex panel
  • Native double-stranded DNA antibody
Double-Stranded DNA (dsDNA) Antibody, IgG by ELISA with Reflex to dsDNA Antibody, IgG by IFA