ANA Multiplex, with Reflex to dsDNA

Test Code

10547

CPT Codes
86038

Includes

If ANAchoice® Screen is positive, then ds-DNA will be performed at an additional charge (CPT code(s): 86225)

Preferred Specimen

1 mL serum

Minimum Volume

0.5 mL

Transport Container

Transport tube

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 4 days
Refrigerated: 7 days
Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Gross hemolysis • Grossly lipemic • Grossly icteric

Methodology
Immunoassay (IA)

Setup Schedule

Set up: Mon-Sat; Report available: 1-3 days

Reference Range

ANAchoice® Screen

Negative

Clinical Significance

This multiplex immunoassay detects common antinuclear antibodies (ANAs) that are associated with autoimmune diseases. With a reflex to double-stranded DNA (dsDNA), this test may aid in the evaluation of systemic lupus erythematosus (SLE). Because of its limited sensitivity compared to that of ANA immunofluorescence-based tests, multiplex immunoassay is not the preferred assay for ANA testing [1].

This multiplex immunoassay identifies antibodies to dsDNA, chromatin, ribosomal protein, SSA, SSB, Sm, Sm/RNP, RNP, Scl-70, Jo-1, and centromere B. A positive result indicates the presence of at least one of these autoantibodies. These autoantibodies have been associated with several autoimmune diseases, including SLE, systemic sclerosis, mixed connective tissue disease, polymyositis, and Sjogren syndrome. Antibodies to dsDNA are highly specific for SLE and may be detected before flares of the disease [2]. The 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria include antibodies to dsDNA in their immunology domains and criteria for SLE [3].

A negative result of this test indicates none of the component autoantibodies were detected but does not rule out the autoimmune diseases characterized by other autoantibodies, such as autoimmune hepatitis and primary biliary cholangitis. The classic ANA immunofluorescence assay on human epithelial type 2 cells, an assay that can detect up to 150 antibodies, is considered by the ACR as the current gold standard for ANA testing [1].

The results of this test should be interpreted in the context of pertinent clinical and family history and physical examination findings.

References
1. Methodology of testing for antinuclear antibodies (position statement). 2009. American College of Rheumatology. Updated December 2019. Accessed May 15, 2023. https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/blta48818378bc89445/acr-position-statement-methodology-testing-antinuclear-antibodies.pdf
2. Tozzoli R, et al. Am J Clin Pathol. 2002;117(2):316-324.
3. Aringer M, et al. Ann Rheum Dis. 2019;78(9):1151-1159.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.