86038

Antinuclear antibodies (ANA) Screening

CPT code 86038 represents the laboratory analysis for Antinuclear Antibodies (ANA). ANA testing serves as a primary diagnostic tool for clinicians investigating systemic autoimmune rheumatic diseases (SARD). These antibodies are directed against various components within the cell nucleus, including DNA, histones, and nuclear proteins. The presence of ANA is highly sensitive for systemic lupus erythematosus (SLE), but it is also found in several other autoimmune conditions such as Sjögren's syndrome, scleroderma, and mixed connective tissue disease. The methodology employed for this code is typically the Indirect Immunofluorescence Assay (IFA), which is widely considered the gold standard due to its high sensitivity. In the IFA process, patient serum is applied to a substrate of human epithelial (HEp-2) cells. If ANAs are present, they bind to the nuclear material. A fluorescently tagged secondary antibody is then introduced to visualize the binding patterns under a fluorescence microscope. While IFA is traditional, many laboratories now utilize Enzyme-Linked Immunosorbent Assay (ELISA) or multiplex immunoassay (MIA) techniques for 86038. These solid-phase assays are more automated and provide objective, quantitative results, although they may vary in sensitivity compared to IFA. A positive ANA screen result is not definitive for a specific disease; rather, it indicates the need for further clinical correlation and potentially more specific antibody testing, such as anti-double-stranded DNA or anti-Smith antibodies. Because a significant percentage of the healthy population may exhibit low-level ANA positivity, the test must be ordered and interpreted within the context of the patient's symptoms, such as malar rash, photosensitivity, or joint pain.

Clinical Indications

  • Suspected Systemic Lupus Erythematosus (SLE)
  • Workup for Sjögren's syndrome
  • Evaluation of systemic sclerosis (scleroderma)
  • Diagnosis of mixed connective tissue disease (MCTD)
  • Assessment of unexplained arthritis or arthralgia
  • Investigation of Raynaud's phenomenon
  • Evaluation of autoimmune hepatitis
  • Monitoring of drug-induced lupus erythematosus
  • Screening for inflammatory myopathies like polymyositis

Procedure Steps

  1. Collect blood specimen via venipuncture using a red-top or serum separator tube (SST).
  2. Allow the blood to clot and centrifuge the specimen to separate the serum.
  3. Prepare the laboratory substrate, typically human epithelial (HEp-2) cells fixed on a glass slide.
  4. Apply diluted patient serum to the slide and incubate to allow antibodies to bind to nuclear antigens.
  5. Perform a washing step to remove unbound proteins and non-specific antibodies.
  6. Add a secondary anti-human immunoglobulin antibody conjugated with a fluorescent dye (e.g., fluorescein isothiocyanate).
  7. Incubate and perform a second wash to remove excess conjugate.
  8. Examine the slide under a fluorescence microscope to determine the presence of nuclear staining (positivity).
  9. Record the qualitative result (positive or negative) as required for the 86038 screen.

Coding Guidelines

  • Use code 86038 for the initial qualitative or semi-quantitative screening of antinuclear antibodies.
  • If the screen is positive and the laboratory protocol requires a titer and pattern determination, report 86039 (titer and pattern) instead of or in addition to 86038, depending on the specific lab process and payer-specific reflex testing rules.
  • Do not report 86038 for specific antibody tests such as anti-dsDNA (86225) or anti-Sm (86235); these are coded separately.
  • Verify if the laboratory is using IFA or ELISA/MIA methodology, as 86038 applies to both, but some local coverage determinations may specify preferred methods for certain diagnoses.
  • If multiple immunology tests are performed, ensure each is supported by clinical necessity to avoid bundling issues.

Associated ICD-10 Codes