ANA Screen, IFA, with Reflex to Titer and Pattern/Lupus Panel 3

CPT Code: 86038, 86225, 86235 (x5), 86160 (x2), 86162
Order Code: 19881
Includes: ANA Screen, IFA, with Reflex to Titer and Pattern, DNA (ds) Antibody, Sjogren’s Antibodies (SS-A, SS-B), Sm Antibody, RNP Antibody, Chromatin (Nucleosomal) Antibody, Complement Component C3c and C4c, and Complement, Total (CH50).
If ANA Screen, IFA is positive, then ANA Titer and Pattern will be performed at an additional charge (CPT code(s): 86039).

Alternative Names: Systemic Lupus Erythematosus (SLE), FANA, Fluorescent ANA, Progressive ANA, Hep-2, Antinuclear Antibody Screen
ABN Requirement: No
Specimen: Serum
Volume:  4.0 mL (1.0 mL serum collected in each of four separate tubes)
Minimum Volume:  2.0 mL (0.5 mL serum collected in each of four separate tubes)
Container:
Preferred: Gel-barrier tube (SST, Tiger Top)
          Alternate: Red Top (no gel barrier) tube

Collection:

  1. Collect and label sample according to standard protocols.
  2. Gently invert tube 5 times immediately after draw. DO NOT SHAKE.
  3. Allow blood to clot 30 minutes.
  4. Centrifuge for 10 minutes.
  5. Immediately aliquot serum into four separate labeled transport tubes and freeze at -20°C.

Transport: Store serum at -20°C after collection and ship frozen the same day per packaging instructions included with the provided shipping box.

Stability:

Ambient (15-25°C): Not Acceptable
Refrigerated (2-8°C): Not Acceptable
Frozen (-20°C): 21 days

Causes for Rejection: Specimens other than serum; specimen received thawed; improper labeling; samples not stored properly; samples older than stability limits; gross hemolysis; lipemia; gross icterus; microbial contamination

Methodology: See Individual Tests

Turn Around Time:  3 to 4 days

Reference Range: See Laboratory Report

Clinical Significance: This panel can be helpful in the diagnosis and management of systemic lupus erythematosus (SLE). The panel simultaneously tests for antinuclear antibodies (ANAs) with an immunofluorescence assay (IFA), performed on human epithelial type 2 (HEp-2) cells, as well as 6 specific autoantibodies associated with SLE and 3 biomarkers associated with disease activity. For specimens with positive ANA IFA results, reflex testing for ANA titer and pattern is performed.

The ANA testing has high sensitivity (97%) for SLE but limited specificity (34%) [1]. Anti-dsDNA and anti-Sm antibodies are less sensitive but more specific; tests for both antibodies are included in classification criteria for SLE [2]. Anti-chromatin antibodies have relatively high sensitivity and specificity. Although antibodies to SSA and SSB may also be seen in Sjogren Syndrome and anti-RNP is a marker of mixed connective tissue disease, these antibodies are also frequently present in SLE and may be helpful.

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

References

  1. Petri M, et al. Arthritis Rheum. 2012;64(8):2677-2686.
  2. Aringer M, et al. Ann Rheum Dis. 2019;78(9):1151-1159.

The CPT codes provided 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 payer being billed.