ANA Screen, IFA, with Reflex to Titer and Pattern/Lupus Panel 2

Cleveland HeartLab A, Test

NEW YORK DOH APPROVED: YES

CPT Code: 86038, 86225, 86235 (x5)
Order Code: 29839
Includes: ANA Screen, IFA, with Reflex to Titer and Pattern, DNA (ds) Antibodies, Scleroderma Antibodies (SCL-70), Sm and Sm/RNP Antibodies, and Sjogren’s Antibodies (SSA, SSB).
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
Preferred Volume:  5.0 mL
Minimum Volume:  2.0 mL
Container: Gel-barrier tube (SST, Tiger Top)

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.

Transport: Store serum at 2°C to 8°C after collection and ship the same day per packaging instructions included with the provided shipping box.

Stability:

Ambient (15-25°C): 4 days
Refrigerated (2-8°C):
7 days
Frozen (-20°C):
30 days

Causes for Rejection: Gross hemolysis; Grossly lipemic; Grossly icteric

Methodology: Immunoassay

Turn Around Time:  2 to 3 days

Reference Range: See Laboratory Report

Clinical Significance: This panel supports the evaluation of systemic lupus erythematosus (SLE) and related autoimmune diseases, such as mixed connective tissue disease, systemic sclerosis, and Sjogren syndrome. However, testing for subserologies in the absence of a positive antinuclear antibody (ANA) result and clinically suspected autoimmune disease is generally not recommended [1].

This panel simultaneously tests for ANAs with an immunofluorescence assay (IFA) and 6 specific autoantibodies associated rheumatic and related diseases. The ANA testing has high sensitivity (97%) for SLE but limited specificity (34%) [2]. Thus, a positive ANA test result does not exclude other autoimmune diseases with similar clinical features [3]. Testing for specific autoantibodies, as well as other biomarkers associated with these autoimmune diseases, in a panel may expedite the evaluation of SLE.

Although individuals with negative results on the ANA IFA usually also have negative results for specific ANAs, Jo-1 antibody may be detected in ANA IFA-negative patients with some types of myositis, and SSA antibody may be detected in some ANA IFA-negative patients with lupus or Sjogren syndrome [1].

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

References

  1. Yazdany J, et al. Arthritis Care Res (Hoboken). 2013;65(3):329-339.
  2. Petri M, et al. Arthritis Rheum. 2012;64(8):2677-2686.
  3. Kavanaugh A, et al. Arch Pathol Lab Med. 2000;124(1):71-81.

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.