CPT Code: 86038
Order Code: 90072
Includes: If the ANA Screen, IFA is positive, then ANA Titer and Pattern (CPT code(s): 86039), DNA (ds) Antibody (CPT code(s): 86225), Sm Antibody (CPT code(s): 86235) and Chromatin (Nucleosomal) Antibody (CPT code(s): 86235) will be performed at an additional charge.
Alternative Names: Systemic Lupus Erythematosus (SLE), FANA, Fluorescent ANA, Progressive ANA, Hep-2, Antinuclear Antibody Screen
ABN Requirement: No
Volume: 2.0 mL
Minimum Volume: 1.0 mL
Container: Gel-barrier tube (SST, Tiger Top)
- Collect and label sample according to standard protocols.
- Gently invert tube 5 times immediately after draw. DO NOT SHAKE.
- Allow blood to clot 30 minutes.
- 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.
Ambient (15-25°C): 4 days
Refrigerated (2-8°C): 7 days
Frozen (-20°C): 30 days
Causes for Rejection: Specimens other than serum; improper labeling; samples not stored properly; samples older than stability limits; gross hemolysis; gross lipemia; microbial contamination
Methodology: See Individual Tests
Turn Around Time: 2 to 3 days
Reference Range: See Laboratory Report
Clinical Significance: This panel can be helpful in the diagnosis of systemic lupus erythematosus (SLE) by testing for antinuclear antibodies (ANAs) with an immunofluorescence assay (IFA) performed on human epithelial type 2 (HEp-2) cells. For specimens with positive ANA IFA results, reflex testing for ANA titer and pattern, double stranded DNA (dsDNA) antibody, Smith (Sm) antibody, and chromatin antibody is performed.
ANA IFA on HEp-2 cells is considered by the American College of Rheumatology (ACR) as the current gold standard because of its overall high sensitivity for several autoimmune diseases . Knowing the ANA titer and fluorescent staining pattern can be helpful in interpreting positive results. ANA testing has high sensitivity (97%) for SLE but limited specificity (34%) . Thus, a positive ANA test does not exclude other autoimmune diseases with similar clinical features.
SLE classification criteria include both ANA and SLE-specific antibodies (ie, antibodies to dsDNA and Sm), but the relative importance of each marker can vary by guideline. The 2019 classification criteria from the European League Against Rheumatism (EULAR) and the ACR require ANA be detected before other clinical and laboratory criteria are considered . In contrast, the 2012 classification criteria from the Systemic Lupus Erythematosus International Collaborating Clinics places equal weight on a positive result for ANA, dsDNA antibody, and Sm antibody. Though not included in the classification criteria, chromatin antibodies have relatively high sensitivity (64% to 69%) and specificity (92% to 99%) for SLE  and may provide value when diagnosing SLE.
The results of this test should be interpreted in the context of pertinent clinical and family history and physical examination findings.
- Methodology of testing for antinuclear antibodies (position statement). 2009. American College of Rheumatology. Updated December 2019. Accessed March 15, 2022. Methodology of Testing Antinuclear Antibodies Position Statement.pdf 2. Kavanaugh A, et al. Arch Pathol Lab Med. 2000;124(1):71-81.
- Petri M, et al. Arthritis Rheum. 2012;64(8):2677-2686.
- Aringer M, et al. Ann Rheum Dis. 2019;78(9):1151-1159.
- Cervera R, et al. Ann Rheum Dis. 2003;62(5):431-434.
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.