Lupus Panel 1 with ANA, IFA with Reflex to Titer and Pattern

Test Code

90072

CPT Codes
86038

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.

Preferred Specimen

1 mL serum

Minimum Volume

0.5 mL

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 • Microbial contamination may interfere

Methodology
Immunofluorescence Assay (IFA)

Setup Schedule

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

Reference Range

ANA Screen, IFA

Negative

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 [1]. 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%) [2]. 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 [3]. 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 [4] 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.

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. Petri M, et al. Arthritis Rheum. 2012;64(8):2677-2686.
3. Aringer M, et al. Ann Rheum Dis. 2019;78(9):1151-1159.
4. Cervera R, et al. Ann Rheum Dis. 2003;62(5):431-434.

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.