NEW YORK DOH APPROVED: YES
CPT Code: 86038, 86200, 86431 (86039 ANA Titer and Pattern, if reflexed)
Order Code: 90071
Includes: ANA Screen by IFA, Cyclic Citrullinated Peptide (CCP) Antibody (IgG), Rheumatoid Factor.
If ANA Screen by IFA is positive, then ANA Titer and Pattern will be performed at an additional charge (CPT Code: 86039).
ABN Requirement: No
Volume: 3.0 mL
Minimum Volume: 1.5 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: Improper labeling; samples not stored properly; samples older than stability limits; gross hemolysis; gross lipemia; microbial contamination may interfere; plasma specimen
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 autoimmune diseases with a focus on rheumatoid arthritis (RA) by simultaneously testing for antinuclear antibodies (ANAs) with an immunofluorescence assay (IFA), performed on human epithelial type 2 (HEp-2) cells, as well as the RA markers rheumatoid factor (RF) and cyclic citrullinated peptide (CCP) antibody (IgG). For specimens with positive ANA IFA results, reflex testing for ANA titer and pattern is performed.
The laboratory evaluation for individuals with clinical suspicion of autoimmune diseases often begins with an ANA screen. The classic 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 . Although RA is not generally associated with ANA, occasional patients may present with features of RA and SLE (“rhupus”) and be positive for ANA and RA markers .
This panel includes RF and CCP IgG antibody, 2 widely used laboratory markers that are included in the ACR/ European League Against Rheumatism classification criteria for RA . The combination of RF and CCP antibody provides greater sensitivity than either assay alone  and is commonly used in the diagnostic evaluation of suspected RA.
The results of this test should be interpreted in the context of pertinent clinical and family history and physical examination findings.
1. 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. Antonini L, et al. Autoimmun Rev. 2020;19(9):102612.
3. Aletaha D, et al. Arthritis Rheum. 2010;62(9):2569-2581.
4. Maksymowych WP, et al. J Rheumatol. 2014;41(11):2104-2113.
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.