Sjogren's Panel with Rheumatoid Factor and ANA, IFA with Reflex

Test Code

90077

CPT Codes
86038, 86235 (x2), 86431

Includes

ANA Screen, IFA, with Reflex to Titer and Pattern
Sjogren's Antibodies (SS-A, SS-B)
Rheumatoid Factor

If ANA Screen, IFA is positive, then ANA Titer and Pattern will be performed at an additional charge (CPT code(s): 86039).

Preferred Specimen

2 mL serum

Minimum Volume

1.5 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 • Grossly icteric • Microbial contamination may interfere

Methodology
Immunoassay (IA) • Immunofluorescence Assay (IFA) • Immunoturbidimetric

Setup Schedule

See individual assays

Clinical Significance

This panel can be helpful in the diagnosis of Sjogren syndrome by simultaneously testing for antinuclear antibodies (ANAs) with an immunofluorescence assay (IFA), performed on human epithelial type 2 (HEp-2) cells, as well as SSA antibodies, SSB antibodies, and rheumatoid factor (RF). 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 [1]. Knowing the ANA titer and pattern can be helpful in interpreting positive ANA results [2]. Individuals with negative results on the ANA IFA usually also have negative results on specific autoantibodies. However, SSA antibody may be detected in some ANA IFA-negative patients with lupus or Sjogren syndrome [3].

The 2012 ACR classification criteria for Sjogren syndrome indicate that testing for SSA or SSB antibody has the highest sensitivity and specificity, and that a positive RF result in addition to an ANA titer ≥1:320 is consistent with Sjogren syndrome [4]. However, the 2016 ACR/European League Against Rheumatism (EULAR) classification criteria for Sjogren syndrome do not include SSB/La, RF, and ANA titer, because studies showed that these markers do not add sufficient value to SSA/Ro testing [5].

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. Tozzoli R, et al. Am J Clin Pathol. 2002;117(2):316-324.
3. Yazdany J, et al. Arthritis Care Res (Hoboken). 2013;65(3):329-339.
4. Shiboski SC, Arthritis Care Res (Hoboken). 2012;64(4):475-487.
5. Shiboski CH, et al. Ann Rheum Dis. 2017;76(1):9-16.

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.