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ANA Screen,IFA, with Reflex to Titer and Pattern/Sjogren's Panel 2
Test CodeCPT Codes
86038, 86431, 86235 (x2), 86381, 86376
Includes
Sjogren's Antibody (SS-A, SS-B)
Rheumatoid Factor
Thyroid Peroxidase Antibody (TPO)
Mitochondrial Antibody with Reflex to Titer
If ANA Screen, IFA is positive, then ANA Titer and Pattern will be performed at an additional charge (CPT code(s): 86039).
If Mitochondrial Antibody Screen is positive, then Mitochondrial Antibody Titer will be performed at an additional charge (CPT code(s): 86381).
Preferred Specimen
Minimum Volume
Transport Temperature
Specimen Stability
Room temperature: 4 days
Refrigerated: 7 days
Frozen: 28 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
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, rheumatoid factor (RF), thyroid peroxidase (TPO) antibodies, and anti-mitochondrial antibodies (AMAs). For specimens with positive ANA IFA results, reflex testing for ANA titer and pattern is performed. For specimens with positive AMA results, reflex testing for AMA titer 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 fluorescent staining pattern can be helpful in interpreting positive 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].
Primary Sjogren syndrome is associated with an increased frequency of certain other autoimmune diseases [6]. Detecting characteristic markers, such as AMAs for primary biliary cholangitis and TPO antibodies for autoimmune thyroid disease, may aid in the evaluation of coexisting autoimmune diseases.
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.
6. St. Clair EW, et al. Sjogren's Syndrome. In: Firestein GS, et al, eds. Kelley & Firestein's Textbook of Rheumatology. 10th ed. Elsevier; 2017.
