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Antinuclear antibody (ANA) testing options

ANA testing can help in the differential diagnosis of many autoimmune disease states, including systemic lupus erythematosus (SLE), drug-induced SLE, mixed connective tissue disease (MCTD), Sjögren syndrome, limited scleroderma (CREST), diffuse scleroderma, rheumatoid arthritis (RA) and autoimmune thyroid disease.¹⁻²

At Labcorp, our ANA tests are performed by immunofluorescence assay (IFA)
 

Gold standard

The American College of Rheumatology (ACR), ANA task force and the International Consensus on ANA Patterns (ICAP) recommend the IFA as the gold standard for ANA testing 3,4

Consistency

Seven patterns are identified automatically, including the titer result5

High-quality results

The detailed review process includes technologist confirmation of all results

ANA by IFA Testing

A positive ANA result may occur in healthy individuals (low titer) or may be associated with a variety of diseases.6,7 Labcorp offers both comprehensive diagnostic profiles and monospecific assays for individual autoantibodies to provide diagnostic and potential prognostic utility for several autoimmune diseases.

ANA by IFA is only the first step in diagnosis. We also offer these next steps to help you and your patients find the answers you need.

The Anti-Dense Fine Speckled Protein 70 kDa (DFS70) Ab may help identify individuals who do not have an ANA-associated autoimmune rheumatic disease (AARD) especially in the absence of significant clinical findings.8

The Anti-ENA6 Plus DFS70Ab is a unique screening profile with the novel Anti-DFS70 that may help identify SLE, MCTD, Sjögren syndrome, systemic sclerosis, and idiopathic myopathy (IIM), as well as contributes to the inclusion or exclusion of these AARDs.9 Positive Anti-DFS70, especially when positive in isolation, confers a likelihood ratio of 10.9 for the absence of systemic autoimmune rheumatic disease (SARD).9

Access Our Comprehensive Autoimmune Portfolio

Autoimmune diseases commonly share clinical manifestations, similar subphenotypes and non-specific autoantibodies. Whether you are a rheumatologist or a primary care provider, we strive to help you differentiate between autoimmune states and obtain an accurate diagnosis with our comprehensive suite of autoimmune testing profiles.

References

1. Fenger M, Wiik A, Høier-Madsen M, et al. Detection of antinuclear antibodies by solid-phase immunoassays and immunofluorescence assays. Clin Chem. 2004;50(11):2141-2147.

2. Tebo AE. Recent approaches to optimize laboratory assessment of antinuclear antibodies. Clin Vaccine Immunol. 2017;24(12):e00270-17. https://doi.org/10.1128/CVI.00270-17.

3. Meroni PL and Shur PH. ANA screening: an old test with new re commendations. Ann Rheum Dis. 2010;69:1420-1422.

4. Chan EK, Damoiseaux J, Carballo OG, et al. Report of the First International Consensus on Standardized Nomenclature of Antinuclear Antibody HEp-2 Cell Patterns 2014-2015. Front Immunol. 2015;6:412. doi: 10.3389/fimmu.2015.00412. PMID: 26347739; PMCID: PMC4542633.

5. EUROIMMUN Systems for full automation of IIFT. Luebeck, Germany: Euroimmun; January 2018.

6. Mariz HA, Sato EI, Rodrigues SH, et al. Pattern on the antinuclear antibody-HEp-2 test is a critical parameter for discriminating antinuclear antibody-positive healthy individuals and patients with autoimmune rheumatic diseases. Arthritis Rheum. 2010;63(1):191-200.

7. Agmon-Levin N, Damoiseaux J, Kallenberg C, et al. International recommendations for the assessment of autoantibodies to cellular antigens referred to as anti-nuclear antibodies. Ann Rheum Dis. 2014;73(1):17-23.

8. Conrad K, Röber N, Andrade LEC, Mahler M. The clinical relevance of anti-DFS70 autoantibodies. Clin Rev Allergy Immunol. 2017;52(2):202-216. PubMed 27350273.

9. Fitch-Rogalsky C, Steber W, Mahler M, et al. Clinical and serological features of patients referred through a rheumatology triage system because of positive antinuclear antibodies. PLoS One. 2014: 4;9(4):e93812. PubMed 2470582.

10. Mahler M, Parker T, Peebles CL, et al. Anti-DFS70/LEDGF antibodies are more prevalent in healthy individuals compared to patients with systemic autoimmune rheumatic diseases. J Rheumatol 2012;39:2104-2110.