Scleroderma Antibody (Scl-70)

Laboratory assay overview

This panel can be helpful in the diagnosis of autoimmune rheumatic diseases, including systemic lupus erythematosus, systemic sclerosis, Sjogren syndrome, mixed connective tissue disease, and rheumatoid arthritis. All specimens are screened for antinuclear antibodies (ANAs) with multiplex immunoassay. This approach simultaneously detects antibodies to dsDNA, chromatin, ribosomal protein, SSA, SSB, Smith (Sm), Sm/RNP, RNP, Scl-70, Jo-1, and centromere B. A positive result indicates the presence of at least 1 of these antibodies; a negative result indicates that none of the component antibodies were detected. Regardless of the result, this panel also detects antibodies to dsDNA, Sm, Sm/RNP, Scl-70, SSA and SSB as well as rheumatoid factor. ANA immunofluorescence assay (IFA) on HEp-2 cells is considered by the American College of Rheumatology as the current gold standard for ANA screening because of its overall high sensitivity for several autoimmune diseases [1]. However, because patients with other diseases and healthy individuals may be positive for ANA IFA, using immunoassays for screening may be more specific for a systemic rheumatic disorder [2]. On the other hand, multiplex immunoassay screening cannot rule out autoimmune diseases characterized by other antibodies, such as autoimmune hepatitis and primary biliary cholangitis, which may be positive for ANA IFA. 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. Fritzler MJ, et al. J Appl Lab Med. 2022;7:357-361.

Laboratory assay overview

This panel can be helpful in the diagnosis of systemic rheumatic disorders and other autoimmune diseases. Although the test for antinuclear antibodies (ANA) is strongly associated with systemic lupus erythematosus (SLE), the laboratory evaluation for individuals with clinical suspicion of a variety of autoimmune diseases often begins with an ANA screen. This panel simultaneously tests for ANA (using immunofluorescence) as well as the important specific autoantibodies associated with a positive ANA. It also includes testing for complement proteins, rheumatoid arthritis, Sjogren's syndrome, systemic sclerosis, polymyositis, anti-phospholipid antibody syndrome, and autoimmune thyroid disease.

Laboratory assay overview

This panel can be helpful in the diagnosis of systemic lupus erythematosus (SLE) and several other autoimmune diseases, including mixed connective tissue disease, Sjogren syndrome, systemic sclerosis, and autoimmune thyroid disease. The panel simultaneously tests for antinuclear antibodies (ANAs) with an immunofluorescence assay (IFA), performed on human epithelial type 2 (HEp-2) cells, and 11 biomarkers associated with these conditions. For specimens with positive ANA IFA results, reflex testing for ANA titer and pattern is performed. The ANA testing has high sensitivity (97%) for SLE but limited specificity (34%) [1]. Thus, a positive ANA test does not exclude other autoimmune diseases with similar clinical features [2]. Testing for specific antibodies in a panel may expedite the evaluation of SLE but is generally not recommended [3]. The results of this test should be interpreted in the context of pertinent clinical and family history and physical examination findings. References 1. Petri M, et al. Arthritis Rheum. 2012;64(8):2677-2686. 2. Kavanaugh A, et al. Arch Pathol Lab Med. 2000;124(1):71-81. 3. Yazdany J, et al. Arthritis Care Res (Hoboken). 2013;65(3):329-339.