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Understanding Scleroderma and Its Diagnostic Tests
In honor of those affected by scleroderma, June is recognized as Scleroderma Awareness Month, culminating in World Scleroderma Day on June 29. This day was chosen to commemorate the life of Swiss painter Paul Klee, who passed away from systemic sclerosis on June 29, 19401.
Scleroderma, also known as systemic sclerosis, is a rare autoimmune disease characterized by the hardening and tightening of the skin and connective tissues. This condition can affect not only the skin but also internal organs, such as the lungs, heart, kidneys, and digestive system. Although researchers have not yet identified the exact cause of scleroderma, they know that the disease triggers excessive collagen production, which leads to tissue fibrosis and vascular abnormalities.
As scleroderma can present with a wide range of symptoms and levels of severity, an early diagnosis is crucial for effective management and preventing complications. The diagnostic process usually includes a combination of clinical evaluation, laboratory tests, and imaging studies.
Clinical Evaluation: The first step often involves a thorough physical examination, focusing on skin changes such as thickening, tightening, and color changes. Doctors also assess symptoms like Raynaud’s phenomenon (a condition where fingers and toes change color in response to cold or stress), joint pain, and difficulty swallowing.
Blood Tests: Clinicians use several blood tests to support the diagnosis. Antinuclear antibodies (ANA) are commonly positive in scleroderma patients, although not specific. More specific diagnostic tests include the determination of antibodies against centromere antibodies (CENP), often associated with limited cutaneous scleroderma and anti-Scl-70 (topoisomerase I) antibodies, which are linked to diffuse systemic sclerosis and more severe disease2.
Other tests may include, but are not limited to, imaging to evaluate organ involvement, pulmonary function to detect early lung involvement, and skin biopsy to confirm the diagnosis.
Early recognition and diagnosis of scleroderma through these tests allow for timely treatment, improving patient outcomes and quality of life.
Related products for the scleroderma diagnostics
At Medipan & GA Generic Assays, we support specialized laboratories in addressing the complex diagnostic challenges of scleroderma. As no single technology can fully capture the diverse nature of autoimmune diseases, a multi-method approach is essential.
Indirect Immuno Fluorescence (IFA)
Our portfolio includes IFA tests based on HEp-2 cells, suitable for both visual interpretation as well as for automated imaging and pattern recognition with the akiron® NEO. They deliver an ideal screening method thanks to its high sensitivity.
Immunoblot
To detect specific autoantibodies, we offer a range of immunoblot tests that identify reactivity to purified antigens. These tests support both manual and automated processing with the DotDiver2.0.
A dedicated diagnostic kit, REF 5069 DotDiver Scleroderma 10, includes the following antigens: Scl-70, CENP-A, CENP-B, PM/Scl-100, PM/Scl-75, Ku, RNA Polymerase III, RNP (68kD/A/C), Fibrillarin, and Th/To.
Additional ANA/ENA profiles are also available to aid the diagnosis of scleroderma and differentiate it from other autoimmune diseases or overlapping syndromes.
CytoBead® Technology
ANA tests based on CytoBead® Technology combine the high sensitivity of HEp-2-based IFA with the specificity of a multiplex assay targeting 8 purified antigens. CytoBead® ANA tests offer a powerful, simultanusly screening and confirmatory approach to autoantibody detection. This reduces hands-on time and saves lab resources by consolidating multiple analyses into a single, efficient workflow.
Enzyme-Linked Immunosorbent Assay (ELISA)
For labs using established and scalable ELISA solutions, we offer semi-quantitative (REF 4010 ANAscreen) and quantitative (REF 5032 ANAscreen quant) kits for the simultaneous detection of IgG antibodies against nuclear and cytoplasmic antigens. We also provide REF 4012 ANApro, a test for the separate detection of IgG antibodies against 8 specific nuclear and cytoplasmic target antigenes.