5045 – DotDiver PmScl 12

Highlights

• Qualitative dot immunoassay for IgG antibodies against nuclear and cytoplasmic antigens (Jo-1, PL-7, PL-12, EJ, SRP-54, Mi-2, MDA-5, TIF1-γ, Ku, PM-Scl 100, Scl-70, SSA/Ro52)
• Supports diagnosis of systemic autoimmune diseases, including systemic sclerosis, polymyositis, and dermatomyositis
• Enables differentiation of autoantibody profiles for classification and prognosis of myositis and scleroderma
• Simultaneous detection of multiple autoantibodies on a single test strip
• Designed for semi-automated use with the DotDiver instrument
• Simultaneous analysis of multiple autoantibodies on one test strip
• CE marked

Intended Use

The DotDiver PmScl 12 is a qualitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (Jo-1, PL-7, PL-12, EJ, SRP-54, Mi-2, MDA-5, TIF1-γ, Ku, PM-Scl 100, Scl-70 and SSA/Ro52) in human serum. The DotDiver PmScl 12 is intended as an aid in the diagnosis of systemic autoimmune diseases in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Progressive Systemic Sclerosis (PSS)

Progressive systemic sclerosis, also called systemic scleroderma, is a chronic autoimmune disease in which connective tissue gradually develops fibrosis. This process causes skin thickening and can affect internal organs. Scl-70 autoantibodies specifically indicate PSS and correlate with diffuse skin involvement and a higher risk of pulmonary fibrosis. Clinicians may also detect other autoantibodies, such as PM-Scl 100 and Ku, in patients who show overlap syndromes between scleroderma and myositis.

Polymyositis and Dermatomyositis

Polymyositis and dermatomyositis are idiopathic inflammatory muscle diseases that cause progressive muscle weakness, elevated muscle enzymes, abnormal electromyographic findings, and characteristic skin changes in dermatomyositis. Myositis patients often produce autoantibodies targeting t-RNA synthetases, including Jo-1, PL-7, and PL-12, which help classify the disease. SRP antibodies strongly indicate polymyositis and often appear in patients with severe and rapidly progressive muscle involvement. Patients with dermatomyositis frequently develop Mi-2 autoantibodies, which typically associate with a milder disease course and better response to therapy. Clinicians also detect antibodies against MDA-5 and TIF1-γ in dermatomyositis, which may link to clinical signs such as skin ulceration or an increased risk of malignancy.

Clinical Relevance of Autoantibody Detection

Detecting these autoantibodies has clinical relevance not only for diagnosis but also for prognostic assessment. It also aids in patient stratification and in monitoring disease progression. The DotDiver PmScl 12 test allows simultaneous analysis of multiple disease-relevant autoantibodies on a single strip. This provides comprehensive serological profiles that help differentiate overlapping clinical entities. The test is suitable for specialized laboratories and can be integrated into a broader diagnostic workflow for systemic autoimmune diseases. It facilitates informed clinical decision-making and supports tailored patient management.