4049 – PmScl^plus Dot

Highlights

• Use of recombinant and purified nuclear and cytoplasmic antigens
• Qualitative dot immunoassay for the detection of IgG antibodies in human serum
• Use as an aid in the diagnosis of systemic autoimmune diseases, including PSS, polymyositis, and dermatomyositis
• Detection of multiple autoantibodies on a single test strip, enabling rapid assessment of antibody patterns
• Positive and negative controls included for reliable interpretation
• Manual test for professional in vitro diagnostic use
• CE marked

Intended Use

PmSclplus Dot is a qualitative dot immunoassay for detecting IgG antibodies against nuclear and cytoplasmic antigens in human serum, including Jo-1, PL-7, PL-12, SRP, Mi-2, Ku, PM-Scl 100, and Scl-70. The assay detects multiple autoantibodies on a single test strip, providing a comprehensive overview of a patient’s autoantibody profile.

This test aids in the diagnosis of systemic autoimmune diseases such as progressive systemic sclerosis (PSS), polymyositis, dermatomyositis, and overlap syndromes when used alongside clinical and laboratory findings. By enabling rapid and reliable detection of disease-specific autoantibodies, it supports clinicians in making informed diagnostic and therapeutic decisions. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Progressive systemic sclerosis (PSS), also known as systemic scleroderma, is an autoimmune connective tissue disease characterized by slowly progressive fibrosis and sclerosis. Patients often develop skin thickening and hardening, and internal organs such as the heart, lungs, and kidneys can also be affected. Autoantibodies to Scl-70 are highly specific and considered pathognomonic for PSS.

Polymyositis and dermatomyositis are idiopathic inflammatory muscle disorders with an unknown etiology, characterized by muscle weakness, atrophy, and biochemical or electromyographic evidence of muscle damage. In these conditions, clinicians frequently detect autoantibodies to t-RNA synthetases, including Jo-1, PL-7, and PL-12, in patients with myositis. SRP antibodies indicate polymyositis, while Mi-2 autoantibodies occur mainly in dermatomyositis patients, who typically experience a milder clinical course.

Overlap syndromes may present features of both PSS and myositis, and patients with overlap frequently test positive for Ku or PM-Scl autoantibodies. The detection of these autoantibodies provides essential diagnostic and prognostic information, enabling better disease characterization and guiding patient management.