5017 – DotDiver PmScl

Highlights

• Detection of IgG antibodies against nuclear and cytoplasmic antigens (Jo-1, PL-7, PL-12, SRP, Mi-2, Ku, PM-Scl 100, Scl-70)
• Qualitative dot immunoassay for human serum
• Supports diagnosis of systemic autoimmune diseases including polymyositis, dermatomyositis, and systemic sclerosis
• High diagnostic relevance for overlap syndromes and organ involvement
• Ready-to-use test strips and reagents
• Reliable and reproducible results for routine laboratory testing
• Ready-to-use test strips and reagents
• Suitable for monitoring disease progression and autoantibody profiles
• CE marked

Intended Use

The DotDiver PmScl is a qualitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (Jo-1, PL-7, PL-12, SRP, Mi-2, Ku, PM/Scl-100 and Scl-70) in human serum. The DotDiver PmScl 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 automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Progressive systemic sclerosis (PSS), also known as systemic scleroderma, is an autoimmune connective tissue disorder that causes slow, progressive fibrosis and leads to tissue sclerosis. Scl-70 autoantibodies are highly specific markers for PSS and help in distinguishing patients with diffuse disease involvement.

Polymyositis and dermatomyositis are idiopathic inflammatory muscle disorders. They cause progressive muscle weakness, atrophy of peripheral muscles, and biochemical as well as electromyographic signs of muscle injury. Autoantibodies targeting t-RNA synthetases, such as Jo-1, PL-7, and PL-12, are commonly present in myositis patients. These antibodies serve as disease-specific markers. Antibodies to the signal recognition particle (SRP) mainly occur in polymyositis. Mi-2 autoantibodies occur almost exclusively in dermatomyositis. Patients positive for Mi-2 generally have a milder clinical course. Those with SRP or other markers may experience more severe disease manifestations.

Detection of these autoantibodies aids in disease classification, supports early diagnosis, and allows for monitoring of clinical progression and therapeutic response, providing valuable information for personalized patient management.