5093 – DotDiver Myositis 12

Intended Purpose

The DotDiver Myositis 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, Mi-2, MDA-5, TIF1-γ, SSA/Ro52kD, SAE1, SAE2 and NXP-2) in human serum. The DotDiver Myositis 12 is intended as an aid in the diagnosis of autoimmune myositis 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

Polymyositis, an idiopathic inflammatory muscle disorder with unclear etiology, is characterized by muscle weakness, atrophy of peripheral muscles, biochemical and electromyographic signs of muscle damage, with skin alterations. Autoantibodies to t-RNA synthetases like Jo-1, PL-7, PL-12 and EJ are found in a large group of myositis patients. Other specific antibodies associated with polymyositis, including dermatomyositis are SRP, Mi-2, TIF1-γ.