5093 – DotDiver Myositis 12

Highlights

• Detection of IgG antibodies against 12 nuclear and cytoplasmic antigens relevant for autoimmune myositis
• Supports the diagnosis of polymyositis, dermatomyositis, and associated autoimmune disorders
• High diagnostic relevance for distinguishing specific myositis subtypes and disease severity
• Ready-to-use test strips and reagents for efficient laboratory workflow
• Enables monitoring of autoantibody profiles and progression of autoimmune myositis
• Automated
• CE marked

Intended Use

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 and dermatomyositis are idiopathic inflammatory muscle disorders that cause progressive muscle weakness, atrophy of peripheral muscles, biochemical and electromyographic evidence of muscle damage, and distinctive skin manifestations. Autoantibodies directed against t-RNA synthetases, such as Jo-1, PL-7, PL-12, and EJ, are highly specific markers for myositis patients, helping to differentiate disease subtypes. Antibodies to the signal recognition particle (SRP) are associated with polymyositis and may indicate a more severe disease course.

Mi-2 autoantibodies primarily occur in dermatomyositis patients and associate with a relatively mild disease course. TIF1-γ autoantibodies correspond to more aggressive skin involvement and a higher risk of cancer-associated dermatomyositis in adults. MDA5 antibodies specifically mark amyopathic dermatomyositis with interstitial lung disease. NXP-2 antibodies appear in severe dermatomyositis cases in both juvenile and adult patients, often linked to calcinosis, muscle contractures, and occasionally malignancy. SAE1 and SAE2 antibodies also occur in dermatomyositis, but they rarely cause systemic disease.

The DotDiver Myositis 12 assay allows simultaneous detection of multiple myositis-specific and myositis-associated autoantibodies, enabling comprehensive serological profiling. Early identification of these antibodies aids clinicians in the diagnosis, subclassification, and management of myositis patients, as well as in monitoring disease progression and potential extra-muscular involvement, including lung and skin manifestations.