5016 – DotDiver ANA

Intended Purpose

The DotDiver ANA is a qualitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (Sm, Sm/RNP, SS-A, SS-B, Jo-1, Scl-70, PM-Scl-100, CENP-A/B) in human serum. The DotDiver ANA 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) or systemic scleroderma is an autoimmune disease of connective tissue characterized by slowly progressive fibrosis leading to sclerosis.

Scl-70 autoantibodies are pathognomonic for PSS patients. Polymyositis and dermatomyositis are idiopathic inflammatory muscle disorders with an unknown etiology, however, autoantibodies to t-RNA transferases like Jo-1, PL-7, and PL-12 are found in myositis patients. Antibodies to SRP are also specific markers for Polymyositis. Mi-2 autoantibodies are detected almost exclusively in patients with dermatomyositis. Patients tested positive for Mi-2 have a relatively mild clinical course.