5016 – DotDiver ANA
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.
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.
|Indication||Systemic autoimmune diseases|
|Description||Dot immunoassay for the qualitative determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum|
|Format||Test strips coated with Sm, Sm/RNP, SS-A, SS-B, Jo-1, Scl-70, PM-Scl-100 and CENP-A/B|
|Total incubation time||64 min.|
|Sample volume||10 µL serum|
|No. of determinations||24 x 8|