5045 – DotDiver PmScl 12

Intended Purpose

The DotDiver PmScl 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-54, Mi-2, MDA-5, TIF1-γ, Ku, PM-Scl 100, Scl-70 and SSA/Ro52) in human serum. The DotDiver PmScl 12 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.

Product Specifications

Title DotDiver PmScl 12
Product code 5045
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 Jo-1, PL-7, PL-12, EJ, SRP-54, Mi-2, MDA-5, TIF1-γ, Ku, PM-Scl 100, Scl-70 and SSA/Ro52
Total incubation time 64 min.
Sample volume 10 µL serum
No. of determinations 24 x 12

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.