5069 – DotDiver Scleroderma 10

Intended Use

The DotDiver Scleroderma 10 is a qualitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (Scl-70, CENP-A, CENP-B, PM/Scl-100, PM/Scl-75, Ku, RNA Polymerase III, RNP (68kD/A/C), Fibrillarin and Th/To) in human serum. The DotDiver Scleroderma 10 is intended as an aid in the diagnosis of scleroderma 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. CREST syndrome, a limited form of scleroderma, is characterized by autoantibodies to centromere proteins (CENP). In indirect immunofluorescence assay scleroderma patients often show positive staining of nucleoli, caused by antibodies e.g. to fibrillarin, PM/Scl or RNA polymerases. Most of these autoantibodies are highly specific for scleroderma.

Product Specifications

Title DotDiver Scleroderma 10
Product code 5069
Indication Scleroderma diseases
Description Dot immunoassay for the qualitative determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum
Format Test strips coated with Scl-70, CENP-A, CENP-B, PM/Scl-100, PM/Scl-75, Ku, RNA Polymerase III, RNP (68kD/A/C), Fibrillarin and Th/To
Total incubation time 64 min.
Sample volume 10 µL serum
No. of determinations 24 x 10

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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.