The DIASTAT® anti-dsDNA test is a quantitative/qualitative ELISA for the detection of IgG and IgM autoantibodies specific for double-stranded DNA (dsDNA) in human serum or plasma.
It is intended to aid in the diagnosis of systemic lupus erythematosus, and to monitor dsDNA antibody levels during treatment and remission. Autoantibody levels represent one parameter in a multicriterion diagnostic process and the detection of dsDNA autoantibodies by the ELISA technique is a simple, sensitive and reproducible method that can be standardised by reference to the World Health Organisation anti-dsDNA standard, Wo/80.
Antibodies against dsDNA are characteristic for systemic lupus erythematosus (SLE) and are one of the criteria for disease classification by the American College of Rheumatology. The presence of these antibodies has high diagnostic specificity for SLE (90%) and can be used to monitor the treatment effect in patients.
|Assay target||dsDNA antibodies|
|Read-out of results||Qualitative, Quantitative,|
|Detection system||ALP/PMP read at 550 nm|
|Regulatory status||IVD, CE labeled, 510(k) FDA|
All reagents in the kit are ready for use except wash buffer concentrate, sample diluent concentrate, positive and negative control. All reagents should be stored at 2-8° C.
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