INTENDED USEAnti-dsDNA is an indirect solid phase enzyme immunoassay (ELISA) for the quantitative measurement of IgG classautoantibodies against double-stranded DNA in human serum or plasma. The assay is intended as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE). For In Vitro Diagnostic Use.SUMMARY OF THE TESTAutoimmune diseases are characterized by the occurence of antibodies against one’s own antigenic structures, also known as autoantibodies. Presence of autoantibodies to native desoxyribonucleic acids (n-DNA, dsDNA, double-stranded DNA) is typical for the clinical picture of SLE. Antibodies against dsDNA belong to the group of Anti Nuclear Antibodies (ANA), which are directed against various structures of the nucleus of the cell. They appear in a variety of rheumatoid diseases. Antibodies to dsDNA are found during the active phases of SLE. Diagnostic sensitivity of the anti-dsDNA determination in cases of SLE is approximately 91 % combined with a diagnostic specificity of nearly 96 percent. SLE like diseases are caused by some drugs. For differential diagnosis of drug-induced SLE the determination of anti-dsDNA is a valuable diagnostic tool. PRINCIPLE OF THE TESTHuman recombinant double-stranded DNA (dsDNA) is bound to microwells. Antibodies to this antigen bind to the respective antigen. Washing of the microwells removes unspecific serum/plasma components. Horseradish peroxidase (HRP) conjugated anti-human IgG immunologically detects the bound patient antibodies forming a conjugate/antibody/antigen complex. Washing of the microwells removes unbound conjugate. An enzyme substrate in the presence of bound conjugate hydrolyzes to form a blue color. The addition of an acid stops the reaction forming a yellow color in the test well which is measured photometrically at 450 nm. The amount of color is directly proportional to the concentration of IgG antibodies present in the original sample. Refer to Product Package Insert.
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to double stranded DNA (anti-dsDNA) in a clinical specimen, using an enzyme immunoassay (EIA) method.
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