The device SCL70.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the quantitative determination of IgG autoantibodies against Scl-70 autoantigens in human plasma and sera.
For in vitro diagnostic use only.
Microplates are coated with a preparation of recombinant Scl-70 antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti-SCL70 IgG are captured, if present, by the solid phase.After washing out all the other components of the sample, in the 2nd incubation bound anti-SCL70 are detected by the addition of anti hIgG antibody, labeled with peroxidase (HRP).
The enzyme captured on the solid phase, acting on the substrate/chromogen mixture, generates an optical signal that is proportional to the amount of anti-SCL70 IgG antibodies present in the sample. IgG in the sample may be quantitated by means of a standard curve calibrated in arbitrary units per milliliter (arbU/ml) as no international standard is available.