The device SM.CE is an Enzyme ImmunoAssay (ELISA) intended to be used for the quantitative determination of IgG autoantibodies against Sm autoantigens in human plasma and sera.

For in vitro diagnostic use only.

Microplates are coated with a preparation of purified Sm antigen. In the 1st incubation, the solid phase is treated with diluted samples and anti-Sm 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-Sm 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-Sm 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.