Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Rubella Virus in human plasma and sera. For “in vitro” diagnostic use only.
Microplates are coated with native Rubella Virus, highly purified by sucrose gradient centrifugation and inactivated. The solid phase is first treated with the diluted sample and IgG to Rubella Virus are captured, if present, by the antigens.
After washing out all the other components of the sample, in the 2nd incubation bound anti Rubella IgG are detected by the addition of polyclonal specific anti hIgG antibodies, labelled 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 Rubella Virus IgG antibodies present in the sample.
A Calibration Curve, calibrated against the 1st W.H.O international standard for anti-Rubella immunoglobulin code RUBI-1-94, makes possible a quantitative determination of the IgG antibody in the patient.