Description
RUBG.CE: RUB IgG – ELISA
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.
RUBM.CE: RUB IgM – ELISA
Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Rubella Virus in human plasma and sera with the “capture” system. The devise is intended for the follow-up of Rubella Virus infected patients and for the monitoring of risk of neonatal defects due to Rubella Virus infection during pregnancy.
For “in vitro” diagnostic use only.
The assay is based on the principle of “IgM capture” where IgM class antibodies in the sample are first captured by the solid phase coated with anti hIgM antibody.
After washing out all the other components of the sample and in particular IgG antibodies, the specific IgM captured on the solid phase are detected by the addition of a purified preparation of inactivated Rubella Virus, labeled with a specific monoclonal antibody conjugated with peroxidase (HRP).
After incubation, microwells are washed to remove unbound conjugate and then the chromogen/substrate is added.
In the presence of bound conjugate the colorless substrate is hydrolyzed to a colored end-product, whose optical density may be detected and is proportional to the amount of IgM antibodies to Rubella Virus present in the sample. A system is described how to control whether the positivity shown by a sample is true or not (Confirmation Test), helpful for the clinician to make a correct interpretation of results.
