Enzyme ImmunoAssay (ELISA) for the quantitative/qualitative determination of IgG antibodies to Rubella Virus in human plasma and sera.

Regulatery Status: CE
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Product Catalog No: RUBG Pack Size: 96 Wells

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Summary

Rubella is a small spherical enveloped virus, 55-60nm in diameter, and is the only member of the genus Rubivirus of the family Togaviridiae.

The virus contains a single positive stranded 42s RNA molecule and only one serotype is known. The virus encodes for at least three envelope glycoproteins, E1, E2a, E2b; a nucleocapsidassociated protein, C; and two nonstructural proteins. The detection of Rubella-specific IgG and IgM antibodies is very important for the serological diagnosis of both congenital and primary postnatal rubella infections as they can lead to severe birth defects.

The absence of Rubella-specific IgG antibodies in sera, characteristically of long-term duration after primary infections, in presence of virus-specific IgM, is indicative for the risk of defects in newborn infants.

Highly specific Rubella IgG assays provide the clinician with a helpful and reliable test for the monitoring of these risks in pregnancy and for the monitoring of the immunological response upon vaccination.

Test Principle

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.

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    References
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