Introduction:Rubella IgG ELISA is intended for use in evaluating serologic status to the rubella virus infection. It is also used to evaluate paired sera for the presence of a significant increase in specific Rubella IgG as indication of a recent or current rubella virus infection.
Introduction:Rubella is a herpes virus. Generally rubella is considered a mild adolescent disease. However, a maternal infection can be transmitted through the placenta to the fetus, causing congenital rubella. Congenital rubella may result in chronic cardiac disease, growth retardation hepatosplenomegaly, malformations and other severe anomalies. Children born asymptomatic may develop these abnormalities later in life. To reduce the risk of such severe complications, accurate serological methods must be performed to determine the serologic status of childbearing-aged women. The presence of rubella-specific IgG in the bloodstream attests immunity to rubella. A woman tested to be non-immune can be educated on infection and differentiate rubella from other exanthematous diseases. Expecting women with current rubella infection should be counseled on the consequences of congenital infection.
Test Principle:Purified Rubella antigen is coated on the surface of microwells. Diluted serum is added to the wells, and the Rubella IgG-specific antibody, if present, binds to the antigen during incubation. After washing the wells to remove unbound sample, antibody to human IgG conjugated with horseradish peroxidase (HRP) is added and incubated at 37°C for 30 minutes. Unbound conjugate is removed by a subsequent washing step. A solution of TMB Reagent is then added to the microwells. The enzyme conjugate catalytic reaction is stopped at a specific time. The intensity of the color generated is proportional to the amount of IgG-specific antibody in the sample. The results are read by a microwell reader compared in a parallel manner with calibrators and controls.
Kit Components:Antigen-Coated Wells (1 plate, 96 wells, 12x8 strips), Microtiter Wells coated with purified Rubella antigenEnzyme Conjugate Reagent (12ml), Contains goat anti-human IgG conjugated to horseradish peroxidase with preservativesSample Diluent (22ml), Contains phosphate buffer with preservativesNegative Calibrator: 0 IU/ml (150ul/vial), Contains Rubella IgG negative serum with preservativesCut-off Calibrator: 15 IU/ml (150ul/vial), Contains Rubella IgG positive serum with preservativesPositive Calibrator: 30 IU/ml (150ul/vial), Contains Rubella IgG positive serum with preservativesPositive Calibrator: 100 IU/ml (150ul/vial), Contains Rubella IgG positive serum with preservativesNegative Control (150ul/vial), Contains Rubella IgG negative serum with preservatives; Range stated on the label
Positive Control (150ul/vial), Contains Rubella IgG positive serum with preservatives; Range stated on the label
Storage and Stability:Store all components at 4°C. Stable for at least 6 months. For maximum recovery of product, centrifuge the original vial prior to removing the cap.
