Diagnostic Automation Rubella IgG Elisa Test Kit is intended for use in the detection of IgG antibody to the rubella virus. Rubella IgG is an accurate and sensitive method to detect Rubella antibody IgG isotype.





Material Provided with Rubella IgG ELISA Kit:
1. Microwell strips:Rubella antigen coated wells
2. Rubella IgG EIA Kit Enzyme conjugate
3. Negative Calibrator: 0 IU/ml
4. Cut-off Calibrator:15 IU/ml Rubella G Index = 1.0
5. Positive Calibrator:30 IU/ml
6. Positive Calibrator:100 IU/ml
7. Rubella IgG EIA Kit Negative Control
8. Rubella IgG EIA Kit Positive Control
9. Washing concentrate 20x
10.Rubella EIA Test Sample diluent
11.TMB Chromogenic Substrate
12.Stop solution:

Materials & Instrumentations required, not included:
1. EIA Kit Microplate Reader at 450
2. EIA Kit Microplate Washer





Rubella IgG ELISA Test Kit Background Information
Rubella also known as German measles is caused by Rubella virus which belongs to the Togavirus family. Togavirus is an enveloped virus with a single-stranded RNA genome. Generally rubella is considered a mild adolescence disease. However a maternal infection could be transmitted through the placenta to the fetus, causing congenital rubella or congenital rubella Syndrome in newborn. Congenital rubella may result in chronic cardiac disease, growth retardation, hepatosplenomegaly, auditory defects, blindness, cerebral malformations and other severe anomalies. The first trimester defect is assoiated with the highest risk of defects in organogenesis. Children born asymptomatic may develop these abnormalities later in life. To reduce risk of such severe complications, accurate serological methods must be performed to determine the serologic status of childbearing aged women. The Rubella antibody status of pregnant women are commonly determined at the first prenatal visit. Those without antibodies are monitored through early pregnancy for seroconversion. The antibodies present to Rubella may be of IgA, IgG, and IgM. Rubella IgG elisa test provides an accurate and sensitive method to detect Rubella IgG antibody.





Rubella IgG ELISA Test Principle
Purified rubella antigen is coated on the surface of microwells. Diluted patient serum is added to wells and the rubella IgG specific antibody, if present, binds to the antigen. All unbound materials are washed away. After adding enzyme conjugate, it binds to the antibody-antigen complex. Excess enzyme conjugate is washed off and TMB Chromogenic substrate is added. 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 calibrator and controls.




Rubella IgG Elisa Test Results Interpretation
Negative: Rubella G Index less than 0.90 are negative for IgG antibody to rubella virus
Positive: Rubella G Index of 1.00 or greater are positive for IgG antibody to rubella virus




Rubella IgG Elisa Test Performance Characteristics
The precision of the assay was evaluated by testing three different sera eight replicates on 3 days. The intra-assay and inter-assay C.V. are:
Intra-assay: Negative 8.5% Low positive 7.4% Positive 5.2%
Inter-assay: Negative 9.6% Low positive 8.2% Positive 6.5%




Precautions on Rubella IgG Elisa ELISA (EIA) Kit
The calibrator and controls contain human source components which have been tested and found nonreactive for hepatitis B surface antigen as well as HIV antibody with FDA licensed reagents. However, as there is no test method that can offer complete assurance that HIV, Hepatitis B virus or other infectious agents are absent, these reagents should be handled at the Biosafety Level 2, is recommended.




Rubella IgG ELISA Related Kits:

Rubella IgA ELISA Kit

http://www.rapidtest.com/index.php?i=Rubella-IgA-ELISA-kit&id=107&cat=16

Rubella IgM ELISA Kit

http://www.rapidtest.com/index.php?i=Rubella-IgM-ELISA-kit&id=106&cat=16


Rubella Chemiluminescence Immuno Assay (CLIA) Kits:

Rubella IgG CLIA kit

http://www.rapidtest.com/index.php?i=Rubella-IgG-CLIA-kits---(Chemiluminescence-Immuno-Assay)&id=550&cat=41


Rubella IgM CLIA kit

http://www.rapidtest.com/index.php?i=Rubella-IgM-CLIA-kits---(Chemiluminescence-Immuno-Assay)&id=551&cat=41


Diagnostic Automation Inc. also provides other Test Kits:

http://www.rapidtest.com/index.php?product=Rapid-Tests


For more information about ELISA Kits, Rapid Tests, CLIA tests, or IFA Tests, please contact our Customer Service Representatives at 818-591-3030.