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Pregnancy Rapid tests

Rubella IgM ELISA Test

Name

Rubella IgM ELISA kit

Full name

Human Rubella IgM ELISA Test kit

Category Name TORCH Panel
Test 96
Method ELISA method: Enzyme Linked Immunosorbent Assay
Principle ELISA principle - Indirect; Antigen Coated Plate
Detection Range Qualitative elisa assay- Positive, Negative and Cut-off
Sample 5ul
Specificity 99%
Sensitivity 100%
Total Time 90 min
Shelf Life 12 Months from the manufacturing date

Item #:                    1302-11   Quantity:               

Rubella IgM ELISA Test

Rubella IgM 1302-11 MSDS(02-20-2014).pdf

Rubella IgM ELISA Test

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Rubella IgM ELISA Test description:




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




Material Provided with Rubella IgM ELISA Kit:
1. Rubella IgM EIA Kit Microwell Strips: purified Rubella antigen coated wells
2. Absorbent Solution, 22 ml
3. Enzyme Conjugate Rubella IgM EIA, 12 ml
4. Calibrator Rubella IgM EIA, 150 ul
5. Washing Concentrate 20x, 50 ml
6. Rubella IgM Elisa Kit Negative Control, 150 ul
7. Rubella IgM Elisa Kit Positive Control, 150 ul
8. TMB Chromogenic Substrate, 12 ml
9. Rubella IgM EIA Stop Solution, 12 ml

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





Rubella IgM 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 IgM, IgA, and IgG. The Rubella test kit provides an accurate and sensitive method to detect Rubella IgM antibody.




Rubella IgM ELISA Test Principle
Purified rubella antigen is coated on the surface of microwells. Diluted patient serum is added to wells and the rubella IgM 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 IgM specific antibody in the sample. The results are read by a microwell reader compared in a parallel manner with calibrator and controls.




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




Rubella IgM 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 IgM 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 IgM ELISA Related Kits:

Rubella IgA ELISA Kit

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


Rubella IgG ELISA Kit

http://www.rapidtest.com/index.php?i=Rubella-IgG-ELISA-Test&id=105&cat=16


Rubella Chemiluminescence Immuno Assay (CLIA) Kits:


Rubella IgG CLIA kits

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


Rubella IgG CLIA kits

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.


Product Note:

The Rubella IgM Elisa kit belongs to Infectious diseases products.