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Rubella IgG ELISA test 96wells/kit, high accuracy, Elisa Sandwich method, for quantitative measurement
Product Name: The Rubella IgG ELISA test
The Rubella IgG ELISA Test System is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. The test system is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for in vitro diagnostic use.
Rubella is a mild, contagious viral infection that occurs primarily in children and young adults .Rubella is characterized by an erythematous maculopapular rash that lasts two or three days. However, greater than 50% of rubella infections are not clinically apparent. Other symptoms of rubella may include low grade fever, mild upper respiratory symptoms, and suboccipital lymphadenopathy. Transient arthralgia and arthritis are common symptoms in young adults but more severe complications such as encephalitis or thrombocytopenic purpura are very uncommon. Although rubella infection in a child or adult is usually benign and self-limiting, infection of the fetus during the first trimester may cause spontaneous abortion, stillbirth or congenital birth defects. Infants infected in utero may be born with obvious birth defects or, more commonly, appear normal and either remain normal or develop later complications. Congenital rubella syndrome has long been recognized and is characterized by congenital heart disease, cataracts, neurosensory deafness, mental retardation, and intrauterine growth retardation. Following an epidemic of rubella in 1964, other clinical manifestations of congenital rubella were recognized and include neonatal thrombocytopenic purpura, hepatitis, bone lesions and meningoencephalitis. Also, diabetes mellitus and progressive rubella panencephalitis are late-emerging manifestations of congenital rubella infection that have recently been recognized. Rubella is endemic worldwide. In countries without vaccination programs, 10 - 25% of women of childbearing age are seronegative and susceptible to infection. Extensive vaccination programs in the United States and the United Kingdom have greatly reduced the incidence of congenital rubella syndrome. Fewer than ten cases per year are now reported in the United States.
The presence of circulating maternal antibody indicates immunity to rubella and virtually excludes the possibility of transmission of rubella to the fetus. If rubella is acquired during pregnancy, particularly during the first trimester, the fetus may be at risk of becoming infected. Acute rubella infection can be confirmed by simultaneously testing paired acute and convalescent sera and looking for seroconversion or a fourfold rise in titer, or by the presence of rubella specific IgM. The presence of rubella specific IgM in the neonate or the persistence of a high titer of IgG antibody for longer than expected for passively acquired antibody (6 months) confirms a diagnosis of congenital rubella.
Hemagglutination inhibition (HAI), the first widely used technique for detection of rubella antibody, has been the reference standard against which newer methods are measured. However, the HAI test is labor intensive and difficult to perform since serum samples must be pretreated to remove b-lipoprotein. The ELISA (enzymelinked immunosorbent assay) has been shown to be a sensitive and reliable procedure for detection of antibodies to rubella. ELISA is less cumbersome than HAI and more applicable to screening large numbers of samples, since determinations are made on a single serum dilution which does not require pretreatment. Also, ELISA results are based on an objective absorbency reading which can be correlated with HAI titers.
The ELISA method is based upon the reaction of antibodies in the sample tested with the antigen adsorbed on the polystyrene surface. Unbound immunoglobulins are washed off. An enzyme-labelled anti-human globulin binds the antigen-antibody complex in a second step. After a new washing step, bound conjugate is developed with the aid of a substrate solution (TMB) to render a blue coloured soluble product which turns into yellow after adding the acid stopping solution.
VALIDATION PROTOCOL FOR USERS:
Positive, negative and cut off controls must be run with each test run. It allows the validation of the assay and kit.
Optical densities (O.D.) must fall in the following ranges. Otherwise, the test is invalid and must be repeated.
|CUT OFF CONTROL||<0.7 x(O.D. POSITIVE CONTROL)|
|>1.5 x(O.D. NEGATIVE CONTROL)|
INTERPRETATION OF RESULTS:
Calculate the mean O.D. for cut off serum.
Antibody index=(sample O.D./ cut off serum mean O.D.) x 10
Samples with equivocal results must be retested and/or a new sample obtained for confirmation.
|ORIENT NEW LIFE MEDICAL CO., LTD.|
|Email:||Jerry @ newlifebiotest .com|
Contact Person: Jerry Meng