Rubella IgM ELISA

The DRG Rubella Virus IgM Enzyme Immunoassay Kit provides materials for the quantitative and qualitative determination of IgM-class antibodies to Rubella Virus in human serum and plasma. This assay is intended for in vitro diagnostic use only.Rubella is an enveloped RNA virus belonging to the togavirus. It has a spherical shape measuring about 50-70 nm in diameter. There appears to be only one antigenic type, and no cross-reactivity with alphavirus or other members of the togavirus group has been found. Rubella viruses are pathogens of the respiratory tract and transmitted mainly by droplet infection. Rubella is a worldwide common contagious disease with mild constitutional symptoms and a generalized rash. In childhood, it is an inconsequential illness, but when it occurs during pregnancy, there is a significant risk of severe damage to the fetus. The risk of congenital rubella depends primarily on the month of pregnancy in which infection is acquired: overall, app. 16% of infants have major defects at birth following maternal rubella in the first 3 months of pregnancy. Congenital rubella infection may lead to a syndrome with single or multiple organ involvements, known as embryopathia rubeolosa. In some cases infection is inapparent but results in consequential damages as eye defects,deafness, growth retardation, and others. Naturally acquired immunity usually is long-lasting, but reinfection is possible due to decreasing levels of circulating antibodies. For immunization a vaccine containing live virus is used. Rubella Infection may be identified by detection of virus by PCR (prenatal), Hemagglutination inhibition (HAI), Haemolysis-in-gel test (HiG), detection of antibodies by EIA, ELISA. Measurement of antibodies in the serum is important for the determination of the immune status. Even a previous infection though rather overt may not yield a long-lasting immunity, but may result in an antibody titer too low to prevent reinfection. Especially the screening of adolescents and young women should be a mandatory routine in prenatal care. The DRG Rubella Virus IgM ELISA Kit is a solid phase enzyme-linked immunosorbent assay (ELISA). Patient samples are diluted with Sample Diluent and additionally incubated with IgG-RF-Sorbent, to eliminate competitive inhibition from specific IgG and to remove rheumatoid factors. This pretreatment avoids false negative or false positive results.Microtiter wells as a solid phase are coated with inactivated K1S grade Rubella Virus antigen (strain HPV-77). Diluted patient specimens and ready-for-use controls are pipetted into these wells. During incubation Rubella Virus-specific antibodies of positive specimens and controls are bound to the immobilized antigens. After a washing step to remove unbound sample and control material horseradish peroxidase conjugated anti-human IgM antibodies are dispensed into the wells. During a second incubation this anti-IgM conjugate binds specifically to IgM antibodies resulting in the formation of enzyme-linked immune complexes. After a second washing step to remove unbound conjugate the immune complexes formed (in case of positive results) are detected by incubation with TMB substrate and development of a blue color. The blue color turns into yellow by stopping the enzymatic indicator reaction with sulfuric acid. The intensity of this color is directly proportional to the amount of Rubella Virus-specific IgM antibody in the patient specimen. Absorbance at 450 nm is read using an ELISA microtiter plate reader.