Description:1. Intended Use The GenWay EBV EBNA-1 IgM Antibody ELISA Test Kit has been designed for the the detection and the quantitative determination of specific IgM antibodies against EBV EBNA-1 in serum and plasma. Further applications in other body fluids are possible and can be requested from the Technical Service of GenWay. This assay is intended for research use only.  2. General Information In 1961 an infectious disease was identified in Uganda, which was correlated with the appearance of a defined type of tumor with children. The illness, which is found predominantly in Africa and Papua-New Guinea, was named Burkitt lymphoma from its discoverer. The Epstein Barr virus is made responsible for a variety of diseases like infectious mononucleosis, Burkitt lymphoma, as well as nasopharyngeal carcinoma. In addition, a role  of the virus is discussed in connection with Hodgkin´s disease. Especially with teenagers there appears a glandular fever syndrome, which is called „kissing disease“. Diseases which are caused by the Epstein Barr virus are found mainly in persons with reduced immunity. For example, the  virus is associated with a lymphoproliferative disease which occurs after transplantation. The immune system of such individuals is usually impaired by drug therapy. Also in immune-deficient AIDS affected individuals, there appears frequently a state where cells at the rim of the tongue are infected (oral hairy leukoplakia). Infected persons keep the Epstein-Barr virus forever in their body, they are however mostly not ill. In the developing countries practically all the people are infected, in the western world the incidence is between 80% and 90%. The transmittance occurs already during childhood, perhaps by transfer from the mother, mainly via the saliva. During the active phase of the viral cycle, the Epstein-Barr virus produces about 100 different antigens, in the inactive phase around 10. The latter comprises among others the EBV nuclear antigen EBNA-1, which is closely correlated with a past infection and an immunity. The early antigen (EA) as well as the virus capsid antigen (VCA) from the active phase are also used as diagnostic markers. In a fresh infection, IgM antibodies against VCA and EA are determined by immunofluorescence or ELISA. Later VCA IgG and afterwards EBNA-1 IgG antibodies appear. The simultaneous activation of VCA IgM and EBNA-1 IgG indicates correspondingly a reactivation of a latent EBV infection. The Immunolab EBNA-1 IgG ELISA monitors a past infection satisfactorily and can be utilized for the assessment of blood samples before transfusions or transplantations and the exclusion of transmittance between children. 3. Principle of the Test The GenWay EBV EBNA-1 IgM antibody test kit  is based on the principle of the enzyme immunoassay (EIA). EBV EBNA-1 antigen is bound on the surface of the microtiter strips. Diluted sample serum or ready-to-use standards are pipetted into the wells of the microtiter plate. A binding between the IgM antibodies of the serum and the immobilized EBV EBNA-1 antigen takes place. After a one hour incubation at room temperature, the plate is rinsed with diluted wash solution, in order to remove unbound material. Then ready-to-use anti-human-IgM peroxidase conjugate is added and incubated for 30 minutes. After a further washing step, the substrate (TMB) solution is pipetted and incubated for 20 minutes, inducing the development of a blue dye in the wells. The color development is terminated by the addition of a stop solution, which changes the color from blue to yellow. The resulting dye is measured spectrophotometrically at the wavelength of 450 nm. The concentration of the IgM antibodies is directly proportional to the intensity of the colorAdditional Information: Name EBV EBNA-1 IgM ELISA Related Product Names EBV EBNA-1 IgM ELISA Intended Use Research Use Only