SeraSpot® Anti-EBV-4 IgG / SeraSpot® Anti-EBV-3 IgM

Intended use:

The SeraSpot® Anti-EBV-4 IgG / SeraSpot® Anti-EBV-3 IgM test is an in vitro diagnostic device (spotimmunoassay, SIA) for the detection of EBV-specific IgG or IgM antibodies in human serum or plasma samples.

General information:

The Epstein-Barr-Virus (EBV, also known as Human gammaherpesvirus 4) is a small, enveloped, double-stranded DNA virus in the family of Herpesviridae. The DNA contains internal and terminal
repetitive sequences, whereby the terminal sequences enable a ring formation for the DNA replication.
The EBV is the aetiologic agent of the infectious mononucleosis (glandular fever). After a symptomatic or asymptomatic EBV infection the virus could establish a lifelong persistent infection. The virus is mainly transmitted through saliva (contact infection), a transmission through transplantations or blood transfusions is rare. At the age of 4, the infection rate is about 50%, from the age of 20 around 90% and from the age of 50 up to 99%.
An infection during childhood is often asymptomatic, but in case of young adults and adults the infection could lead in 30 to 60 % of all cases to the onset of an infectious mononucleosis. After an incubation time of 10 to 50 days (the average incubation time is 10 to 15 days) the first symptoms could occur. The common symptoms are fever, lymphadenopathy (lymphoma), hepatosplenomegaly (enlargement of the liver and spleen), pharyngitis (sore throat) and tonsillitis. More respiratory symptoms could be dominant in children. In immunocompetent persons the disease is self-limiting and last no longer than 3 weeks.
Especially EBV is associated in immunosuppressed patients with different lymphoproliferative diseases, such as the Burkitt’s lymphoma (lymph node cancer) and nasopharyngeal carcinoma (nose and throat cancer).
During primary infection with EBV, the epithelial cells and B-lymphocytes in the oropharyngeal tract are infected. The virus is spread through the B-lymphocytes in the entire body. The infection could be lytic or latent.
The lytic infection is mainly in epithelial cells and leads to the lysis of the infected cells and the release of virus particles. During the lytic phase regulatory proteins, which belong to the group of “immediately early antigen” (IEA) and “early antigen” (EA), are synthesized to enable the production of the viral DNA,

structural components of the virion (“viral capsid antigen” (VCA)) and membrane proteins (MA). The gene products possess antigenic characteristics and initiate the formation of antibodies.
B-lymphocytes are usually latent infected. The viral genome is in the cell nucleus of the infected cell in an extrachromosomal form (episom). This leads to an immortalization of the B-cells and to the transformation of continuously growing blasts. In immunocompetent persons the growth of the transformed cells is controlled by cytotoxic T-lymphocytes and NK cells. Especially the CD8margin-right: 0px; margin-bottom: 10px; margin-left: 0px; line-height: 1.3em; overflow-wrap: break-word; font-size: 18px; color: rgb(77, 77, 77); font-family: "Stone Sans ITC W01 Semi Bold" !important;margin-right: 0px; margin-bottom: 1em; margin-left: 1.5em; padding: 0px; border: 0px; vertical-align: baseline; font-size: 16px; list-style-position: initial; list-style-image: initial; color: rgb(68, 68, 68); font-family: "Titillium Web";margin: 0px 0px 0px 0.85em; padding: 0px; border: 0px; vertical-align: baseline;https://clinical.r-biopharm.com/products/spotsight-scan/margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; color: rgb(46, 46, 46); overflow-wrap: break-word; outline: none 0px; text-decoration-line: underline !important;margin: 0px 0px 0px 0.85em; padding: 0px; border: 0px; vertical-align: baseline;https://clinical.r-biopharm.com/products/spotsight-plate-mono/margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; color: rgb(46, 46, 46); overflow-wrap: break-word; outline: none 0px; text-decoration-line: underline !important;margin: 0px 0px 0px 0.85em; padding: 0px; border: 0px; vertical-align: baseline;https://clinical.r-biopharm.com/products/spotsight-strip/margin: 0px; padding: 0px; border: 0px; vertical-align: baseline; color: rgb(46, 46, 46); overflow-wrap: break-word; outline: none 0px; text-decoration-line: underline !important;product-details0margin: 0px 55px 30px 0px; padding: 0px; border: 0px; vertical-align: baseline; font-size: 16px; width: 517px; overflow: hidden; float: left; color: rgb(68, 68, 68); font-family: "Titillium Web"; background-color: rgb(255, 255, 255);margin: 20px 0px 10px; padding: 0px; border: 0px; vertical-align: baseline; font-size: 18px; color: rgb(77, 77, 77);margin: 0px; padding: 0px; border: 0px; vertical-align: baseline;margin: 0px; padding: 0px; border: 0px; vertical-align: baseline;specrowmargin: 0px; padding: 4px 8px 2px; border: 1px solid rgb(255, 255, 255); vertical-align: baseline; font-weight: 400; width: 200px; color: rgb(77, 77, 77) !important; background-color: rgb(255, 245, 204) !important; font-family: "Stone Sans ITC W01 Semi Bold" !important;margin: 0px; padding: 12px; border-top: 1px solid rgb(227, 229, 230); border-bottom: 1px solid rgb(227, 229, 230); border-image: initial; vertical-align: baseline; border-right: 0px !important; border-left: none !important;margin: 0px; padding: 0px; border: 0px; vertical-align: baseline;specrowmargin: 0px; padding: 4px 8px 2px; border: 1px solid rgb(255, 255, 255); vertical-align: baseline; font-weight: 400; width: 200px; color: rgb(77, 77, 77) !important; background-color: rgb(255, 245, 204) !important; font-family: "Stone Sans ITC W01 Semi Bold" !important;margin: 0px; padding: 12px; border-top: 1px solid rgb(227, 229, 230); border-bottom: 1px solid rgb(227, 229, 230); border-image: initial; vertical-align: baseline; border-right: 0px !important; border-left: none !important;margin: 0px; padding: 0px; border: 0px; vertical-align: baseline;specrowmargin: 0px; padding: 4px 8px 2px; border: 1px solid rgb(255, 255, 255); vertical-align: baseline; font-weight: 400; width: 200px; color: rgb(77, 77, 77) !important; background-color: rgb(255, 245, 204) !important; font-family: "Stone Sans ITC W01 Semi Bold" !important;margin: 0px; padding: 12px; border-top: 1px solid rgb(227, 229, 230); border-bottom: 1px solid rgb(227, 229, 230); border-image: initial; vertical-align: baseline; border-right: 0px !important; border-left: none !important;margin: 0px; padding: 0px; border: 0px; vertical-align: baseline;specrowmargin: 0px; padding: 4px 8px 2px; border: 1px solid rgb(255, 255, 255); vertical-align: baseline; font-weight: 400; width: 200px; color: rgb(77, 77, 77) !important; background-color: rgb(255, 245, 204) !important; font-family: "Stone Sans ITC W01 Semi Bold" !important;margin: 0px; padding: 12px; border-top: 1px solid rgb(227, 229, 230); border-bottom: 1px solid rgb(227, 229, 230); border-image: initial; vertical-align: baseline; border-right: 0px !important; border-left: none !important;+>IgG: 97,8 %
IgM: 100 %