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Product Name: Epstein-Barr Virus (VCA) IgM ELISA
# of Samples: 1 x 96 Assays
Intended Use: The Epstein-Barr Virus (EBV) IgM-ELISA is intended for the qualitative determination of IgM class antibodies against Epstein-Barr virus viral capsid antigen (VCA) in human serum or plasma (citrate).
Introduction: Epstein-Barr Virus (EBV) is a member of the herpesvirus family (Gamma subgroup, DNA virus of 120-200 nm) and one of the most common human viruses. The virus occurs worldwide, and most people become infected with EBV sometime during their lives. Transmission of the virus is almost impossible to prevent since many healthy people can carry and spread the virus intermittently for life. Infants become susceptible to EBV as soon as maternal antibody protection disappears. Infection of children usually causes no symptoms. Infection during adolescence or young adulthood causes infectious mononucleosis 35% to 50% of the time.
Infectious mononucleosis is almost never fatal. There are no known associations between active EBV infection and problems during pregnancy, such as miscarriages or birth defects. Although the symptoms of infectious mononucleosis usually resolve in 1 or 2 months, EBV remains dormant or latent in a few cells in the throat and blood for the rest of the persons life. Periodically, the virus can reactivate and is commonly found in the saliva of infected persons. This reactivation usually occurs without symptoms of illness.
EBV also establishes a lifelong dormant infection in some cells of the bodys immune system. A late event in a very few carriers of this virus is the emergence of Burkitt´s lymphoma and nasopharyngeal carcinoma, but EBV is probably not the sole cause of these malignancies.
The presence of virus resp. infection may be identified by
Serology: mono spot test, Detection of antibodies by ELISA
The optimal combination of serologic testing consists of the titration of four markers: IgM and IgG to the viral capsid antigen (VCA), IgM to the early antigen, and antibody to EBV nuclear antigen (EBNA). IgM to VCA appears early in infection and disappears within 4 to 12 weeks. IgG to VCA appears in the acute phase, peaks at 2 to 4 weeks after onset, declines slightly, and then persists for life.
If antibodies to the viral capsid antigen are not detected, the patient is susceptible to EBV infection.
Principles of the assay: The qualitative immunoenzymatic determination of IgM-class antibodies against Epstein-Barr Virus is based on the ELISA (Enzyme-linked Immunosorbent Assay) technique.
Microtiter strip wells are precoated with Epstein-Barr Virus antigens to bind corresponding antibodies of the specimen. After washing the wells to remove all unbound sample material horseradish peroxidase (HRP) labelled anti-human IgM conjugate is added. This conjugate binds to the captured Epstein-Barr Virus-specific antibodies. The immune complex formed by the bound conjugate is visualized by adding Tetramethylbenzidine- (TMB) substrate which gives a blue reaction product. The intensity of this product is proportional to the amount of Epstein-Barr Virus-specific IgM antibodies in the specimen. Sulphuric acid is added to stop the reaction. This produces a yellow endpoint colour. Absorbance at 450 nm is read using an ELISA microwell plate reader.
Storage and Stability: The reagents are stable up to the expiry date stated on the label when stored at 2...8 °C.
Limitations of the Test: Bacterial contamination or repeated freeze-thaw cycles of the specimen may affect the absorbance values. Diagnosis of an infectious disease should not be established on the basis of a single test result. A precise diagnosis should take into consideration clinical history, symptomatology as well as serological data.
In immunocompromised patients and newborns serological data only have restricted value.
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