Intended Use
The ELISA Epstein-Barr Virus EBNA 1 IgG may be used as quantitative and qualitative tests for detection of human anti-Epstein-Barr Virus antibodies in serum or plasma. For sale in the U.S. for Research Use Only. Not for use in diagnostic procedure.
Contents of Kit
1. Break apart microtiter test strips each with 8 antigen coated single wells (altogether 96), 1 frame, the coating material is inactivated. 12
2. Standard serum (ready-to-use), Human serum in phosphate buffer with protein; negative for anti-HIV-Ab, anti-HBs-Ag (Hepatitis B-Virus-surface antigen) and anti-HCV-Ab; preservative: < 0.1% sodium azide, colouring: Amaranth O. 2 × 2 ml
3. Negative control serum (ready-to-use), Human serum in phosphate buffer with protein; negative for anti-HIV-Ab, anti-HBs-Ag (Hepatitis B-Virus-surface antigen) and anti-HCV-Ab; preservative: < 0.1% sodium azide, colouring: Lissamine green V. 2 ml
4. Anti-human-IgM-conjugate (ready-to-use), Anti-human-IgM from goat (polyclonal), conjugated to alkaline phosphatase, stabilized with protein stabilization solution, preservative: 0.01 % methylisothiazolone, 0.01 % bromnitrodioxane. 13 ml
5. Washing solution concentrate (sufficient for 1000ml), Sodium chloride solution with Tween 20, 30 mM Tris, preservative: < 0.1% sodium azide. 33.3 ml
6. Dilution buffer, Phosphate buffer with protein and Tween 20; preservative: < 0.1% sodium azide, 0.01 g/l Bromphenol blue sodium salt. 2 × 50 ml
7. Stopping solution, 1.2 N sodium hydroxide. 15ml
8. Substrate (ready-to-use), Para-nitrophenylphosphate, solvent free buffer, preservative: < 0.1 % sodium azide, (Substrate in unopened bottle may have a slightly yellow coloring. This does not reduce the quality of the product!). 13 ml
Storage
| Reagent | Storage | Stability |
| microtiter strips (antigen) | after opening at 2-8°C in closed aluminum bag with desiccant. Strips which are not used must be stored in the press-seal bag of aluminum compound foil under dry and airtight conditions! | 4 weeks |
| control sera / standard sera | after opening at 2-8°C | until expiry date; 24 months from date of production |
| conjugate | ready-to-use solution, at 2-8°C, Avoid contamination (sterile tips!) | until expiry date 28 months from date of production |
| washing solution | concentrate after opening at 2-8°C;
working dilution at 2-8°C;
working dilution at room temperature.
Bottles used for the working dilution should be cleaned regularly, discard cloudy solutions. | until expiry date;
2 weeks;
1 week |
| dilution buffer | after opening at 2-8°C, Discard cloudy solutions!;
unopened | 24 months;
until expiry date; 36 months from date of production |
| substrate | ready-to-use solution at 2-8°C, protected from light! Avoid contamination (sterile tips!) Discard when solution turns yellow (extinction against distilled water > 0.25). | until expiry date 24 months from date of production |
| stopping solution | after opening at room temperature | until expiry date |
General Description
Epstein-Barr Virus (EBV), a DNA virus, is a member of the Human Herpesvirus group and is pathogenic for humans.
EBV transmission takes place primarily via the saliva of infected individuals. Transfer of the virus via blood, blood products and bone marrow transplants have also been reported, but this mode of transmission is comparatively rare.
On primary infection, the cells of the salivary gland are infected first. At this stage of infection respiratory symptoms are very common. Due to the subsequent infection of B cells in the adjacent lymphoid tissue, the virus spreads throughout the body. Infection of B cells results in a polyclonal stimulation of lymphoproliferation which is normally controlled by the immune system. In the later course of infection, high fever, splenomegaly, lymphadenitis, thrombocytopenia and hepatitis may be observed. The disease resulting from primary infection is called infectious mononucleosis (IM) or glandular fever. Since viral transmission principally happens by oral contact, the primary infection has also been called "kissing disease". In rare cases acute mononucleosis may progress to a chronic disease, and reactivation of EBV has been observed in immunosuppressed patients.
EBV is closely associated with nasopharyngeal carcinoma, and Burkitt lymphoma (BL), is at least partly correlated with EBV. This B cell tumor of monoclonal origin is endemically clustered in tropical regions of Africa and Asia. The geographical distribution of BL correlates with that of malaria. Since it is believed that infections with Plasmodium have some influence on the immune system, it is suggested that malaria might be an important cofactor for the development of Burkitt lymphoma in these regions. Due to the complex structure of the virus, the tight regulation of the viral life cycle, and the appearance of latent or productive infections, the antibody response seen after EBV infection may be quite complex and therefore difficult to interpret.
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