Intended Use
Human VCA EBV (CSF) IgG ELISA kit is intended for in vitro diagnostic procedures in EBV induced and EBV associated diseases, such as infectious mononucleosis (IM) and the chronic active EBV infection. The test is also usefull in the diagnosis of Burkitt's lymphoma, nasopharyngeal carcinoma, carcinoma of the Waldeyer's ring and in characterisation of opportunistic lymphomas (oligo- and polyclonal). The other use of the test is in characterisation of chronic fatigue syndrome, in neuroinfections and immunosupression which is frequently associated with EBV reactivation.
Contents of Kit
1. 12 x 8 well breakaway strips coated with antigen
2. Standard A-F
3. Anti-humanIgG antibodies-Px conjugated (Px-conjugate)
4. Wash Buffer
5. Dilution buffer (DB)
6. Chromogenic substrate (TMB substrate)
7. Stop Solution
Storage
1. Store the unused strips in the provided plastic bag with the desiccant kept inside.
2. Store serum and CSF samples at temperature -18 to -28°C, undiluted in small aliquots. Avoid repeated freezing and thawing of samples.
3. Short term storage (up to one week) of thawed/fresh serum samples is possible at +2 to +10°C.
4. Do not store the diluted samples and the diluted Pxconjugate, always prepare fresh.
Precision
Intraassay variability: 4.9-5.2%
Interassay variability: 3.8-9.7%
Detection Limit
The limit of detection was calculated as the minimal concentration that was at the 95% confidence level different from the Blank. The limit of detection was 1,6 A.U./mL
Sensitivity
The diagnostic sensitivity was measured by testing the population sample that is expected to have anti-VCA IgG antibodies (blood donors, patients with active EBV infection). The results were confirmed by other commercial test. The diagnostic sensitivity was 98.1%.
General Description
The Epstein–Barr virus (EBV), also called human herpesvirus 4 (HHV-4), is a virus of the herpes family, which includes herpes simplex virus 1 and 2, and is one of the most common viruses in humans. It is best known as the cause of infectious mononucleosis. It is also associated with particular forms of cancer, particularly Hodgkin's lymphoma, Burkitt's lymphoma, nasopharyngeal carcinoma, and central nervous systemlymphomas associated with HIV. Finally, there is evidence that infection with the virus is associated with a higher risk of certain autoimmune diseases, especially dermatomyositis, systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, and multiple sclerosis. Most people become infected with EBV and gain adaptive immunity. In the United States, about half of all five-year-olds and 90–95% of adults have evidence of previous infection. Infants become susceptible to EBV as soon as maternal antibody protection disappears. Many children become infected with EBV, and these infections usually cause no symptoms or are indistinguishable from the other mild, brief illnesses of childhood. In the United States and in other developed countries, many people are not infected with EBV in their childhood years. When infection with EBV occurs during adolescence or teenage years, it causes infectious mononucleosis 35% to 69% of the time.
Citations
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