The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus (EBV) IgG Plus Test System is intended for the qualitative detection of IgG class antibody to three separate EBV Antigens (EBV-VCA gp-125, total EBV-EA, and recombinant EBNA-1) in human serum using the AtheNA Multi-Lyte System. The test system is intended to be used as an aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and to provide epidemiological information on the disease caused by Epstein-Barr Virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas. This test is for In Vitro diagnostic use only.
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the Epstein-Barr virus nuclear antigen (EBNA) of Epstein-Barr virus (EBV) in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.