Roche announced that it has launched the Elecsys EBV panel in countries accepting the CE Mark. Roche will file for approval with the U.S. Food and Drug Administration (FDA) in the future, according to a news release from the company.
The Elecsys EBV panel consists of three immunoassays: Elecsys EBV IgM, Elecsys EBV VCA IgG, and Elecsys EBV EBNA IgG, that detect antibodies specific to the Epstein-Barr virus (EBV), at different stages of infection. When used in combination, the three tests can help to define how far the infection has progressed in a patient.
Epstein-Barr Virus is one of the most common viruses in humans, infecting more than 90% of the global population by adulthood. It is mainly transmitted by saliva, or via organ or cell transplants. After the first infection, EBV remains in a dormant state for life. Clinical symptoms vary according to the immune status of the patients and people with weakened immune systems may develop more severe symptoms.
“The launch of the Elecsys EBV panel is an important step for the diagnosis of infections in transplant patients as it gives clear and accurate results from a single sample,” said Thomas Schinecker, CEO of Roche Diagnostics. “The tests help to provide the information clinicians need to diagnose and treat their patients quickly, effectively reducing the need for further confirmatory testing.”
EBV testing with immunoassays, from a blood sample, has a number of clinical uses. EBV is used to confirm the diagnosis of glandular fever in people with clinical signs and symptoms and to rule out other acute diseases with a similar clinical picture, such as certain infections in pregnant women that may cause congenital disorders. Knowing the EBV status of donors and recipients of organ and cell transplants is important, as recipients typically have a weaker immune system and may be at risk of complications.
Roche said that the Elecsys EBV panel correctly classifies a high percentage of routine samples, when determining the stage of EBV infection. This means that less confirmatory testing is required, saving time and resources for the laboratory, as well as potentially leading to more effective patient management.
