Roche has launched the Elecsys Epstein-Barr Virus (EBV) panel, which consists of Elecsys EBV IgM, Elecsys EBV VCA IgG and Elecsys EBV EBNA IgG immunoassays, in countries accepting the CE Mark.
The panel uses a single blood sample to identify antibodies specific to EBV at various stages of infection.
When used together, the three tests can provide an understanding of how far the infection has progressed in a patient.
Needing a small sample volume of 6μL to 35μL, the immunoassays deliver a result in only 18 minutes.
Roche diagnostics CEO Thomas Schinecker said: “The tests help to provide the information clinicians need to diagnose and treat their patients quickly, effectively reducing the need for further confirmatory testing.”
Roche noted that EBV testing with immunoassays from a blood sample has numerous clinical benefits. EBV is used for confirming the diagnosis of glandular fever in individuals with clinical signs and symptoms while also ruling out other acute diseases with similar clinical pictures.
Furthermore, it is vital to understand the EBV status of donors and recipients in organ and cell transplants, since recipients usually have a weaker immune system.
Routine EBV testing and result analysis can be a strenuous task. Further tests are often needed to detect EBV infection stages, as they are unclear in roughly 5-10% of normal samples.
The Elecsys EBV panel accurately classifies the stage of EBV infection in a high percentage of routine samples, resulting in less confirmatory testing being needed.
This saves time and resources for labs and could aid in better management of patients.
Roche plans to submit an application to the US Food and Drug Administration (FDA) seeking approval for the panel soon.
Last month, the company signed a definitive merger agreement to completely acquire GenMark Diagnostics for a total transaction value of nearly $1.8bn.