April 8, 2021—Roche’s Elecsys EBV panel has launched in countries accepting the CE mark. The panel consists of the Elecsys EBV IgM, EBV VCA IgG, and EBV EBNA IgG immunoassays and detects antibodies specific to the Epstein-Barr virus at different stages of infection.
“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,” Thomas Schinecker, CEO of Roche Diagnostics, said in a press release. “The tests help to provide the information clinicians need to diagnose and treat their patients quickly, effectively reducing the need for further confirmatory testing.”
The immunoassays have excellent clinical sensitivity and specificity, the company says, and a time to result of 18 minutes. The tests require a sample volume of between 6 μL and 35 μL, depending on the assay and analyzer.
Roche will file for FDA approval in the future.