March 31, 2021 – Roche announced that the Elecsys EBV panel has launched in countries accepting the CE Mark. Roche will file for approval with the FDA in the future.
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.
The immunoassays have excellent clinical sensitivity and specificity, and a short time to result of only 18 minutes. The tests require a small sample volume of between 6 μL to 35 μL, depending on the assay and analyzer. The addition of the EBV panel isd an important addition to the routine infectious diseases testing panel for Roche’s immunoassay portfolio.
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.
This further addition to the Roche EBV testing portfolio follows on from the announcement of the CE Mark and FDA authorization for the first Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems to improve care for transplant patients.