This study aims to validate whether Lophius Biosciences Kit T-Track® CMV is suitable to assess the functionality of CMV-specific cell-mediated immunity (CMI) and to determine a protective cut-off value for CMV reactivations/disease in kidney transplant recipients. Lophius kit T-Track® CMV represents a highly standardized and sensitive diagnostic tool to assess the functionality of a network of clinically relevant CMV-reactive effector cells. It is based on the stimulation of peripheral blood mononuclear cells (PBMC) with urea-formulated immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Determination of changes in pp65 and/or IE-1 specific CMI applying T-TrackĀ® CMV
Timeframe: before Tx, week 3,6,9,12,15,18 and 21 after Tx and unscheduled visits in case of suspicion of CMV related complications; individual observation period 6 months