Clinical validation of a novel ELISpot ‐based in vitro diagnostic assay to monitor CMV‐specific cell‐mediated immunity in kidney transplant recipients: a multicenter, longitudinal, prospective, observational study

This study aimed to evaluate the suitability of T‐Track® CMV, a novel IFN‐γ ELISpot assay based on the stimulation of peripheral blood mononuclear cells with pp65 and IE‐I CMV proteins, to monitor CMV‐CMI following kidney transplantation. A prospective longitudinal multicenter study was conducted in 86 intermediate‐risk renal transplant recipients. CMV‐CMI, CMV viral load and clinical complications were monitored over six months post‐transplantation. 95% and 88‐92% ELISpot assays were positive pre‐ and post‐transplantation, respectively. CMV‐specific response was reduced following immunosuppressive treatment and increased in patients with graft rejection, indicating the ability of the ELISpot assay to monitor patients’ immunosuppressive state. Interestingly, median pp65‐specific response was 9‐fold higher in patients with self‐clearing viral load compared to antivirally‐treated patients prior to first viral load detection (p<0.001), suggesting that reactivity to pp65 represents a potential immunocompetence marker. Altogether, T‐Track® CMV is a highly sensitive IFN‐γ ELISpot assay, suitable for the immunomonitoring of CMV‐seropositive renal transplant recipients, and with a potential use for the risk assessment of CMV‐related clinical complications This article is protected by copyright. All rights reserved.
Source: Transplant International - Category: Transplant Surgery Authors: Tags: Original Article Source Type: research