Clinical validation of a novel enzyme‐linked immunosorbent spot assay‐based in?vitro in?vitro diagnostic assay to monitor cytomegalovirus‐specific cell‐mediated immunity in kidney transplant recipients: a multicenter, longitudinal, prospective, observational study

摘要

Summary Impaired cytomegalovirus ( CMV )‐specific cell‐mediated immunity ( CMV ‐ CMI ) is a major cause of CMV reactivation and associated complications in solid‐organ transplantation. Reliably assessing CMV ‐ CMI is desirable to individually adjust antiviral and immunosuppressive therapy. This study aimed to evaluate the suitability of T‐Track ? CMV , a novel IFN ‐γ ELIS pot 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 6?months post‐transplantation. Ninety‐five percent and 88–92% ELIS pot 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 ELIS pot assay to monitor patients' immunosuppressive state. Interestingly, median pp65‐specific response was ninefold 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 ELIS pot 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 (ClinicalTrials.gov Identifier: NCT 02083042).