@article{BanasSteublRendersetal.2018,
  author    = {Banas, Bernhard and Steubl, Dominik and Renders, Lutz and Chittka, Dominik and Banas, Miriam C. and Wekerle, Thomas and Koch, Martina and Witzke, Oliver and M{\"u}hlfeld, Anja and Sommerer, Claudia and Habicht, Antje and Hugo, Christian and H{\"u}nig, Thomas and Lindemann, Monika and Schmidt, Traudel and Rascle, Anne and Barabas, Sascha and Deml, Ludwig and Wagner, Ralf and Kr{\"a}mer, Bernhard K. and Kr{\"u}ger, Bernd},
  title     = {Clinical validation of a novel enzyme-linked immunosorbent spot assay-based in vitro diagnostic assay to monitor cytomegalovirus-specific cell-mediated immunity in kidney transplant recipients: a multicenter, longitudinal, prospective, observational study},
  series = {Transplant International},
  volume    = {31},
  journal   = {Transplant International},
  doi       = {10.1111/tri.13110},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-221468},
  pages     = {436-450},
  year      = {2018},
  abstract  = {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 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 6 months post-transplantation. Ninety-five percent 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 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 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 (ClinicalTrials.gov Identifier: NCT02083042).},
  language  = {en}
}