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Transpl Int. 2018 Apr;31(4):436-450. doi: 10.1111/tri.13110. Epub 2018 Jan 16.

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.

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Department of Nephrology, University Medical Center Regensburg, Regensburg, Germany.
Department of Nephrology, Klinikum rechts der Isar, Technical University Munich, Munich, Germany.
Department of Surgery, Medical University of Vienna, Vienna, Austria.
Transplantation Immunology Research Group, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Departments of Nephrology and of Infectious Disease, University Hospital Essen, Essen, Germany.
Uniklinik RWTH Aachen, Aachen, Germany.
Division of Nephrology, University Hospital Heidelberg, Heidelberg, Germany.
Transplantation Center, Ludwig-Maximilians-University Medical Center Munich, Munich, Germany.
Department of Nephrology, Carl Gustav Carus University Medical Center Dresden, Dresden, Germany.
Institute of Virology and Immunobiology, University Medical Center Würzburg, Würzburg, Germany.
Institute for Transfusion Medicine, University Hospital Essen, Essen, Germany.
Lophius Biosciences, Regensburg, Germany.
Institute of Clinical Microbiology and Hygiene, University Medical Center Regensburg, Regensburg, Germany.
Vth Department of Medicine, University Medical Center Mannheim, Mannheim, Germany.


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 ( Identifier: NCT02083042).


CMV-specific cell-mediated immunity; IFN-γ ELISpot; cytomegalovirus; immunomonitoring; in vitro diagnostic; kidney or renal transplantation

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