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

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 Muehlfeld, Anja and Sommerer, Claudia and Habicht, Antje and Hugo, Christian and Huenig, Thomas and Lindemann, Monika and Schmidt, Traudel and Rascle, Anne and Barabas, Sascha and Deml, Ludwig and Wagner, Ralf and Kraemer, Bernhard K. and Krueger, Bernd (2018) Clinical validation of a novel enzyme-linked immunosorbent spot assay-based invitro diagnostic assay to monitor cytomegalovirus-specific cell-mediated immunity in kidney transplant recipients: a multicenter, longitudinal, prospective, observational study. TRANSPLANT INTERNATIONAL, 31 (4). pp. 436-450. ISSN 0934-0874, 1432-2277

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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((R)) CMV, a novel IFN- 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 6months 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((R)) CMV is a highly sensitive IFN- 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).

Item Type: Article
Uncontrolled Keywords: CD8 T-CELLS; CMV INFECTION; ELISPOT-ASSAY; ORGAN TRANSPLANT; RISK-STRATIFICATION; MEMORY T; NK CELLS; DISEASE; RESPONSES; PROTECTION; CMV-specific cell-mediated immunity; cytomegalovirus; IFN- ELISpot; immunomonitoring; invitro diagnostic; kidney or renal transplantation
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Abteilung für Nephrologie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 19 Mar 2020 07:55
Last Modified: 19 Mar 2020 07:55
URI: https://pred.uni-regensburg.de/id/eprint/14856

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