Clinical Validation of a Novel ELISpot-Based In Vitro Diagnostic Assay to Monitor CMV-Specific Cell-Mediated Immunity in Kidney Transplant Recipients
1University Clinic, Regensburg, Germany
2Clinic rechts der Isar TUM, Munich, Germany
3Medical University, Vienna, Austria
4University Clinic, Hamburg-Eppendorf, Germany
5University Hospital, Essen, Germany
6Uniklinik RWTH, Aachen, Germany
7University Hospital, Heidelberg, Germany
8LMU Medical Center, Munich, Germany
9University Hospital, Dresden, Germany
10University Hospital, Wuerzburg, Germany
11Lophius Biosciences, Regensburg, Germany
12UMM Uni. Heidelberg, Mannheim, Germany.
Meeting: 2018 American Transplant Congress
Abstract number: A191
Keywords: Cytomeglovirus, Immunosuppression, Kidney, Monitoring
Session Information
Session Name: Poster Session A: Kidney Transplant Goes Viral
Session Type: Poster Session
Date: Saturday, June 2, 2018
Session Time: 5:30pm-7:30pm
Presentation Time: 5:30pm-7:30pm
Location: Hall 4EF
Impaired cytomegalovirus (CMV)-specific cell-mediated immunity (CMV-CMI) is a major cause ofCMV 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 a novel IFN-γ ELISpot assay (T-Track® CMV), based on the stimulation of PBMC with pp65 and IE-I CMV proteins, to monitor CMV-CMI following kidney transplantation.
A prospective, longitudinal, observational, multicenter study was conducted in 86 intermediate risk (D-/R+, D+/R+) renal transplant recipients. Patients underwent pre-emptive antiviral therapy. CMV-CMI, CMV viral load and clinical complications were monitored over six months post-transplantation.
95% and 88-92% of IFN-γ ELISpot test results were positive pre- and post-transplantation, respectively, demonstrating the sensitivity of the assay in immunocompromised patients. CMV-specific response was reduced following immunosuppressive treatment and increased in patients with graft rejection, indicating the ability of the ELISpot assay to monitor the 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, this novel IFN-γ ELISpot assay (T-Track® CMV) is a highly sensitive immune-monitoring tool, suitable for the follow-up of renal transplant recipients, and with a potential use for the risk assessment of CMV-related clinical complications.
CITATION INFORMATION: Banas B., Steubl D., Renders L., Chittka D., Banas M., Wekerle T., Koch M., Witzke O., Muehlfeld A., Sommerer C., Habicht A., Hugo C., Huenig T., Lindemann M., Schmidt T., Rascle A., Barabas S., Deml L., Wagner R., Kraemer B., Krueger B. Clinical Validation of a Novel ELISpot-Based In Vitro Diagnostic Assay to Monitor CMV-Specific Cell-Mediated Immunity in Kidney Transplant Recipients Am J Transplant. 2017;17 (suppl 3).
To cite this abstract in AMA style:
Banas B, Steubl D, Renders L, Chittka D, Banas M, Wekerle T, Koch M, Witzke O, Muehlfeld A, Sommerer C, Habicht A, Hugo C, Huenig T, Lindemann M, Schmidt T, Rascle A, Barabas S, Deml L, Wagner R, Kraemer 11B, Krueger B. Clinical Validation of a Novel ELISpot-Based In Vitro Diagnostic Assay to Monitor CMV-Specific Cell-Mediated Immunity in Kidney Transplant Recipients [abstract]. https://atcmeetingabstracts.com/abstract/clinical-validation-of-a-novel-elispot-based-in-vitro-diagnostic-assay-to-monitor-cmv-specific-cell-mediated-immunity-in-kidney-transplant-recipients/. Accessed May 16, 2025.« Back to 2018 American Transplant Congress