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BMC Immunol. 2017 Mar 7;18(1):15. doi: 10.1186/s12865-017-0194-z.

Validation of T-Track® CMV to assess the functionality of cytomegalovirus-reactive cell-mediated immunity in hemodialysis patients.

Author information

1
Department of Nephrology, University Medical Center Regensburg, Regensburg, Germany. Bernhard.Banas@ukr.de.
2
Department of Nephrology, University Medical Center Regensburg, Regensburg, Germany.
3
Dialysis Center Landshut, Landshut, Germany.
4
5th Department of Medicine, University Medical Center Mannheim, Medical Faculty Mannheim of the University Heidelberg, Mannheim, Germany.
5
Lophius Biosciences GmbH, Regensburg, Germany.
6
Institute of Clinical Microbiology and Hygiene, University of Regensburg, Regensburg, Germany.
7
Dialysis Center Schwandorf, Schwandorf, Germany.

Abstract

BACKGROUND:

Uncontrolled cytomegalovirus (CMV) replication in immunocompromised solid-organ transplant recipients is a clinically relevant issue and an indication of impaired CMV-specific cell-mediated immunity (CMI). Primary aim of this study was to assess the suitability of the immune monitoring tool T-Track® CMV to determine CMV-reactive CMI in a cohort of hemodialysis patients representative of patients eligible for renal transplantation. Positive and negative agreement of T-Track® CMV with CMV serology was examined in 124 hemodialysis patients, of whom 67 (54%) revealed a positive CMV serostatus. Secondary aim of the study was to evaluate T-Track® CMV performance against two unrelated CMV-specific CMI monitoring assays, QuantiFERON®-CMV and a cocktail of six class I iTAg™ MHC Tetramers.

RESULTS:

Positive T-Track® CMV results were obtained in 90% (60/67) of CMV-seropositive hemodialysis patients. In comparison, 73% (45/62) and 77% (40/52) positive agreement with CMV serology was achieved using QuantiFERON®-CMV and iTAg™ MHC Tetramer. Positive T-Track® CMV responses in CMV-seropositive patients were dominated by pp65-reactive cells (58/67 [87%]), while IE-1-responsive cells contributed to an improved (87% to 90%) positive agreement of T-Track® CMV with CMV serology. Interestingly, T-Track® CMV, QuantiFERON®-CMV and iTAg™ MHC Tetramers showed 79% (45/57), 87% (48/55) and 93% (42/45) negative agreement with serology, respectively, and a strong inter-assay variability. Notably, T-Track® CMV was able to detect IE-1-reactive cells in blood samples of patients with a negative CMV serology, suggesting either a previous exposure to CMV that yielded a cellular but no humoral immune response, or TCR cross-reactivity with foreign antigens, both suggesting a possible protective immunity against CMV in these patients.

CONCLUSION:

T-Track® CMV is a highly sensitive assay, enabling the functional assessment of CMV-responsive cells in hemodialysis patients prior to renal transplantation. T-Track® CMV thus represents a valuable immune monitoring tool to identify candidate transplant recipients potentially at increased risk for CMV-related clinical complications.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02630537.

KEYWORDS:

CMV; Cell-mediated immunity; Cytomegalovirus; Hemodialysis; IE-1; IFN-γ ELISpot; QuantiFERON®-CMV; T-Track® CMV; iTAg™ MHC Tetramers; pp65

PMID:
28270092
PMCID:
PMC5339958
DOI:
10.1186/s12865-017-0194-z
[Indexed for MEDLINE]
Free PMC Article

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