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

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


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: NCT02630537.

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

Publication types

  • Comparative Study
  • Validation Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Viral / blood
  • Cells, Cultured
  • Cohort Studies
  • Cytomegalovirus / immunology*
  • Cytomegalovirus Infections / diagnosis*
  • Cytomegalovirus Infections / immunology
  • Female
  • Humans
  • Immediate-Early Proteins / immunology
  • Immunity, Cellular
  • Immunoassay
  • Immunocompromised Host*
  • Kidney Failure, Chronic / diagnosis*
  • Kidney Failure, Chronic / immunology
  • Kidney Failure, Chronic / therapy
  • Kidney Transplantation
  • Male
  • Middle Aged
  • Monitoring, Immunologic / methods
  • Observer Variation
  • Phosphoproteins / immunology
  • Renal Dialysis*
  • Sensitivity and Specificity
  • Viral Matrix Proteins / immunology
  • Waiting Lists


  • Antibodies, Viral
  • IE1 protein, cytomegalovirus
  • Immediate-Early Proteins
  • Phosphoproteins
  • Viral Matrix Proteins
  • cytomegalovirus matrix protein 65kDa

Associated data