February 08, 2018 – T-Track® CMV is a Highly Sensitive Immune-Monitoring Tool
for Risk Stratification of Renal Transplant Recipients
The scientific publication outlines that T-Track® CMV is a highly sensitive assay for the immune monitoring of Cytomegalovirus (CMV)-seropositive renal transplant recipients, with the potential use for the risk assessment of CMV-related clinical complications. The paper was published in Transplant International1.
In this prospective longitudinal multicenter study, 86 kidney transplant recipients were followed over 6 months post-transplantation. CMV-specific cell-mediated immunity was monitored using T-Track® CMV, in parallel to the assessment of CMV viral load and of clinical complications. This study demonstrated the capability of T-Track® CMV not only to measure CMV-specific cell-mediated immunity in immunocompromised patients with high sensitivity (with 88-92% positive tests in patients under immunosuppressive treatment, compared to 95% before transplantation), but also to monitor changes in the patients’ CMV-specific immune status following the administration of immunosuppressive drugs.
In addition, T-Track® CMV test results (in response to one of the antigens provided in the IVD kit) were significantly higher in patients with a protective immunity, compared to patients requiring antiviral treatment, highlighting the potential predictive value of the assay.
“The recent publication nicely shows that T-Track® CMV is a valuable tool for the risk stratification of transplant patients and gives an outlook towards its ability to support personalized CMV management. Together with results of on-going clinical studies in allogeneic hematopoietic stem cell and solid-organ transplant recipients we are looking forward to broaden the routine use of our test and making the clinical advantages available to a large number of transplant patients”, said Bernd Merkl, CEO & Managing Director of Lophius Biosciences GmbH.
1) Banas et al. (2017). 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. Transpl Int. doi: 10.1111/tri.13110.