Immune cell function assays in the diagnosis of infection in pediatric liver transplantation: an open-labeled, two center prospective cohort study.

BACKGROUND: Limited studies have been performed in assessment of immune status of pediatric liver transplants (PLTs). We conducted this study to evaluate Cylex immune cell function assay in diagnosis of infection and its potential clinical application in Chinese infant PLTs.

METHODS: In this prospective cohort study, 227 infant PLTs from two medical centers were enrolled, and 216 completed the study. Cylex ATP values were measured before and after liver transplantation (LT) at week 1, 2, 3, 4, 8, 12 and 24 respectively. Accordingly, patients' clinical records, including demographic data, liver function results, tacrolimus dosages and concentrations were collected and analyzed.

RESULTS: One hundred and sixty of 216 PLTs (74.1%) were diagnosed infection based on the parameters including abnormal vital signs, imaging changes, and pathogens detection, while 44 (20.4%) were clinically stable and 12 (5.6%) experienced acute rejection. The median Cylex ATP value in infant PLTs post-surgery reduced significantly in infection group compared to stable group (median, 137 vs . 269 ng/mL, P<0.001). Receiver operating characteristic (ROC) curve analysis determined that the cut-off value of Cylex ATP was 152 ng/mL in diagnosis of infection [area under the curve (AUC): 0.784, 95% CI: 0.720-0.848]. Meanwhile, Cylex ATP value showed no correlation to tacrolimus dosage, blood concentration, dose-normalized concentration/dose ratio or Kaup index. However, it tended to correlate weakly with the white blood cell (WBC) number (R =0.462, P<0.0001) and lymphocyte counts (R =0.363, P<0.0001).

CONCLUSIONS: In this study, we demonstrated that low Cylex ATP represented partly over-immunosuppression and had diagnostic value in infant PLTs with infections, which might assist individualized immunosuppression in PLT patients.