Abstract
Introduction:Cytomegalovirus (CMV) is one of the most common agents of infection in solid organ transplant patients, with significant morbidity and mortality.Objective:This study aimed to establish a threshold for initiation of preemptive treatment. In addition, the study compared the performance of antigenemia with qPCR results.Study design:This was a prospective cohort study conducted in 2017 in a single kidney transplant center in Brazil. Clinical validation was performed by comparing in-house qPCR results, against standard of care at that time (Pp65 CMV Antigenemia). ROC curve analysis was performed to determine the ideal threshold for initiation of preemptive therapy based on the qPCR test results.Results:Two hundred and thirty two samples from 30 patients were tested with both antigenemia and qPCR, from which 163 (70.26%) were concordant (Kappa coefficient: 0.435, p<0.001; Spearman correlation: 0.663). PCR allowed for early diagnoses. The median number of days for the first positive result was 50 (range, 24-105) for antigenemia and 42 (range, 24-74) for qPCR (p<0.001). ROC curve analysis revealed that at a threshold of 3,430 IU/mL (Log 3.54), qPCR had a sensitivity of 97.06% and a specificity of 74.24% (AUC 0.92617 ± 0.0185, p<0.001), in the prediction of 10 cells/105 leukocytes by antigenemia and physician's decision to treat.Conclusions:CMV Pp65 antigenemia and CMV qPCR showed fair agreement and a moderate correlation in this study. The in-house qPCR was revealed to be an accurate method to determine CMV DNAemia in kidney transplant patients, resulting in positive results weeks before antigenemia.
Highlights
Cytomegalovirus (CMV) is one of the most common agents of infection in solid organ transplant patients, with significant morbidity and mortality
From December 2016 to December 2017, 300 kidney transplant procedures were performed in the hospital, from which 51 patients participated in the study
Positive results were observed in 130 (56.0%) samples: 61 (46.9%) were positive for both methods, 68 samples (52.3%) were positive by quantitative real time PCR (qPCR) only, and 1 sample (0.008%) was only positive by antigenemia. qPCR and antigenemia tests were concordant in 163 samples (70.3%) (Kappa coefficient test=0.435; p
Summary
Cytomegalovirus (CMV) is one of the most common agents of infection in solid organ transplant patients, with significant morbidity and mortality. ROC curve analysis was performed to determine the ideal threshold for initiation of preemptive therapy based on the qPCR test results. The in-house qPCR was revealed to be an accurate method to determine CMV DNAemia in kidney transplant patients, resulting in positive results weeks before antigenemia. Cytomegalovirus (CMV) (Order Herpesvirales, Family Herpesviridae, Subfamily Betaherpesvirinae, Genus Cytomegalovirus, Species Human betaherpesvirus 5) is one of the most relevant causes of infection in transplant organ recipients, resulting in significant morbidity and mortality[1]. Most patients at risk of CMV infection/disease are monitored with diagnostic tests aiming for an early detection of CMV infection, in the so called ‘preemptive’ strategy. Due to large inter-assay variations, no universal consensus has been reached on the threshold to initiate therapy against CMV3–5
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