Clinical validation of an in-house quantitative real time PCR assay for cytomegalovirus infection using the 1st WHO International Standard in kidney transplant patients

Autor: Cassia F.B. Caurio, Odelta S. Allende, Roger Kist, Kênya L. Santos, Izadora C.S. Vasconcellos, Franciéli P. Rozales, Daiane F. Dalla Lana, Bruno M. Praetzel, Ana Paula Alegretti, Alessandro C. Pasqualotto
Jazyk: English<br />Portuguese
Rok vydání: 2021
Předmět:
Zdroj: Brazilian Journal of Nephrology, Vol 43, Iss 4, Pp 530-538 (2021)
Druh dokumentu: article
ISSN: 2175-8239
DOI: 10.1590/2175-8239-jbn-2020-0214
Popis: 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
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