Abstract
BackgroundStandardized and sensitive assays for Epstein Barr Virus (EBV) are needed to define universal cutoff for treatment initiation in allogeneic hematopoietic stem cells transplant recipients. In a context of accreditation and the availability of EBV international standard, we evaluated the Abbott RealTime EBV (RT) assay for EBV quantification in whole blood.MethodsThe RT assay was compared on 282 prospective clinical samples with the Artus EBV PCR Kit V1 assay (V1) and we analyzed the kinetics of EBV load in 11 patients receiving rituximab treatment.ResultsThe estimated limit of detection was 88 IU/mL. The assay was linear (r2 = 0.9974) in the range of all samples tested (100 to 1,000,000 IU/mL). Intra-assay coefficients of variation (CV) ranged between 0.35 and 1.35%, and inter-assay CV between 3.40 and 4.5%. On samples above the limit of quantification, the two assays were strongly correlated. EBV RT values were on average 0.30 log10 IU/mL lower than those measured with the V1 assay. In patients treated with rituximab, the RT assay remained positive in 5 patients at the time it dropped below undetectable levels with the V1 assay.ConclusionsIn conclusion, the RT assay is a reliable assay for EBV load in whole blood. Its sensitivity will enable to estimate the kinetics of EBV load and the impact of treatments to control EBV reactivations.
Highlights
Standardized and sensitive assays for Epstein Barr Virus (EBV) are needed to define universal cutoff for treatment initiation in allogeneic hematopoietic stem cells transplant recipients
Results of measurements of EBV DNA loads performed with commercially available assays might differ significantly, according to the extraction method used, which is a source of variability with whole
Reporting EBV DNA quantification in international unit (IU) is recommended and industrials develop their assays according to this international standard
Summary
Standardized and sensitive assays for Epstein Barr Virus (EBV) are needed to define universal cutoff for treatment initiation in allogeneic hematopoietic stem cells transplant recipients. Especially allogeneic hematopoietic stem cell (HSCT) or solid-organ transplant recipients, EBV is associated with post-transplant lymphoproliferative disorders (PTLD) [4, 5]. As EBV DNA load in blood is taken into account for preemptive strategies, accurate and reliable quantification is necessary for the management of patients after transplant [9,10,11,12,13]. No universal quantitative cutoff of EBV DNA load to start preemptive treatment has been defined yet. Only few studies describe the dynamics of EBV DNA load after rituximab injection [14]
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