BACKGROUND 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. 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. METHODS The 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. RESULTS The 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. CONCLUSIONS In 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.

中文翻译：

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全血中爱泼斯坦-巴尔病毒的自动定量，用于监测移植后的淋巴增生性疾病。

背景技术需要针对爱泼斯坦巴尔病毒（EBV）的标准化和灵敏的测定法，以定义用于异基因造血干细胞移植受体中治疗起始的通用截止值。在获得认可和EBV国际标准的前提下，我们评估了全血EBV定量的雅培实时EBV（RT）测定法。方法采用Artus EBV PCR试剂盒V1分析（V1）对282份前瞻性临床样本进行RT分析，我们分析了11位接受利妥昔单抗治疗的患者的EBV负荷动力学。结果估计的检出限为88 IU / mL。在所有测试样品的范围内（100至1,000,000 IU / mL），测定均为线性（r2 = 0.9974）。批内变异系数（CV）在0.35和1.35％之间，批间变异系数在3.40和4.5％之间。在超过定量限的样品上，两种测定法具有很强的相关性。EBV RT值平均比使用V1分析测得的值低0.30 log10 IU / mL。在接受利妥昔单抗治疗的患者中，当RT降至低于V1检测不到的水平时，RT检测在5例患者中保持阳性。结论总之，RT分析是一种可靠的全血EBV含量测定方法。它的敏感性将能够估计EBV负荷的动力学以及控制EBV活化的治疗方法的影响。结论总之，RT分析是一种可靠的全血EBV含量测定方法。它的敏感性将能够估计EBV负荷的动力学以及控制EBV活化的治疗方法的影响。结论总之，RT分析是一种可靠的全血EBV含量测定方法。它的敏感性将能够估计EBV负荷的动力学以及控制EBV活化的治疗方法的影响。