Université de Paris Diderot, INSERM U976, Paris, France.
Laboratoire de Microbiologie, Hôpital Saint-Louis, APHP, Paris, France.
Virol J. 2020 Feb 3;17(1):20. doi: 10.1186/s12985-020-1285-7.
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.
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.
The estimated limit of detection was 88 IU/mL. The assay was linear (r = 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 log 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.
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.
需要标准化和敏感的 Epstein Barr 病毒 (EBV) 检测方法，以确定异基因造血干细胞移植受者开始治疗的通用临界值。在认证和 EBV 国际标准的可用性的背景下，我们评估了 Abbott RealTime EBV (RT) assay 对全血中 EBV 定量的检测能力。
将 RT assay 与 Artus EBV PCR Kit V1 assay（V1）在 282 份前瞻性临床样本上进行了比较，并分析了 11 名接受利妥昔单抗治疗的患者的 EBV 载量动力学。
估计的检测下限为 88 IU/mL。该检测在所有测试样本（100 至 1,000,000 IU/mL）的范围内呈线性（r=0.9974）。批内变异系数 (CV) 范围在 0.35%至 1.35%之间，批间 CV 范围在 3.40%至 4.5%之间。在定量限以上的样本中，两种检测方法具有很强的相关性。与 V1 检测相比，RT 检测的 EBV RT 值平均低 0.30 log IU/mL。在接受利妥昔单抗治疗的患者中，在 V1 检测法降至不可检测水平时，RT 检测法仍在 5 名患者中呈阳性。
总之，RT assay 是一种可靠的全血 EBV 载量检测方法。其灵敏度将能够估计 EBV 载量的动力学以及治疗控制 EBV 再激活的影响。
