Immunohematology and Transfusion Medicine Service, Fondazione IRCCS Istituto Nazionale dei Tumori (INT) di Milano, Milan, Italy.
Head and Neck Cancer Medical Oncology 3 Department, Fondazione IRCCS Istituto Nazionale dei Tumori (INT) di Milano, Milan, Italy.
Oral Oncol. 2022 Dec;135:106229. doi: 10.1016/j.oraloncology.2022.106229. Epub 2022 Nov 5.
Plasma Epstein-Barr Virus (EBV)-DNA is a well-established prognostic biomarker in nasopharyngeal carcinoma (NPC). Different methods for assessment include single-copy gene targeted, European Conformity (CE)-marked assays, which are mostly employed in non-endemic settings, vs multiple-copy gene targeted, in-house BamHI-W based assays, which currently represent the most widely used method for EBV-DNA quantification. To date, evidence concerning the commutability of these different assays is still limited.
From August 2016 to March 2018, 124 plasma and 124 whole blood (WB) samples from 93 NPC patients were collected at different time-points for each patient. EBV-DNA viral load was quantified in pre- (n = 12) and post-treatment (n = 9), follow-up (n = 53), and recurrent/metastatic (R/M) (n = 50) phase. For each sample, one in-house BamHI-W vs three different CE-marked plasma assays were compared; the performance of plasma vs WB matrix was also assessed. Quantitative agreement of EBV-DNA values was evaluated by linear correlation and Bland-Altman analysis.
A statistically significant (p = 0.0001) agreement between all CE-marked and the BamHI-W assays was found using plasma matrix, regardless of clinical phase. The results obtained in copies/ml were comparable to those expressed in IU/ml. When using WB matrix, the number of positive detections increased in the post-treatment phase.
Our retrospective comparison supported an agreement between Plasma BamHI-W and CE-marked assays in measuring EBV-DNA for non-endemic NPC patients. There were no significant interferences from different measurement units (IU/ml vs copies/ml). Further evaluations are needed to better clarify the role of WB.
血浆 Epstein-Barr 病毒（EBV）-DNA 是鼻咽癌（NPC）中一种成熟的预后生物标志物。不同的评估方法包括单拷贝基因靶向、欧洲符合性（CE）标记的检测方法，这些方法主要用于非流行地区，以及多拷贝基因靶向、基于 BamHI-W 的内部检测方法，目前代表了最广泛用于 EBV-DNA 定量的方法。迄今为止，关于这些不同检测方法可互换性的证据仍然有限。
从 2016 年 8 月至 2018 年 3 月，在不同时间点从 93 名 NPC 患者中收集了 124 份血浆和 124 份全血（WB）样本。在治疗前（n=12）、治疗后（n=9）、随访（n=53）和复发/转移（R/M）（n=50）期定量检测 EBV-DNA 病毒载量。对于每个样本，将一种内部 BamHI-W 与三种不同的 CE 标记的血浆检测方法进行比较；还评估了血浆与 WB 基质的性能。通过线性相关和 Bland-Altman 分析评估 EBV-DNA 值的定量一致性。
使用血浆基质，所有 CE 标记和 BamHI-W 检测方法之间均存在统计学显著（p=0.0001）的一致性，无论临床阶段如何。以拷贝/ml 表示的结果与以 IU/ml 表示的结果相当。当使用 WB 基质时，治疗后阶段的阳性检测数量增加。
我们的回顾性比较支持非流行地区 NPC 患者使用血浆 BamHI-W 和 CE 标记检测方法测量 EBV-DNA 的一致性。不同测量单位（IU/ml 与拷贝/ml）之间没有明显干扰。需要进一步评估以更好地阐明 WB 的作用。
