Unité des Virus Émergents (UVE), Aix-Marseille Université, IRD 190-Inserm 1207, 13005 Marseille, France.
Laboratoire de Microbiologie, Assistance Publique-Hôpitaux de Marseille, IHU Méditerranée Infection, 13005 Marseille, France.
Viruses. 2021 Aug 16;13(8):1619. doi: 10.3390/v13081619.
Cytomegalovirus (CMV) reactivations represent a significant morbidity and mortality problem in transplant patients. Reliable and rapid measurement of CMV viral load is a key issue for optimal patient management. We report here the evaluation of NeuMoDx™ (Qiagen) in a routine hospital setting (University Hospitals of Marseille, France) in comparison with our classical reference technique R-GENE. During one month, 719 CMV viral loads from 507 patients were measured in parallel in both techniques. Using the ROC (receiver operating characteristic) curve and our biological experience we suggest that values <52 IU/mL (geometric mean) correspond to negative samples, values >140 IU/mL (Fowlkes-Mallows index) correspond to quantifiable positive results and values ranging from 52 to 140 IU/mL represent non-quantifiable positive results. Follow-up of 15 transplant patients who developed CMV reactivation during the study showed that NeuMoDx™ provided higher viral load measurement during the first two weeks of follow-up for three patients. These important intra-individual variations resulted in a significant median increase considering the whole data set (6.7 points of difference expressed as a percentage of the initial viral load). However, no difference between the two techniques was noticeable after two weeks of treatment. Subsequent to this first study we conclude that NeuMoDx™, used with optimized logistics and an adapted threshold, allows a rapid CMV viral load measurement and that its use does not lead to any difference in patient management compared to the reference technique R-GENE.
巨细胞病毒 (CMV) 再激活是移植患者发病率和死亡率高的一个重要原因。可靠和快速的 CMV 病毒载量测量是优化患者管理的关键问题。我们在此报告了在常规医院环境（法国马赛大学附属医院）中使用 NeuMoDx™（Qiagen）与我们的经典参考技术 R-GENE 进行的评估。在一个月的时间里，同时使用这两种技术对 507 名患者的 719 份 CMV 病毒载量进行了平行测量。使用 ROC（受试者工作特征）曲线和我们的生物学经验，我们建议 <52 IU/mL（几何平均值）的值对应于阴性样本，>140 IU/mL（Fowlkes-Mallows 指数）的值对应于可量化的阳性结果，而 52 至 140 IU/mL 的值则代表不可量化的阳性结果。对 15 名在研究期间发生 CMV 再激活的移植患者进行随访发现，NeuMoDx™ 在随访的前两周内为三名患者提供了更高的病毒载量测量值。这些重要的个体内差异导致整个数据集的中位数显著增加（以初始病毒载量的百分比表示为 6.7 点差异）。然而，在两周的治疗后，两种技术之间没有差异。在这项初步研究之后，我们得出结论，NeuMoDx™ 可用于快速测量 CMV 病毒载量，使用优化的物流和适应的阈值，并且与参考技术 R-GENE 相比，其使用不会导致患者管理的任何差异。
