Mourik K, Boers S A, van Rijn A L, Thijssen J C P, Doorn R, Svraka S, Bart A, Wessels E, Claas E C J, Nijhuis R H T
Department of Medical Microbiology, Leiden University Medical Center, Leiden, the Netherlands.
Department of Medical Microbiology, Leiden University Medical Center, Leiden, the Netherlands.
J Clin Virol. 2022 Apr;149:105122. doi: 10.1016/j.jcv.2022.105122. Epub 2022 Feb 26.
The detection and follow up of cytomegalovirus (CMV) and Epstein-Barr virus (EBV) viral loads (VL) are crucial in the management of immunocompromised patients. Recently, molecular CE-IVD assays for detection and quantification of CMV and EBV have been launched for use on the random-access and sample-to-result NeuMoDx 96 and 288 platforms (Qiagen).
Evaluating the qualitative and quantitative performance of the NeuMoDx CMV and EBV assays in clinical specimens compared to a lab developed tests (LDT) and the CE-IVD assays on the Abbott m2000 system.
Both a prospective and a retrospective panel, compiled of non-detectable (ND), non-quantifiable (NQ) and quantifiable VLs in plasma samples have been evaluated for both CMV and EBV: NeuMoDx versus LDT and NeuMoDx versus Abbott m2000. Quantitative agreement was determined for samples with a quantifiable VL on both systems.
Qualitative and quantitative agreement between the NeuMoDx and LUMC's LDT CMV assays was 88%. Qualitative agreement between the NeuMoDx and Abbott m2000 CMV assays was 92% and quantitative agreement was 87%. Qualitative and quantitative agreement between the NeuMoDx and the LDT EBV assays was 87%. Qualitative agreement between the NeuMoDx and Abbott m2000 EBV assays was 91% and quantitative agreement was 0%.
These data show that the NeuMoDx assays are suitable for both detection and quantification of CMV and EBV in a medium- to high throughput diagnostic setting, but that differences in sensitivity and quantification (for EBV, NeuMoDx versus Abbott m2000) warrant an extensive transition period when using the respective assays for following VL in patient samples.
巨细胞病毒（CMV）和爱泼斯坦-巴尔病毒（EBV）病毒载量（VL）的检测及随访对于免疫功能低下患者的管理至关重要。最近，用于检测和定量CMV及EBV的分子CE-IVD检测方法已在随机存取和样本到结果的NeuMoDx 96和288平台（Qiagen）上推出。
与实验室开发的检测方法（LDT）以及雅培m2000系统上的CE-IVD检测方法相比，评估NeuMoDx CMV和EBV检测方法在临床标本中的定性和定量性能。
针对CMV和EBV，对由血浆样本中不可检测（ND）、不可定量（NQ）和可定量的VL组成的前瞻性和回顾性样本组进行了评估：NeuMoDx与LDT以及NeuMoDx与雅培m2000。确定了两个系统上具有可定量VL的样本的定量一致性。
NeuMoDx与LUMC的LDT CMV检测方法之间的定性和定量一致性为88%。NeuMoDx与雅培m2000 CMV检测方法之间的定性一致性为92%，定量一致性为87%。NeuMoDx与LDT EBV检测方法之间的定性和定量一致性为87%。NeuMoDx与雅培m2000 EBV检测方法之间的定性一致性为91%，定量一致性为0%。
这些数据表明，NeuMoDx检测方法适用于中到高通量诊断环境中CMV和EBV的检测和定量，但在使用各自检测方法对患者样本中的VL进行随访时，灵敏度和定量方面的差异（对于EBV，NeuMoDx与雅培m2000相比）需要一个漫长的过渡期。
