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NeuMoDx™ 平台用于巨细胞病毒和 Epstein-Barr 病毒病毒载量检测的分析和临床性能。

Analytical and Clinical Performance of the NeuMoDx™ Platform for Cytomegalovirus and Epstein-Barr Virus Viral Load Testing.

机构信息

Microbiology Department, Eastern Pathology Alliance, Norfolk and Norwich University Hospital NHS Foundation Trust, NRP Innovation Centre, Norwich Research Park, Colney, Norwich NR4 7GJ, UK.

出版信息

Viruses. 2024 Apr 25;16(5):671. doi: 10.3390/v16050671.

DOI:10.3390/v16050671
PMID:38793553
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11125657/
Abstract

DNA assays for viral load (VL) monitoring are key tools in the management of immunocompromised patients with cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection. In this study, the analytical and clinical performances of the NeuMoDx™ CMV and EBV Quant Assays were compared with artus CMV and EBV QS-RGQ Kits in a primary hospital testing laboratory. Patient plasma samples previously tested using artus kits were randomly selected for testing by NeuMoDx assays. The NeuMoDx CMV Quant Assay and artus CMV QS-RGQ Kit limits of detection (LoDs) are 20.0 IU/mL and 69.7 IU/mL, respectively; 33/75 (44.0%) samples had CMV DNA levels above the LoD of both assays. The Pearson correlation coefficient was 0.9503; 20 samples (60.6%) had lower NeuMoDx CMV quantification values versus the artus kit. The LoD of the NeuMoDx EBV Quant Assay and artus EBV QS-RGQ Kit are 200 IU/mL and 22.29 IU/mL, respectively; 16/75 (21.3%) samples had EBV DNA levels above the LoD of both assays. The Pearson correlation coefficient was 0.8990. EBV quantification values with the NeuMoDx assay were higher versus the artus kit in 15 samples (93.8%). In conclusion, NeuMoDx CMV and EBV Quant Assays are sensitive and accurate tools for CMV and EBV DNA VL quantification.

摘要

DNA 检测用于病毒载量(VL)监测是管理免疫功能低下的巨细胞病毒(CMV)或 Epstein-Barr 病毒(EBV)感染患者的关键工具。在本研究中,在一家主要医院检测实验室中,比较了 NeuMoDx™ CMV 和 EBV Quant 检测与 artus CMV 和 EBV QS-RGQ 试剂盒的分析和临床性能。使用 artus 试剂盒检测过的患者血浆样本随机选择用于 NeuMoDx 检测。NeuMoDx CMV Quant 检测和 artus CMV QS-RGQ 试剂盒的检测限(LoD)分别为 20.0 IU/mL 和 69.7 IU/mL;33/75(44.0%)样本的 CMV DNA 水平高于两种检测方法的 LoD。Pearson 相关系数为 0.9503;20 个样本(60.6%)的 NeuMoDx CMV 定量值低于 artus 试剂盒。NeuMoDx EBV Quant 检测和 artus EBV QS-RGQ 试剂盒的检测限分别为 200 IU/mL 和 22.29 IU/mL;16/75(21.3%)样本的 EBV DNA 水平高于两种检测方法的 LoD。Pearson 相关系数为 0.8990。在 15 个样本中(93.8%),NeuMoDx 检测的 EBV 定量值高于 artus 试剂盒。总之,NeuMoDx CMV 和 EBV Quant 检测是用于 CMV 和 EBV DNA VL 定量的敏感和准确的工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/686f/11125657/d1bc1fc7cd12/viruses-16-00671-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/686f/11125657/d1bc1fc7cd12/viruses-16-00671-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/686f/11125657/d1bc1fc7cd12/viruses-16-00671-g001.jpg

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2
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Cytomegalovirus Viral Load in Transplanted Patients Using the NeuMoDx™ (Qiagen) Automated System: A 1-Month Experience Feedback.使用 NeuMoDx™(Qiagen)自动化系统检测移植患者巨细胞病毒载量:1 个月经验反馈。
Viruses. 2021 Aug 16;13(8):1619. doi: 10.3390/v13081619.
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Pathogenesis of human cytomegalovirus in the immunocompromised host.免疫功能低下宿主中人巨细胞病毒的发病机制。
Nat Rev Microbiol. 2021 Dec;19(12):759-773. doi: 10.1038/s41579-021-00582-z. Epub 2021 Jun 24.
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Performance evaluation of the Roche cobas 6800 system for quantifying cytomegalovirus DNA in plasma and urine samples.罗氏 cobas 6800 系统用于定量检测血浆和尿液样本中巨细胞病毒 DNA 的性能评估。
J Clin Virol. 2021 May;138:104816. doi: 10.1016/j.jcv.2021.104816. Epub 2021 Mar 31.
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