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

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
  • Additional Information
    • Source:
      Publisher: MDPI Country of Publication: Switzerland NLM ID: 101509722 Publication Model: Electronic Cited Medium: Internet ISSN: 1999-4915 (Electronic) Linking ISSN: 19994915 NLM ISO Abbreviation: Viruses Subsets: MEDLINE
    • Publication Information:
      Original Publication: Basel, Switzerland : MDPI
    • Subject Terms:
    • 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.
    • References:
      Haematologica. 2016 Jul;101(7):803-11. (PMID: 27365460)
      J Clin Microbiol. 2019 Dec 23;58(1):. (PMID: 31619529)
      Methods Mol Biol. 2014;1119:15-28. (PMID: 24639215)
      Virulence. 2020 Dec;11(1):964-967. (PMID: 32726172)
      J Clin Microbiol. 2016 Jun;54(6):1512-1519. (PMID: 27030491)
      Microbiol Spectr. 2022 Dec 21;10(6):e0215722. (PMID: 36342307)
      J Clin Microbiol. 2014 Oct;52(10):3802-4. (PMID: 25078918)
      Front Immunol. 2018 Jan 08;8:1902. (PMID: 29358936)
      Nat Rev Microbiol. 2021 Dec;19(12):759-773. (PMID: 34168328)
      J Clin Virol. 2022 Apr;149:105122. (PMID: 35299100)
      J Clin Microbiol. 2015 May;53(5):1500-5. (PMID: 25694529)
      N Engl J Med. 2000 Aug 17;343(7):481-92. (PMID: 10944566)
      Clin Transplant. 2019 Sep;33(9):e13512. (PMID: 30817026)
      BMC Fam Pract. 2019 May 14;20(1):62. (PMID: 31088382)
      J Clin Virol. 2021 May;138:104816. (PMID: 33836451)
      Clin Microbiol Rev. 2010 Jul;23(3):550-76. (PMID: 20610823)
      Viruses. 2021 Aug 16;13(8):. (PMID: 34452483)
      J Clin Virol. 2019 Apr;113:39-44. (PMID: 30870646)
      Clin Infect Dis. 2017 Jan 1;64(1):87-91. (PMID: 27682069)
      Virol J. 2010 Sep 22;7:252. (PMID: 20860842)
      Clin Infect Dis. 2016 Sep 1;63(5):583-9. (PMID: 27307504)
    • Grant Information:
      N/A QIAGEN Manchester Ltd.
    • Contributed Indexing:
      Keywords: DNA viral load monitoring; Epstein–Barr virus; NeuMoDx CMV Quant Assay; NeuMoDx EBV Quant Assay; cytomegalovirus; immune deficiency
    • Publication Date:
      Date Created: 20240525 Date Completed: 20240525 Latest Revision: 20240529
    • Publication Date:
      20240529
    • Accession Number:
      PMC11125657
    • Accession Number:
      10.3390/v16050671
    • Accession Number:
      38793553