{"title":"Performance evaluation of NeuMoDx 96, a random access system for CMV DNA quantitation","authors":"Priyanka Sharma , Ekta Gupta , Guresh Kumar , Bhawna Narula , Gaurav Singh , Reshu Agarwal","doi":"10.1016/j.diagmicrobio.2025.116746","DOIUrl":null,"url":null,"abstract":"<div><div>Cytomegalovirus (CMV) poses a significant risk to immunocompromised individuals, particularly in post-transplant settings, leading to substantial morbidity and occasional mortality. Early and accurate quantification of CMV DNA is essential for timely intervention. This retrospective study evaluated the performance of the NeuMoDx 96 platform, a random-access CMV assay, compared to the COBAS® AmpliPrep/COBAS® TaqMan® CMV assay, a batch testing platform. Using 104 archived once thawed plasma samples and the WHO International Standard for CMV, the NeuMoDx assay demonstrated 98.2 % sensitivity, 100 % specificity, and 99.04 % diagnostic accuracy compared to the COBAS® assay. Excellent concordance was observed with the WHO standard. These findings suggest that the NeuMoDx 96 platform offers a cost-effective and rapid method for CMV detection, potentially improving clinical decision-making in critically ill patients. Further research on similar assays across diverse clinical settings is essential to enhance the early diagnosis and treatment of CMV infections.</div></div>","PeriodicalId":11329,"journal":{"name":"Diagnostic microbiology and infectious disease","volume":"112 1","pages":"Article 116746"},"PeriodicalIF":2.1000,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diagnostic microbiology and infectious disease","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0732889325000690","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 0
Abstract
Cytomegalovirus (CMV) poses a significant risk to immunocompromised individuals, particularly in post-transplant settings, leading to substantial morbidity and occasional mortality. Early and accurate quantification of CMV DNA is essential for timely intervention. This retrospective study evaluated the performance of the NeuMoDx 96 platform, a random-access CMV assay, compared to the COBAS® AmpliPrep/COBAS® TaqMan® CMV assay, a batch testing platform. Using 104 archived once thawed plasma samples and the WHO International Standard for CMV, the NeuMoDx assay demonstrated 98.2 % sensitivity, 100 % specificity, and 99.04 % diagnostic accuracy compared to the COBAS® assay. Excellent concordance was observed with the WHO standard. These findings suggest that the NeuMoDx 96 platform offers a cost-effective and rapid method for CMV detection, potentially improving clinical decision-making in critically ill patients. Further research on similar assays across diverse clinical settings is essential to enhance the early diagnosis and treatment of CMV infections.
期刊介绍:
Diagnostic Microbiology and Infectious Disease keeps you informed of the latest developments in clinical microbiology and the diagnosis and treatment of infectious diseases. Packed with rigorously peer-reviewed articles and studies in bacteriology, immunology, immunoserology, infectious diseases, mycology, parasitology, and virology, the journal examines new procedures, unusual cases, controversial issues, and important new literature. Diagnostic Microbiology and Infectious Disease distinguished independent editorial board, consisting of experts from many medical specialties, ensures you extensive and authoritative coverage.