Performance evaluation of NeuMoDx 96 system for hepatitis B and C viral load.
COBAS AmpliPrep
Hepatitis B
Hepatitis C
NeuMoDx
Random access
Viral load
Journal
World journal of virology
ISSN: 2220-3249
Titre abrégé: World J Virol
Pays: United States
ID NLM: 101608353
Informations de publication
Date de publication:
25 Sep 2023
25 Sep 2023
Historique:
received:
21
06
2023
revised:
19
07
2023
accepted:
07
08
2023
medline:
16
11
2023
pubmed:
16
11
2023
entrez:
16
11
2023
Statut:
ppublish
Résumé
Hepatitis B virus (HBV) and hepatitis C virus (HCV) viral load (VL) estimation is essential for the management of both HBV and HCV infections. Due to a longer turnaround time for VL estimation, many patients drop out from the cascade of care. To achieve the global goals of reducing morbidity and mortality due to HBV/HCV and moving towards their elimination by 2030, molecular diagnostic platforms with faster and random ( To evaluate the performance of the recently launched NeuMoDx 96 random access system with the conventional COBAS Archived once-thawed plasma samples were retrieved and tested on both platforms. Correlation between the assays was determined by linear regression and Bland-Altman analysis. The study included samples from 186 patients, 99 for HBV of which 49 were true infected HBV cases (hepatitis B surface antigen, anti-hepatitis B core antibody, and HBV DNA-positive) and 87 for HCV assay in which 39 were true positives for HCV infection (anti-HCV and HCV RNA-positive). The median VL detected by NeuMoDx for HBV was 2.9 (interquartile range [IQR]: 2.0-4.3) log The overall concordance between both the systems was 100% for both HBV and HCV VL estimation. Moreover, no genotype-specific bias for HBV/HCV VL quantification was seen in both the systems. Our findings reveal that NeuMoDx HBV and HCV quantitative assays have shown overall good clinical performance and provide faster results with 100% sensitivity and specificity compared to the COBAS AmpliPrep/COBAS TaqMan system.
Sections du résumé
BACKGROUND
BACKGROUND
Hepatitis B virus (HBV) and hepatitis C virus (HCV) viral load (VL) estimation is essential for the management of both HBV and HCV infections. Due to a longer turnaround time for VL estimation, many patients drop out from the cascade of care. To achieve the global goals of reducing morbidity and mortality due to HBV/HCV and moving towards their elimination by 2030, molecular diagnostic platforms with faster and random (
AIM
OBJECTIVE
To evaluate the performance of the recently launched NeuMoDx 96 random access system with the conventional COBAS
METHODS
METHODS
Archived once-thawed plasma samples were retrieved and tested on both platforms. Correlation between the assays was determined by linear regression and Bland-Altman analysis. The study included samples from 186 patients, 99 for HBV of which 49 were true infected HBV cases (hepatitis B surface antigen, anti-hepatitis B core antibody, and HBV DNA-positive) and 87 for HCV assay in which 39 were true positives for HCV infection (anti-HCV and HCV RNA-positive).
RESULTS
RESULTS
The median VL detected by NeuMoDx for HBV was 2.9 (interquartile range [IQR]: 2.0-4.3) log
CONCLUSION
CONCLUSIONS
The overall concordance between both the systems was 100% for both HBV and HCV VL estimation. Moreover, no genotype-specific bias for HBV/HCV VL quantification was seen in both the systems. Our findings reveal that NeuMoDx HBV and HCV quantitative assays have shown overall good clinical performance and provide faster results with 100% sensitivity and specificity compared to the COBAS AmpliPrep/COBAS TaqMan system.
Identifiants
pubmed: 37970568
doi: 10.5501/wjv.v12.i4.233
pmc: PMC10642378
doi:
Types de publication
Journal Article
Langues
eng
Pagination
233-241Informations de copyright
©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
Déclaration de conflit d'intérêts
Conflict-of-interest statement: The authors declare having no conflict of interest that pertains to this work.
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