Retrospective Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Virol. Sep 25, 2023; 12(4): 233-241
Published online Sep 25, 2023. doi: 10.5501/wjv.v12.i4.233
Performance evaluation of NeuMoDx 96 system for hepatitis B and C viral load
Gagan Chooramani, Jasmine Samal, Nitiksha Rani, Gaurav Singh, Reshu Agarwal, Meenu Bajpai, Manoj Kumar, Manya Prasad, Ekta Gupta
Gagan Chooramani, Jasmine Samal, Nitiksha Rani, Gaurav Singh, Reshu Agarwal, Ekta Gupta, Department of Clinical Virology, Institute of Liver & Biliary Sciences, New Delhi 110070, India
Meenu Bajpai, Department of Transfusion Medicine, Institute of Liver & Biliary Sciences, New Delhi 110070, India
Manoj Kumar, Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi 110070, India
Manya Prasad, Department of Epidemiology and Clinical Research, Institute of Liver and Biliary Sciences, New Delhi 110070, India
Author contributions: Chooramani G contributed to the original manuscript draft writing and data curation; Samal J contributed to the data analyses and manuscript writing; Rani N contributed to the validation and data compilation; Singh G contributed to the validation and data compilation; Agarwal R contributed to the manuscript editing; Bajpai M contributed to the manuscript editing; Kumar M contributed to the clinical investigations; Prasad M contributed to the statistical analyses; Gupta E contributed to the conceptualization, supervision, and final manuscript editing; All authors read and approved the manuscript.
Institutional review board statement: The study was reviewed and approved by the Institutional Ethics Committee (IEC)/Institutional Review Board (IRB) of Institute of Liver and Biliary Sciences (Approval No. IEC/2023/102/MA06).
Informed consent statement: This was a retrospective study, so patient informed consent was waived.
Conflict-of-interest statement: The authors declare having no conflict of interest that pertains to this work.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Ekta Gupta, FRCPath (London), MBBS, MD, Professor, Department of Clinical Virology, Institute of Liver & Biliary Sciences, Vasant Kunj, New Delhi 110070, India. ektagaurisha@gmail.com
Received: June 21, 2023
Peer-review started: June 21, 2023
First decision: July 5, 2023
Revised: July 19, 2023
Accepted: August 7, 2023
Article in press: August 7, 2023
Published online: September 25, 2023
Abstract
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 (i.e. single sample) access are needed.

AIM

To evaluate the performance of the recently launched NeuMoDx 96 random access system with the conventional COBAS®AmpliPrep/COBAS TaqMan system for HBV and HCV VL estimation.

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

The median VL detected by NeuMoDx for HBV was 2.9 (interquartile range [IQR]: 2.0-4.3) log10 IU/mL and by COBAS it was 3.70 (IQR: 2.28-4.56) log10 IU/mL, with excellent correlation (R2 = 0.98). In HCV, the median VL detected by NeuMoDx was 4.9 (IQR: 4.2-5.4) log10 IU/mL and by COBAS it was 5.10 (IQR: 4.07-5.80) log10 IU/mL with good correlation (R2 = 0.96).

CONCLUSION

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.

Keywords: Hepatitis B, Hepatitis C, NeuMoDx, Random access, Viral load, COBAS AmpliPrep

Core Tip: In this study, the clinical performance of the NeuMoDx 96 random access system for hepatitis B virus (HBV) and hepatitis C virus (HCV) viral load (VL) quantification was evaluated and compared to the routinely used COBAS AmpliPrep/COBAS TaqMan system. Good concordance was observed between both systems for the HBV and HCV VL assays. Due to its random access (i.e. single sample access) characteristics and shorter turnaround, the NeuMoDx 96 can be considered a faster and effortless molecular testing system.