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
ARTICLE HIGHLIGHTS
Research background

Large-scale prospective studies are needed to evaluate the overall analytical, clinical performance, and reproducibility of the NeuMoDx 96 system.

Research motivation

The findings of this study demonstrated excellent clinical performance (100% concordance) of the random access system compared to the conventional commercially available batch system. With a short turnaround time (TAT) and user-friendly operation, it is a reliable assay for hepatitis B virus (HBV) and hepatitis C virus (HCV) viral load (VL) ass-essment.

Research objectives

In this study, overall a good correlation (100% concordance) and agreement were found between the two systems for HBV DNA and HCV RNA VL quantification. The sensitivity and specificity of the NeuMoDx 96 for both HBV and HCV assays were found to be 100%. Moreover, no difference was found in the quantification of HBV/HCV VL across different genotypes.

Research methods

A total of 186 archived once-thawed plasma samples with pre-existing test results from initial routine lab testing were used. The overall concordance, correlation, and agreement were evaluated among all samples for HBV and HCV VL estimation using both systems.

Research results

The objectives of the study were: (1) Comparison of a random access system with conventional routinely used real-time PCR for quantifying HBV and HCV VL in plasma samples; (2) to estimate the overall concordance and agreement of VL quantification of clinical samples between the two systems; and (3) to evaluate genotype-based comparison of HBV and HCV VL between both systems.

Research conclusions

To date, most routinely used assays for HBV/HCV VL estimation typically run on batch testing. The use of such platforms across most of the diagnostic lab results in longer “sample-to-result” time, leading to loss to follow-up. Therefore, a reliable random access system with a shorter TAT is the need of the hour for all clinicians.

Research perspectives

HBV and HCV pose a significant health burden in low- and middle-income countries. The TAT for VL quantification (from receiving samples to giving out results) is longer for the conventional routinely used batch system-based real-time PCR assays. Therefore, to prevent loss to follow-up of a patient from the cascade of care, it is important to have molecular assays that are fully automated with high throughput and short TAT.