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

doi:10.5501/wjv.v12.i4.233

Performance evaluation of NeuMoDx 96 system for hepatitis B and C viral load

World J Virol. 2023 Sep 25;12(4):233-241. doi: 10.5501/wjv.v12.i4.233.

Authors

Gagan Chooramani¹, Jasmine Samal¹, Nitiksha Rani¹, Gaurav Singh¹, Reshu Agarwal¹, Meenu Bajpai², Manoj Kumar³, Manya Prasad⁴, Ekta Gupta⁵

Affiliations

¹ Department of Clinical Virology, Institute of Liver & Biliary Sciences, New Delhi 110070, India.
² Department of Transfusion Medicine, Institute of Liver & Biliary Sciences, New Delhi 110070, India.
³ Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi 110070, India.
⁴ Department of Epidemiology and Clinical Research, Institute of Liver and Biliary Sciences, New Delhi 110070, India.
⁵ Department of Clinical Virology, Institute of Liver & Biliary Sciences, New Delhi 110070, India. ektagaurisha@gmail.com.

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: COBAS AmpliPrep; Hepatitis B; Hepatitis C; NeuMoDx; Random access; Viral load.