Published online Sep 25, 2023. doi: 10.5501/wjv.v12.i4.233
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
Processing time: 90 Days and 1 Hours
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.
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.
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) 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).
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.
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.