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