Performances of NeuMoDx™, a random-access system for hepatitis B virus DNA and hepatitis C virus RNA quantification

Abstract

Objective: Monitoring of viral loads (VL) for hepatitis B and C viruses (HBV; HCV) is essential to evaluate disease progression and treatment response. Automated, random-access rapid systems are becoming standard to provide clinicians with reliable VL. The aim of this study was to evaluate the analytical performances of the recently launched NeuMoDx™ for HBV-DNA and HCV-RNA quantification. Methods: Clinical samples routinely quantified on the BeckmaneVeris system were either retrospectively (frozen samples; HBV n ¼ 178, HCV n ¼ 249), or in parallel (fresh primary tubes; HBV n ¼ 103, HCV n ¼ 117) tested using NeuMoDx™. Linearity range was assessed on serial dilutions of high-titre plasmas containing different genotypes for HBV (AeE, n ¼ 9) and HCV (1a,1b,2e5, n ¼ 12). Results: Overall test failure, mostly internal control amplification failure, was 2.3% and was not influenced by matrix types (fresh or frozen). For HBV VL, k agreement was 74%, with 27 (12.6%) discrepancies.Correlation between HBV assays on 72 quantified samples by both methods was excellent (r ¼ 0.963) with a mean bias (NeuMoDx™eVeris) of 0.21 log IU/mL. For HCV VL, k agreement reached 94%, with 9(2.8%) discrepancies. The r correlation factor between assays on 104 samples was 0.960 with a mean bias of e0.14 log IU/mL (NeuMoDx™eVeris). Serial dilutions confirmed the claimed linear ranges for all analysed HBV and HCV genotypes. The mean turnaround time was 72 minutes (range 55e101 minutes) for HBV and 96 minutes (range 78e133 minutes) for HCV. Conclusion:Results obtained on the NeuMoDx™ confirmed the overall good functionality of the system with a short turn-around-time, full traceability and easy handling. These results on HBV and HCV VL look promising and should be challenged with further comparisons.

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

“…Limited studies regarding the evaluation of the NeuMoDx platform are available. Our study focused on its real-life evaluation on clinical samples[ 19 - 21 ].…”