Real-world performance of the NeuMoDx™ HCV Quant Test for quantification of hepatitis C virus (HCV)-RNA

Nadine Lübke; Andreas Walker; Martin Obermeier; Jennifer Camdereli; Martha Paluschinski; Lara Walotka; Anna-Kathrin Schupp; Inga Tometten; Sandra Hauka; Eva Heger; Jörg Timm

doi:10.1016/j.jviromet.2024.114937

Real-world performance of the NeuMoDx™ HCV Quant Test for quantification of hepatitis C virus (HCV)-RNA

J Virol Methods. 2024 Apr 11:327:114937. doi: 10.1016/j.jviromet.2024.114937. Online ahead of print.

Authors

Affiliations

¹ Institute of Virology, National Reference Center for Hepatitis C viruses, Heinrich-Heine-University, University Hospital, Düsseldorf, Germany. Electronic address: nadine.luebke@med.uni-duesseldorf.de.
² Institute of Virology, National Reference Center for Hepatitis C viruses, Heinrich-Heine-University, University Hospital, Düsseldorf, Germany.
³ Medizinisches Infektiologiezentrum Berlin, Germany.
⁴ Institute for Virology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
⁵ Institute of Virology, University Hospital Cologne, University of Cologne, Cologne, Germany.

PMID: 38614281
DOI: 10.1016/j.jviromet.2024.114937

Abstract

Quantification of hepatitis C virus (HCV)-RNA in serum or plasma samples is an essential parameter in HCV diagnostics. Here, the NeuMoDx™Molecular System (Qiagen) was tested for the most common HCV genotypes and compared to the cobas c6800 system (Roche). HCV-RNA from 131 plasma/serum samples from chronically infected patients was determined in parallel on the NeuMoDx and c6800 systems. Linearity was analysed using the four most common HCV genotypes (1-4) in our cohort. The coefficient of variation (CV) within (intra-assay) and between (inter-assay) runs was calculated based on HCV-RNA concentration. Quantitative HCV-RNA results were highly correlated on both test systems (R² = 0.7947; y = 0.94 x + 0.37). On average, the NeuMoDx and c6800 HCV RNA levels showed a mean difference of only 0.05 log10 IU/mL but with a broad distribution (±1.2 2 x SD). The NeuMoDx demonstrated very good linearity across all HCV genotypes tested at concentrations between 1.7 and 6.2 log10 IU/mL (R² range: 0.9257-0.9991) with the highest mean coefficient of determination for genotype 1 (R² = 0.9909). The mean intra- and inter-assay CV for both serum and plasma samples was <5 %. The NeuMoDx HCV-RNA Assay demonstrates high subtype-independent comparability, linearity, and reproducibility for the quantification of HCV-RNA in serum and plasma samples from chronically infected patients.

Keywords: HCV; Linearity; NeuMoDx; Quantification; Real-world data; Reproducibility.