Dokument: Real-world performance of the NeuMoDx™ HCV Quant Test for quantification of hepatitis C virus (HCV)-RNA
| Titel: | Real-world performance of the NeuMoDx™ HCV Quant Test for quantification of hepatitis C virus (HCV)-RNA | |||||||
| URL für Lesezeichen: | https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=68057 | |||||||
| URN (NBN): | urn:nbn:de:hbz:061-20250107-123509-5 | |||||||
| Kollektion: | Publikationen | |||||||
| Sprache: | Englisch | |||||||
| Dokumententyp: | Wissenschaftliche Texte » Artikel, Aufsatz | |||||||
| Medientyp: | Text | |||||||
| Autoren: | Lübke, Nadine [Autor] Walker, Andreas [Autor] Obermeier, Martin [Autor] Camdereli, Jennifer [Autor] Paluschinski, Martha [Autor] Walotka, Lara [Autor] Schupp, Anna-Kathrin [Autor] Tometten, Inga [Autor] Hauka, Sandra [Autor] Heger, Eva [Autor] | |||||||
| Dateien: |
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| Stichwörter: | Linearity, HCV, NeuMoDx, Reproducibility, Real-world data, Quantification | |||||||
| Beschreibung: | 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. | |||||||
| Rechtliche Vermerke: | Originalveröffentlichung:
Lübke, N., Walker, A., Obermeier, M., Camdereli, J., Paluschinski, M., Walotka, L., Schupp, A.-K., Tometten, I., Hauka, S., Heger, E., & Timm, J. (2024). Real-world performance of the NeuMoDxTM HCV Quant Test for quantification of hepatitis C virus (HCV)-RNA. Journal of Virological Methods, 327, Article 114937. https://doi.org/10.1016/j.jviromet.2024.114937 | |||||||
| Lizenz: |  Dieses Werk ist lizenziert unter einer Creative Commons Namensnennung 4.0 International Lizenz | |||||||
| Fachbereich / Einrichtung: | Medizinische Fakultät | |||||||
| Dokument erstellt am: | 07.01.2025 | |||||||
| Dateien geändert am: | 07.01.2025 |
