Evaluation of the Fluorion HCV QNP v3.0 real-time PCR assay for quantifying HCV RNA in Moroccan patients: A comparative study with COBAS AmpliPrep/COBAS TaqMan HCV v2.0

IF 1 Q4 GENETICS & HEREDITY Gene Reports Pub Date : 2024-08-06 DOI:10.1016/j.genrep.2024.102004

Salma Madihi , Samia Boukaira , Hind Bouafi , Warda Baha , Bouchra Belkadi , Abdelouaheb Benani

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Abstract

Purpose

Hepatitis C Virus (HCV) RNA quantification is crucial for diagnosing and monitoring chronic HCV treatment. Cost-effective methods are crucial to ensure accessibility. This study evaluated the Fluorion HCV QNP v3.0 Real-Time PCR assay's effectiveness in EDTA-plasma and serum, comparing it with the COBAS AmpliPrep/COBAS TaqMan HCV v2.0 (CAP/CTM HCV v2.0) test.

Methods

105 matched pairs of EDTA-plasma and serum specimens (91 positive and 14 negative) from HCV infected Moroccan patients were analyzed using the Fluorion HCV QNP v3.0 assay and compared to the CAP/CTM HCV v2.0 test, being the reference method.

Results

The values obtained by the Fluorion HCV QNP v3.0 in plasma were slightly higher than those in serum (3.94 ± 2.23 log₁₀ IU/mL versus 3.91 ± 2.22 log₁₀ IU/mL) and were both significantly lower than those quantified by the CAP/CTM HCV v2.0 assay (4.34 ± 2.28 log₁₀ IU/mL; p < 0.001). High correlations were observed between the Fluorion HCV QNP v3.0 serum and CAP/CTM HCV v2.0 (R² = 0.9433), the Fluorion HCV QNP v3.0 plasma and CAP/CTM HCV v2.0 (R² = 0.949) and the Fluorion HCV QNP v3.0 serum and plasma (R² = 0.9954). HCV RNA was detected in all tested genotypes by both assays.

Conclusion

The Fluorion HCV QNP v3.0 assay demonstrated excellent performance in comparison with the CAP/CTM HCV v2.0 on both plasma and serum samples which can be used interchangeably for HCV quantification. The test was shown to be suitable for disease monitoring including all HCV genotypes.

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对 Fluorion HCV QNP v3.0 实时 PCR 检测摩洛哥患者 HCV RNA 定量的评估：与 COBAS AmpliPrep/COBAS TaqMan HCV v2.0 的比较研究

目的丙型肝炎病毒（HCV）RNA 定量对于诊断和监测慢性 HCV 治疗至关重要。经济有效的方法对于确保可及性至关重要。本研究评估了 Fluorion HCV QNP v3.0 Real-Time PCR 检测法在 EDTA 血浆和血清中的有效性，并将其与 COBAS AmpliPrep/COBAS TaqMan HCV v2.0 (CAP/CTM HCV v2.0) 检测法进行了比较。结果Fluorion HCV QNP v3.0在血浆中获得的值略高于血清（3.94 ± 2.23 log10 IU/mL对3.91 ± 2.22 log10 IU/mL），且均显著低于CAP/CTM HCV v2.0检测的定量值（4.34 ± 2.28 log10 IU/mL；p <0.001）。Fluorion HCV QNP v3.0血清与CAP/CTM HCV v2.0（R2 = 0.9433）、Fluorion HCV QNP v3.0血浆与CAP/CTM HCV v2.0（R2 = 0.949）以及Fluorion HCV QNP v3.0血清与血浆（R2 = 0.9954）之间存在高度相关性。结论与 CAP/CTM HCV v2.0 相比，Fluorion HCV QNP v3.0 检测法在血浆和血清样本中表现出卓越的性能，可互换用于 HCV 定量。该检测适用于包括所有 HCV 基因型在内的疾病监测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Gene Reports Biochemistry, Genetics and Molecular Biology-Genetics

CiteScore

3.30

自引率

7.70%

发文量

246

审稿时长

49 days

期刊介绍： Gene Reports publishes papers that focus on the regulation, expression, function and evolution of genes in all biological contexts, including all prokaryotic and eukaryotic organisms, as well as viruses. Gene Reports strives to be a very diverse journal and topics in all fields will be considered for publication. Although not limited to the following, some general topics include: DNA Organization, Replication & Evolution -Focus on genomic DNA (chromosomal organization, comparative genomics, DNA replication, DNA repair, mobile DNA, mitochondrial DNA, chloroplast DNA). Expression & Function - Focus on functional RNAs (microRNAs, tRNAs, rRNAs, mRNA splicing, alternative polyadenylation) Regulation - Focus on processes that mediate gene-read out (epigenetics, chromatin, histone code, transcription, translation, protein degradation). Cell Signaling - Focus on mechanisms that control information flow into the nucleus to control gene expression (kinase and phosphatase pathways controlled by extra-cellular ligands, Wnt, Notch, TGFbeta/BMPs, FGFs, IGFs etc.) Profiling of gene expression and genetic variation - Focus on high throughput approaches (e.g., DeepSeq, ChIP-Seq, Affymetrix microarrays, proteomics) that define gene regulatory circuitry, molecular pathways and protein/protein networks. Genetics - Focus on development in model organisms (e.g., mouse, frog, fruit fly, worm), human genetic variation, population genetics, as well as agricultural and veterinary genetics. Molecular Pathology & Regenerative Medicine - Focus on the deregulation of molecular processes in human diseases and mechanisms supporting regeneration of tissues through pluripotent or multipotent stem cells.