Infection with multiple hepatitis C virus genotypes detected using commercial tests should be confirmed using next...

Area of Science:

• Hepatology
• Virology
• Molecular Diagnostics

Background:

• Accurate Hepatitis C virus (HCV) genotyping is crucial for treatment selection and epidemiological studies.
• Current HCV genotyping methods may exhibit limitations in detecting mixed-genotype infections, potentially impacting patient management.

Purpose of the Study:

• To evaluate the diagnostic accuracy of the Abbott-RealTime HCV Genotype II assay (Abbott-RT-PCR) for both single and mixed HCV infections.
• To compare the performance of Abbott-RT-PCR with a Roche Next-Generation Sequencing (NGS) assay for HCV genotyping.

Main Methods:

• Plasma samples from 139 HCV-infected patients were analyzed.
• Samples were initially genotyped using Abbott-RT-PCR and subsequently with Roche-NGS for comparison.
• Analysis focused on concordance rates for single and mixed HCV genotypes.

Main Results:

• Roche-NGS confirmed all single genotypes identified by Abbott-RT-PCR, with one discrepancy (Abbott GT 4 identified as GT 1a by NGS).
• Genotype 5 confirmation by NGS was 75% accurate.
• Concordance for mixed HCV infections between Abbott-RT-PCR and Roche-NGS was 76% (19/25), with significant discrepancies in three cases.

Conclusions:

• The Abbott-RT-PCR assay demonstrates excellent performance for identifying single HCV genotypes.
• For patients identified with mixed HCV infections by Abbott-RT-PCR, confirmatory testing using an NGS assay is recommended to ensure accurate diagnosis and appropriate clinical management.