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Multicenter clinical evaluation of alinity m HCV assay performance
Stéphane Chevaliez1, Francesco Onelia2, Monia Pacenti3
1National Reference Center for Viral Hepatitis B, C, and D, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France; INSERM U955, Créteil, France.
Summary
The new Alinity m HCV assay accurately detects and quantifies Hepatitis C virus (HCV) RNA in patient samples. This sensitive and reproducible assay shows excellent performance across various genotypes, aiding in HCV diagnosis and treatment monitoring.
Area of Science:
- Virology
- Clinical Diagnostics
- Molecular Biology
Background:
- Nucleic acid testing is crucial for diagnosing Hepatitis C virus (HCV) infection and monitoring treatment efficacy.
- Abbott Molecular developed the Alinity m HCV assay for rapid HCV RNA detection and quantification on the automated Alinity m analyzer.
Purpose of the Study:
- To assess the performance of the Alinity m HCV assay for detecting and quantifying HCV RNA in a large cohort of patient samples.
- To evaluate the assay's linearity, precision, reproducibility, and comparative performance against existing clinical assays.
Main Methods:
- An international, multicentric study was conducted to evaluate the Alinity m HCV assay.
- Performance metrics including linearity, precision, and reproducibility were assessed.
- The assay's results were compared against three established HCV assays using serum and plasma samples.
Main Results:
- The Alinity m HCV assay demonstrated high linearity (r=1.00), precision (CV 6.6-13.5%), and reproducibility (CV 1.7-4.3%).
- Detectability exceeded 98% near the lower limit of detection.
- Excellent correlation (r≥0.96) was observed with comparator assays in serum and plasma samples.
Conclusions:
- The Alinity m HCV assay is a sensitive, reproducible, and accurate tool for quantifying HCV RNA in serum and plasma.
- Assay performance is consistent across different Hepatitis C virus genotypes.
- The assay is suitable for diagnosing and monitoring chronic HCV infection.
