Multicenter clinical evaluation of alinity m HCV assay performance.

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
Stéphane ChevaliezRory Gunson

Abstract

Nucleic acid testing is essential for the detection and quantification of HCV RNA in the diagnosis of HCV infection and treatment monitoring. The Alinity m HCV assay was recently developed by Abbott Molecular for rapid detection and quantification of HCV RNA on the fully automated, continuous, random-access Alinity m analyzer. Our study assessed the performance of the new Alinity m HCV assay for detection and quantification of HCV RNA in a large series of patient samples of various genotypes. This international, multicentric study evaluated the linearity, precision, and reproducibility of the Alinity m HCV assay and its performance in comparison to three other HCV assays currently used in clinical practice. The Alinity m HCV assay demonstrated high linearity (correlation coefficient r = 1.00), precision (coefficients of variation [CV] 6.6-13.5 %) and reproducibility (CV 1.7-4.3 % across three control lots). At a concentration near the lower limit of detection, the Alinity m HCV assay exhibited >98 % detectability. The Alinity m HCV assay showed excellent correlation with comparator HCV assays in serum (n = 406) and plasma (n = 1401) samples (correlation coefficients ≥0.96, bias 0.01 to 0.14 Log10 IU/mL). More than 95 % of the q...Continue Reading

Citations

Mar 18, 2021·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Layla Testa GalindoJosé Eduardo Levi
May 24, 2021·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Garrett A PerchettiAlexander L Greninger
Jun 11, 2021·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Valérie OrtonneStéphane Chevaliez
Jun 15, 2021·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Olivia GarrigouStéphane Chevaliez

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