title: Multicenter Evaluation of the Cepheid Xpert Hepatitis C Virus Viral Load Assay.
abstract: Viral load monitoring for hepatitis C virus (HCV) is necessary to diagnose infection and monitor response to therapy, but the tests involved are currently confined to specialist institutions. There is a need for a fast, accurate assay with limited operator input to enhance the access to viral load monitoring. We evaluated the quantification of HCV RNA in serum and plasma by the Cepheid Xpert HCV Viral Load assay in comparison to the Abbott RealTime HCV assay. Serum and plasma samples were gathered from HCV-infected individuals at four international sites. These were tested with the Xpert HCV Viral Load assay, and results were compared to quantification by the Abbott RealTime HCV assay. An external quality assessment panel of eight samples was also tested. In total, 614 samples were analyzed in the study, and the qualitative results agreed on the two platforms for 588 (95.8%) samples. Further analysis of 396 samples quantified by both tests showed strong correlation (correlation coefficientr= 0.99) across the quantifiable range, with Bland-Altman plot data showing a mean difference (±1.96 standard deviation) of 0.03 ± 0.44 log10IU/ml. In the external quality assessment panel, the Xpert HCV Viral Load assay results (quantified in log10IU per milliliter) were within 1 standard deviation of the target value for all but one sample, which was also similarly misquantified by the Abbott RealTime HCV assay. The Xpert HCV Viral Load assay performs well compared to a market-leading HCV viral load test and should be considered for instances where rapid near-to-patient testing is required.
authors.affiliation: Specialist Virology Centre, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.
authors.forename: M P
authors.identifier: 0000-0002-0370-3700
authors.initials: MP
authors.lastname: McHugh
authors.affiliation: Department of Laboratory Medicine, University of California, San Francisco, San Francisco, California, USA.
authors.forename: A H B
authors.initials: AHB
authors.lastname: Wu
authors.affiliation: National Reference Center for Viral Hepatitis B, C and delta, Department of Virology, Henri Mondor Hospital, Créteil, France.
authors.forename: S
authors.initials: S
authors.lastname: Chevaliez
authors.affiliation: National Reference Center for Viral Hepatitis B, C and delta, Department of Virology, Henri Mondor Hospital, Créteil, France.
authors.forename: J M
authors.initials: JM
authors.lastname: Pawlotsky
authors.affiliation: Center for Molecular Diagnostics, Laboratoire Hospitalier Universitaire de Bruxelles, Brussels, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Hallin
authors.affiliation: Specialist Virology Centre, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom Kate.Templeton@nhslothian.scot.nhs.uk.
authors.forename: K E
authors.initials: KE
authors.lastname: Templeton
mesh_terms: D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics; D019562:Viral Load / Q000379:methods*
chemical_list: D012367:RNA, Viral
keywords: HCV RNA; hepatitis C virus; viral load