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Virology

European Multicenter Study on Analytical Performance of Veris HIV-1 Assay

Patrick Braun, Rafael Delgado, Monica Drago, Diana Fanti, Hervé Fleury, Jörg Hofmann, Jacques Izopet, Ulrich Kalus, Alessandra Lombardi, Maria Angeles Marcos, Davide Mileto, Karine Sauné, Siobhan O'Shea, Alfredo Pérez-Rivilla, John Ramble, Pascale Trimoulet, Jordi Vila, Duncan Whittaker, Alain Artus, Daniel W. Rhodes
Angela M. Caliendo, Editor
Patrick Braun
aLaboratory Dr. Knechten, Medical Center for HIV and Hepatitis, Aachen, Germany
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Rafael Delgado
bMicrobiology Department, Hospital Universitario 12 de Octubre and Insituto de Investigation, Hospital 12 de Octubre (i+12), Madrid, Spain
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Monica Drago
cClinical Chemistry and Microbiology Laboratories, Niguarda Ca' Granda Hospital, Milan, Italy
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Diana Fanti
cClinical Chemistry and Microbiology Laboratories, Niguarda Ca' Granda Hospital, Milan, Italy
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Hervé Fleury
dVirology Department, Hôpital Pellegrin, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France
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Jörg Hofmann
eVirology Department, Labor Berlin—Charité Vivantes GmbH, Berlin, Germany
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Jacques Izopet
fDepartment of Virology, Federative Institute of Biology, Centre Hospitalier Universitaire (CHU) de Toulouse, Toulouse, France
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Ulrich Kalus
gInstitute of Transfusion Medicine, Charité—Universitätsmedizin, Berlin, Germany
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Alessandra Lombardi
hClinical Microbiology, Virology and Bioemergence Diagnosis, L. Sacco University Hospital, Milan, Italy
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Maria Angeles Marcos
iDepartment of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research (CRESIB), Barcelona, Spain
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Davide Mileto
hClinical Microbiology, Virology and Bioemergence Diagnosis, L. Sacco University Hospital, Milan, Italy
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Karine Sauné
fDepartment of Virology, Federative Institute of Biology, Centre Hospitalier Universitaire (CHU) de Toulouse, Toulouse, France
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Siobhan O'Shea
jViapath Analytics, Infection Sciences, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom
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Alfredo Pérez-Rivilla
bMicrobiology Department, Hospital Universitario 12 de Octubre and Insituto de Investigation, Hospital 12 de Octubre (i+12), Madrid, Spain
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John Ramble
jViapath Analytics, Infection Sciences, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom
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Pascale Trimoulet
dVirology Department, Hôpital Pellegrin, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France
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Jordi Vila
iDepartment of Clinical Microbiology, Hospital Clinic, School of Medicine, University of Barcelona, Centre for International Health Research (CRESIB), Barcelona, Spain
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Duncan Whittaker
kLaboratory Medicine Building, Northern General Hospital, Sheffield, United Kingdom
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Alain Artus
lBeckman Coulter, Immunotech, Marseille, France
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Daniel W. Rhodes
lBeckman Coulter, Immunotech, Marseille, France
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Angela M. Caliendo
Rhode Island Hospital
Roles: Editor
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DOI: 10.1128/JCM.00078-17
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ABSTRACT

The analytical performance of the Veris HIV-1 assay for use on the new, fully automated Beckman Coulter DxN Veris molecular diagnostics system was evaluated at 10 European virology laboratories. The precision, analytical sensitivity, performance with negative samples, linearity, and performance with HIV-1 groups/subtypes were evaluated. The precision for the 1-ml assay showed a standard deviation (SD) of 0.14 log10 copies/ml or less and a coefficient of variation (CV) of ≤6.1% for each level tested. The 0.175-ml assay showed an SD of 0.17 log10 copies/ml or less and a CV of ≤5.2% for each level tested. The analytical sensitivities determined by probit analysis were 19.3 copies/ml for the 1-ml assay and 126 copies/ml for the 0.175-ml assay. The performance with 1,357 negative samples demonstrated 99.2% with not detected results. Linearity using patient samples was shown from 1.54 to 6.93 log10 copies/ml. The assay performed well, detecting and showing linearity with all HIV-1 genotypes tested. The Veris HIV-1 assay demonstrated analytical performance comparable to that of currently marketed HIV-1 assays. (DxN Veris products are Conformité Européenne [CE]-marked in vitro diagnostic products. The DxN Veris product line has not been submitted to the U.S. FDA and is not available in the U.S. market. The DxN Veris molecular diagnostics system is also known as the Veris MDx molecular diagnostics system and the Veris MDx system.)

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European Multicenter Study on Analytical Performance of Veris HIV-1 Assay
Patrick Braun, Rafael Delgado, Monica Drago, Diana Fanti, Hervé Fleury, Jörg Hofmann, Jacques Izopet, Ulrich Kalus, Alessandra Lombardi, Maria Angeles Marcos, Davide Mileto, Karine Sauné, Siobhan O'Shea, Alfredo Pérez-Rivilla, John Ramble, Pascale Trimoulet, Jordi Vila, Duncan Whittaker, Alain Artus, Daniel W. Rhodes
Journal of Clinical Microbiology Jun 2017, 55 (7) 2055-2063; DOI: 10.1128/JCM.00078-17

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European Multicenter Study on Analytical Performance of Veris HIV-1 Assay
Patrick Braun, Rafael Delgado, Monica Drago, Diana Fanti, Hervé Fleury, Jörg Hofmann, Jacques Izopet, Ulrich Kalus, Alessandra Lombardi, Maria Angeles Marcos, Davide Mileto, Karine Sauné, Siobhan O'Shea, Alfredo Pérez-Rivilla, John Ramble, Pascale Trimoulet, Jordi Vila, Duncan Whittaker, Alain Artus, Daniel W. Rhodes
Journal of Clinical Microbiology Jun 2017, 55 (7) 2055-2063; DOI: 10.1128/JCM.00078-17
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    • ABSTRACT
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KEYWORDS

Automation, Laboratory
HIV Infections
HIV-1
Molecular Diagnostic Techniques
analytical performance
HIV-1 RNA quantification
Veris HIV-1 assay

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