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Performance of the Xpert HBV Viral Load assay versus the Aptima Quant assay for quantifying hepatitis B virus DNA

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Title: Performance of the Xpert HBV Viral Load assay versus the Aptima Quant assay for quantifying hepatitis B virus DNA
Authors: Abravanel, Florence, Lhomme, Sébastien, Trémeaux, Pauline, Migueres, Marion, Harter, Agnès, Haslé, Catherine, Bruel, Patrick, Alric, Laurent, Métivier, Sophie, Raymond, Stéphanie, Izopet, Jacques
Contributors: Centre de Physiopathologie Toulouse Purpan (CPTP), Université Toulouse III - Paul Sabatier (UT3), Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Laboratoire Virologie CHU Toulouse, Institut Fédératif de Biologie (IFB), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle Biologie CHU Toulouse, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)
Source: ISSN: 0732-8893.
Publisher Information: CCSD
Elsevier
Publication Year: 2020
Collection: Université Toulouse III - Paul Sabatier: HAL-UPS
Subject Terms: Molecular diagnosis, Hepatitis B virus, GeneXpert instrument, MESH: DNA, Viral, MESH: Genotype, MESH: Sensitivity and Specificity, MESH: Viral Load / methods, MESH: Viral Load / standards, MESH: Workflow, MESH: Hepatitis B / diagnosis, MESH: Hepatitis B / virology, MESH: Hepatitis B virus / genetics, MESH: Humans, MESH: Molecular Diagnostic Techniques, MESH: Reproducibility of Results, [SDV]Life Sciences [q-bio]
Description: International audience ; Quantification of HBV DNA is used for initiating and monitoring antiviral treatment. We have evaluated the Xpert HBV Viral Load (VL) assay on the GeneXpert instrument. We estimated its limit of detection to be 7.5 IU/mL. Reproducibility was 1.1-12.7% as assessed by the coefficients of variation for 3 different samples. The assay was linear from 2 to 8 log10 IU/mL for HBV genotypes A to F. Its clinical performance was evaluated by testing prospectively 100 HBV DNA-positive samples with the Xpert HBV VL and Aptima Quant HBV assays. The results from the 2 assays were correlated, with a modest bias (-0.10 log10 IU/mL) between them by Bland-Altman analysis. Patient monitoring with 80 samples performed with both assays gave similar patient profiles with trends in the same direction. The Xpert HBV Viral load assay is reliable enough for quantifying HBV DNA in clinical practice.
Document Type: article in journal/newspaper
Language: English
Relation: info:eu-repo/semantics/altIdentifier/pmid/31771903; PUBMED: 31771903
DOI: 10.1016/j.diagmicrobio.2019.114946
Availability: https://hal.science/hal-03489830
https://hal.science/hal-03489830v1/document
https://hal.science/hal-03489830v1/file/S0732889319307679.pdf
https://doi.org/10.1016/j.diagmicrobio.2019.114946
Rights: https://creativecommons.org/licenses/by-nc/4.0/ ; info:eu-repo/semantics/OpenAccess
Accession Number: edsbas.79E383AA
Database: BASE
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  Data: Performance of the Xpert HBV Viral Load assay versus the Aptima Quant assay for quantifying hepatitis B virus DNA
– Name: Author
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  Data: <searchLink fieldCode="AR" term="%22Abravanel%2C+Florence%22">Abravanel, Florence</searchLink><br /><searchLink fieldCode="AR" term="%22Lhomme%2C+Sébastien%22">Lhomme, Sébastien</searchLink><br /><searchLink fieldCode="AR" term="%22Trémeaux%2C+Pauline%22">Trémeaux, Pauline</searchLink><br /><searchLink fieldCode="AR" term="%22Migueres%2C+Marion%22">Migueres, Marion</searchLink><br /><searchLink fieldCode="AR" term="%22Harter%2C+Agnès%22">Harter, Agnès</searchLink><br /><searchLink fieldCode="AR" term="%22Haslé%2C+Catherine%22">Haslé, Catherine</searchLink><br /><searchLink fieldCode="AR" term="%22Bruel%2C+Patrick%22">Bruel, Patrick</searchLink><br /><searchLink fieldCode="AR" term="%22Alric%2C+Laurent%22">Alric, Laurent</searchLink><br /><searchLink fieldCode="AR" term="%22Métivier%2C+Sophie%22">Métivier, Sophie</searchLink><br /><searchLink fieldCode="AR" term="%22Raymond%2C+Stéphanie%22">Raymond, Stéphanie</searchLink><br /><searchLink fieldCode="AR" term="%22Izopet%2C+Jacques%22">Izopet, Jacques</searchLink>
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  Data: Centre de Physiopathologie Toulouse Purpan (CPTP)<br />Université Toulouse III - Paul Sabatier (UT3)<br />Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Communauté d'universités et établissements de Toulouse (Comue de Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)<br />Laboratoire Virologie CHU Toulouse<br />Institut Fédératif de Biologie (IFB)<br />Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle Biologie CHU Toulouse<br />Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)
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  Data: <i>ISSN: 0732-8893</i>.
– Name: Publisher
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  Data: CCSD<br />Elsevier
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  Data: 2020
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  Data: Université Toulouse III - Paul Sabatier: HAL-UPS
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  Data: <searchLink fieldCode="DE" term="%22Molecular+diagnosis%22">Molecular diagnosis</searchLink><br /><searchLink fieldCode="DE" term="%22Hepatitis+B+virus%22">Hepatitis B virus</searchLink><br /><searchLink fieldCode="DE" term="%22GeneXpert+instrument%22">GeneXpert instrument</searchLink><br /><searchLink fieldCode="DE" term="%22MESH%3A+DNA%22">MESH: DNA</searchLink><br /><searchLink fieldCode="DE" term="%22Viral%22">Viral</searchLink><br /><searchLink fieldCode="DE" term="%22MESH%3A+Genotype%22">MESH: Genotype</searchLink><br /><searchLink fieldCode="DE" term="%22MESH%3A+Sensitivity+and+Specificity%22">MESH: Sensitivity and Specificity</searchLink><br /><searchLink fieldCode="DE" term="%22MESH%3A+Viral+Load+%2F+methods%22">MESH: Viral Load / methods</searchLink><br /><searchLink fieldCode="DE" term="%22MESH%3A+Viral+Load+%2F+standards%22">MESH: Viral Load / standards</searchLink><br /><searchLink fieldCode="DE" term="%22MESH%3A+Workflow%22">MESH: Workflow</searchLink><br /><searchLink fieldCode="DE" term="%22MESH%3A+Hepatitis+B+%2F+diagnosis%22">MESH: Hepatitis B / diagnosis</searchLink><br /><searchLink fieldCode="DE" term="%22MESH%3A+Hepatitis+B+%2F+virology%22">MESH: Hepatitis B / virology</searchLink><br /><searchLink fieldCode="DE" term="%22MESH%3A+Hepatitis+B+virus+%2F+genetics%22">MESH: Hepatitis B virus / genetics</searchLink><br /><searchLink fieldCode="DE" term="%22MESH%3A+Humans%22">MESH: Humans</searchLink><br /><searchLink fieldCode="DE" term="%22MESH%3A+Molecular+Diagnostic+Techniques%22">MESH: Molecular Diagnostic Techniques</searchLink><br /><searchLink fieldCode="DE" term="%22MESH%3A+Reproducibility+of+Results%22">MESH: Reproducibility of Results</searchLink><br /><searchLink fieldCode="DE" term="%22[SDV]Life+Sciences+[q-bio]%22">[SDV]Life Sciences [q-bio]</searchLink>
– Name: Abstract
  Label: Description
  Group: Ab
  Data: International audience ; Quantification of HBV DNA is used for initiating and monitoring antiviral treatment. We have evaluated the Xpert HBV Viral Load (VL) assay on the GeneXpert instrument. We estimated its limit of detection to be 7.5 IU/mL. Reproducibility was 1.1-12.7% as assessed by the coefficients of variation for 3 different samples. The assay was linear from 2 to 8 log10 IU/mL for HBV genotypes A to F. Its clinical performance was evaluated by testing prospectively 100 HBV DNA-positive samples with the Xpert HBV VL and Aptima Quant HBV assays. The results from the 2 assays were correlated, with a modest bias (-0.10 log10 IU/mL) between them by Bland-Altman analysis. Patient monitoring with 80 samples performed with both assays gave similar patient profiles with trends in the same direction. The Xpert HBV Viral load assay is reliable enough for quantifying HBV DNA in clinical practice.
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  Data: info:eu-repo/semantics/altIdentifier/pmid/31771903; PUBMED: 31771903
– Name: DOI
  Label: DOI
  Group: ID
  Data: 10.1016/j.diagmicrobio.2019.114946
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  Data: https://hal.science/hal-03489830<br />https://hal.science/hal-03489830v1/document<br />https://hal.science/hal-03489830v1/file/S0732889319307679.pdf<br />https://doi.org/10.1016/j.diagmicrobio.2019.114946
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