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Cited by 37Cervical Cancer and HPV ResearchClinical Laboratory Practices and Quality ControlReproductive tract infections research

Clinical and Analytical Performance of the BD Onclarity HPV Assay with SurePath Screening Samples from the Danish Cervical Screening Program Using the VALGENT Framework

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Bonde, Jesper Hansen, Pedersen, Helle, Quint, Wim, Xu, Lan, Arbyn, Marc, Ejegod, Ditte Møller·2020·Journal of Clinical Microbiology
DOI 10.1128/jcm.01518-19PMC PMC6989063
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Abstract

The Val idation of HPV Gen otyping T ests (VALGENT) framework is an international cooperation designed to evaluate human papillomavirus (HPV) assays with genotyping capabilities.

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Crossref · 10.1128/jcm.01518-19

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  • Clinical validation of Onclarity and Anyplex has been performed in previous studies according to international guidelines.

    “Although clinical validation of Onclarity and Anyplex has been performed in previous studies according to the international guidelines for human papillomavirus DNA testing [13–17]”

    From Comparison of Seegene Anyplex II HPV28 assay with BD Onclarity HPV assay for human papillomavirus genotyping (2022) · cites this paper as [13]

    The Discussion explicitly says that previous studies validated Onclarity using the international guidelines. The References list an Anyplex clinical evaluation within the VALGENT-3 framework, but our copy does not say that Anyplex was validated according to those international guidelines. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

  • Previous studies of these two assays using the non-inferiority test have validated their clinical performance for cervical cancer screening.

    “However, previous studies of these two assays using the non-inferiority test have validated their clinical performance for cervical cancer screening [13, 37].”

    From Comparison of Seegene Anyplex II HPV28 assay with BD Onclarity HPV assay for human papillomavirus genotyping (2022) · cites this paper as [13]

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Research works printed but not linked: 25

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  5. [8]Bonde J, Ejegod DM, Cuschieri K, Dillner J, Heideman DAM, Quint W, Pavon Ribas MA, Padalko E, Christiansen IK, Xu L, Arbyn M 2018 The Valgent4 protocol: robust analytical and clinical validation of 11 HPV assays with genotyping on cervical samples collected in SurePath medium. J Clin Virol 108: 64– 71. doi: 10.1016/j.jcv.2018.09.012. 30253376 · DOI · Paper page
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  7. [10]Schmitt M, Depuydt C, Benoy I, Bogers J, Antoine J, Arbyn M, Pawlita M, VALGENT Study Group. 2013 Multiple human papillomavirus infections with high viral loads are associated with cervical lesions but do not differentiate grades of cervical abnormalities. J Clin Microbiol 51: 1458– 1464. doi: 10.1128/JCM.00087-13. 23447632 PMC3647930 · DOI
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  9. [13]Cuschieri K, Geraets DT, Moore C, Quint W, Duvall E, Arbyn M 2015 Clinical and analytical performance of the Onclarity HPV assay using the VALGENT framework. J Clin Microbiol 53: 3272– 3279. doi: 10.1128/JCM.01366-15. 26246482 PMC4572536 · DOI
  10. [14]Geraets DT, Cuschieri K, de Koning MN, van Doorn LJ, Snijders PJ, Meijer CJ, Quint WG, Arbyn M 2014 Clinical evaluation of a GP5+/6+-based Luminex assay having full high-risk human papillomavirus genotyping capability and an internal control. J Clin Microbiol 52: 3996– 4002. doi: 10.1128/JCM.01962-14. 25210073 PMC4313237 · DOI
  11. [15]Heard I, Cuschieri K, Geraets DT, Quint W, Arbyn M 2016 Clinical and analytical performance of the PapilloCheck HPV-screening assay using the VALGENT framework. J Clin Virol 81: 6– 11. doi: 10.1016/j.jcv.2016.05.004. 27262102 · DOI
  12. [17]Polman NJ, Ostrbenk A, Xu L, Snijders PJF, Meijer C, Poljak M, Heideman DAM, Arbyn M 2017 Evaluation of the clinical performance of the HPV-Risk assay using the VALGENT-3 panel. J Clin Microbiol 55: 3544– 3551. doi: 10.1128/JCM.01282-17. 29021152 PMC5703818 · DOI
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  14. [20]Xu L, Padalko E, Ostrbenk A, Poljak M, Arbyn M 2018 Clinical evaluation of INNO-LiPA HPV Genotyping EXTRA II assay using the VALGENT framework. Int J Mol Sci 19: E2704. doi: 10.3390/ijms19092704. 30208597 PMC6165258 · DOI
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  24. [31]Steinau M, Patel SS, Unger ER 2011 Efficient DNA extraction for HPV genotyping in formalin-fixed, paraffin-embedded tissues. J Mol Diagn 13: 377– 381. doi: 10.1016/j.jmoldx.2011.03.007. 21704270 PMC3123789 · DOI
  25. [32]Agreda PM, Beitman GH, Gutierrez EC, Harris JM, Koch KR, LaViers WD, Leitch SV, Maus CE, McMillian RA, Nussbaumer WA, Palmer ML, Porter MJ, Richart GA, Schwab RJ, Vaughan LM 2013 Long-term stability of human genomic and human papillomavirus DNA stored in BD SurePath and Hologic PreservCyt liquid-based cytology media. J Clin Microbiol 51: 2702– 2706. doi: 10.1128/JCM.00759-13. 23678069 PMC3719621 · DOI

Cited by

Sorted by citations

Authors
Bonde, J. H., Pedersen, H., Quint, W., Xu, L., Arbyn, M., & Ejegod, D. M.
Affiliations
  • Copenhagen University Hospital (DK)
  • DDL Diagnostic Laboratory (NL)
  • Sciensano (Belgium) (BE)
Corresponding author
Bonde, Jesper Hansen
ORCID
Venue
Journal of Clinical Microbiology
Publisher
American Society for Microbiology
Published
2020-01-28
Volume
58
Issue
2
ISSN
  • 0095-1137 (ISSN-L)
  • 1098-660X
DOI
10.1128/jcm.01518-19
PMC
PMC6989063
OpenAlex
W2984664409
Cited by
37
References
5
Citations by year
2026: 1 · 2025: 9 · 2024: 3 · 2023: 4 · 2022: 10 · 2021: 8 · 2020: 2
FWCI
3.81
Type
journal article
Language
en
Open access
Licence
Locations
  • Journal of Clinical Microbiology (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
  • 7th Framework programme of DG Research and Innovation, European Commision (606019)
  • BD diagnostics
Topics
  • Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
Keywords
HPV genotyping, cervical cancer screening, sample storage stability, assay reproducibility
MeSH terms
Adult, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Cervix Uteri, Female, Genotype, Humans, Middle Aged, Sensitivity and Specificity, Molecular Diagnostic Techniques, Papillomavirus Infections, Alphapapillomavirus, Early Detection of Cancer, Genotyping Techniques

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