Cited by 692Cervical Cancer and HPV ResearchWomen's cancer prevention and managementReproductive tract infections research

Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older

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Meijer, Chris J.L.M., Berkhof, Johannes, Castle, Philip E., Hesselink, Albertus T., Franco, Eduardo L., Ronco, Guglielmo, Arbyn, Marc, Bosch, F. Xavier +4 more·2009·International Journal of Cancer

Abstract

Given the strong etiologic link between high‐risk HPV infection and cervical cancer high‐risk HPV testing is now being considered as an alternative for cytology‐based cervical cancer screening. Many test systems have been developed that can detect the broad spectrum of hrHPV types in one assay. However, for screening purposes the detection of high‐risk HPV is not inherently useful unless it is informative for the presence of high‐grade cervical intraepithelial neoplasia (CIN 2/3) or cancer. Candidate high‐risk HPV tests to be used for screening should reach an optimal balance between clinical sensitivity and specificity for detection of high‐grade CIN and cervical cancer to minimize redundant or excessive follow‐up procedures for high‐risk HPV positive women without cervical lesions. Data from various large screening studies have shown that high‐risk HPV testing by hybrid capture 2 and GP5+/6+‐PCR yields considerably better results in the detection of CIN 2/3 than cytology. The data from these studies can be used to guide the translation of high‐risk HPV testing into clinical practice by setting standards of test performance and characteristics. On the basis of these data we have developed guidelines for high‐risk HPV test requirements for primary cervical screening and validation guidelines for candidate HPV assays. © 2008 Wiley‐Liss, Inc.

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  • Clinically validated high-performance molecular tests like hrHPV DNA tests that meet established international performance criteria, such as those defined by Meijer et al and verified through the VALGENT framework, are recommended.

    “Key recommendations emphasize the use of clinically validated high-performance molecular tests like hrHPV deoxyribonucleic acid (DNA) tests that meet established international performance criteria, such as those defined by Meijer et al and verified through the VALGENT framework.”

    From Integrating a “see-and-treat” approach with opportunistic human papilloma virus deoxyribonucleic acid (HPV DNA) based cervical cancer screening in India: a retrospective cross-sectional study (2026) · cites this paper as [11]

    The Requirements and Validation guidelines sections (page not available) define clinical-performance criteria for hrHPV tests in primary screening of women aged at least 30 and recommend validating candidate tests against a clinically validated reference test. The paper describes its guidelines as a proposal seeking international consensus; our copy does not say the criteria were verified through the VALGENT framework. (LLM, conf=0.88)

    Experimental — accuracy not yet measured
  • The see-and-treat model achieved a sensitivity of 0.98 and specificity of 0.91, meeting international clinical validation criteria and WHO targets for appropriate management.

    “Our “see-and-treat” model (Figure 3) achieved a sensitivity of 0.98 and specificity of 0.91, meeting international clinical validation criteria11 and WHO targets for appropriate management.8”

    From Integrating a “see-and-treat” approach with opportunistic human papilloma virus deoxyribonucleic acid (HPV DNA) based cervical cancer screening in India: a retrospective cross-sectional study (2026) · cites this paper as [11]

    The “Validation guidelines for candidate HPV assays” section sets clinical validation criteria for HPV DNA tests in women aged 30 and older, including sensitivity and specificity relative to the hc2 reference test. It does not evaluate the citing authors’ see-and-treat model or establish that its reported sensitivity of 0.98 and specificity of 0.91 meet those comparative criteria. The WHO-target portion is attached to a different citation. (LLM, conf=0.86)

    Experimental — accuracy not yet measured
  • The guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women of 30 years and older are widely accepted and used to validate HPV assays.

    “Currently, “Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women of 30 years and older” [21] are widely accepted and used to validate HPV assays.”

    From Comparison of Seegene Anyplex II HPV28 assay with BD Onclarity HPV assay for human papillomavirus genotyping (2022) · cites this paper as [21]

    The “Validation guidelines for candidate HPV assays” section sets out criteria for validating HPV tests, supporting the identification of this paper as a source of validation guidelines. But the “Laboratory guidelines for HPV testing” section calls them a proposal intended to achieve international consensus; it does not establish that they were already widely accepted or widely used to validate assays. Page numbers are unavailable in our copy. (LLM, conf=0.86)

    Experimental — accuracy not yet measured
  • Anyplex II HPV HR Detection complies with international consensus validation metrics for HPV DNA tests for cervical cancer screening.

    “Anyplex TM II HPV HR Detection complies with international consensus validation metrics for HPV DNA tests for cervical cancer screening [1].”

    From Clinical validation of Anyplex™ II HPV HR Detection according to the guidelines for HPV test requirements for cervical cancer screening (2016) · cites this paper as [1]

    The ‘Validation guidelines for candidate HPV assays’ section sets criteria for HPV tests used in cervical screening, including reproducibility and inter-laboratory agreement. The paper identifies hc2 and GP5+/6+-PCR EIA as meeting its requirements, but it does not assess Anyplex II HPV HR Detection or establish that it complies with them. Page numbers are unavailable in our copy. (LLM, conf=0.85)

    Experimental — accuracy not yet measured
  • Both intra-laboratory reproducibility and inter-laboratory agreement fulfilled the validation metrics, with lower confidence bound of percentage of agreement >87% and kappa >0.5.

    “Both the intra-laboratory reproducibility over time and the inter-laboratory agreement fulfilled the validation metrics given a lower confidence bound of percentage of agreement that was higher than 87%, and a corresponding kappa value that was higher than 0.5 [1].”

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Research works printed but not linked: 32

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Authors
Meijer, C. J. L. M., Berkhof, J., Castle, P. E., Hesselink, A. T., Franco, E. L., Ronco, G., Arbyn, M., Bosch, F. X., Cuzick, J., Dillner, J., Heideman, D. A. M., & Snijders, P. J. F.
Affiliations
  • Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
  • McGill University (CA)
  • Institut Scientifique de Santé Publique (BE)
  • Institut Català d'Oncologia (ES)
  • Queen Mary University of London (GB)
  • Lund University (SE)
Corresponding author
Meijer, Chris J.L.M.
Venue
International Journal of Cancer
Publisher
Wiley
Published
2008-10-30
Volume
124
Issue
3
Pages
516-520
ISSN
  • 0020-7136 (ISSN-L)
  • 1097-0215
OpenAlex
W1996007109
Cited by
692
References
0
Citations by year
2026: 25 · 2025: 29 · 2024: 52 · 2023: 40 · 2022: 45 · 2021: 33 · 2020: 37 · 2019: 41 · 2018: 44 · 2017: 33 · 2016: 34 · 2015: 40 · 2014: 49 · 2013: 46 · 2012: 45
FWCI
24.33
Type
journal article
Language
en
Open access
Locations
  • International Journal of Cancer (publishedVersion)
  • PubMed (publishedVersion)
  • Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • Digital Academic REpository of VU University Amsterdam (Vrije Universiteit Amsterdam) (submittedVersion)
  • Lund University Publications (Lund University) (submittedVersion)
  • Pure Amsterdam UMC (submittedVersion)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
Funders
National Institutes of Health (Z99 CA999999)
Topics
  • Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
  • Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
Keywords
human papillomavirus, high-risk HPV testing, cervical cancer screening, primary screening, Hybrid Capture 2, cervical intraepithelial neoplasia, assay validation, sensitivity and specificity, cytology comparison
MeSH terms
Adult, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Female, Humans, Mass Screening, Sensitivity and Specificity, Polymerase Chain Reaction, Guidelines as Topic, Papillomavirus Infections

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