Which high-risk HPV assays fulfil criteria for use in primary cervical cancer screening?
Open accessAbstract
Several countries are in the process of switching to high-risk human papillomavirus (hrHPV) testing for cervical cancer screening. Given the multitude of available tests, validated assays which assure high-quality screening need to be identified. A systematic review was conducted to answer the question which hrHPV tests fulfil the criteria defined by an international expert team in 2009, based on reproducibility and relative sensitivity and specificity compared to Hybrid Capture-2 or GP5+/6+ PCR-enzyme immunoassay. These latter two hrHPV DNA assays were validated in large randomized trials and cohorts with a follow-up duration of 8 years or more. Eligible studies citing the 2009 guideline were retrieved from Scopus (http://www.scopus.com) and from a meta-analysis assessing the relative accuracy of new hrHPV assays versus the standard comparator tests to detect high-grade cervical intraepithelial neoplasia or cancer in primary screening. The cobas 4800 HPV test and Abbott RealTime High Risk HPV test were consistently validated in two and three studies, respectively, whereas the PapilloCheck HPV-screening test, BD Onclarity HPV assay and the HPV-Risk assay were validated each in one study. Other tests which partially fulfil the 2009 guidelines are the following: Cervista HPV HR Test, GP5+/6+ PCR-LMNX, an in-house E6/E7 RT quantitative PCR and MALDI-TOF (matrix-assisted laser desorption-ionization time-of-flight). The APTIMA HPV assay targeting E6/E7 mRNA of hrHPV was also fully…
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Several HPV assays have partially or completely been clinically validated using these criteria.
“Several HPV assays have partially or completely been clinically validated using these criteria [3].”
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 [3]
Anyplex II HPV HR Detection adds to some other validated assays that it directly provides genotyping data of 14 HR HPV types.
“Anyplex TM II HPV HR Detection adds to some other validated assays [3] that it directly provides genotyping data of 14 HR HPV types.”
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 [3]
Based on the findings, Anyplex II HPV HR Detection can be added to the list of HPV assays that fulfill the 2009 guidelines.
“Based on our findings, Anyplex TM II HPV HR Detection can be added to the list of HPV assays that fulfill the 2009 guidelines [3].”
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 [3]
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Self-citationComparing the performance of six human papillomavirus tests in a screening population
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Self-citationVALGENT: a protocol for clinical validation of human papillomavirus assays
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Assessment of the Roche Linear Array HPV Genotyping Test within the VALGENT framework
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- Authors
- Arbyn, M., Snijders, P. J. F., Meijer, C. J. L. M., Berkhof, J., Cuschieri, K., Kocjan, B. J., & Poljak, M.
- Affiliations
- Institut Scientifique de Santé Publique (BE)
- Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
- Edinburgh Royal Infirmary (GB)
- University of Ljubljana (SI)
- Corresponding author
- Arbyn, M.
- Venue
- Clinical Microbiology and Infection
- Publisher
- Elsevier BV
- Published
- 2015-09
- Volume
- 21
- Issue
- 9
- Pages
- 817-826
- ISSN
- 1198-743X (ISSN-L)
- OpenAlex
- W1998567451
- Cited by
- 275
- References
- 2
- Citations by year
- 2026: 8 · 2025: 5 · 2024: 20 · 2023: 15 · 2022: 21 · 2021: 27 · 2020: 28 · 2019: 36 · 2018: 37 · 2017: 21 · 2016: 39 · 2015: 17
- FWCI
- 29.82
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Microbiology and Infection (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- 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
- high-risk HPV testing, cervical cancer screening, assay validation, Hybrid Capture 2, Cobas 4800 HPV test, Aptima HPV assay, E6/E7 mRNA, high-grade cervical intraepithelial neoplasia, assay sensitivity and specificity, MALDI-TOF mass spectrometry, screening frequency
- MeSH terms
- Uterine Cervical Neoplasms, Female, Humans, Sensitivity and Specificity, Reproducibility of Results, Molecular Diagnostic Techniques, Papillomaviridae, Early Detection of Cancer, Genotyping Techniques
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