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Cited by 284Cervical Cancer and HPV ResearchWomen's cancer prevention and managementReproductive tract infections research

2020 list of human papillomavirus assays suitable for primary cervical cancer screening

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Arbyn, Marc, Simon, Marie, Peeters, Eliana, Xu, Lan, Meijer, Chris J.L.M., Berkhof, Johannes, Cuschieri, Kate, Bonde, Jesper +11 more·2021·Clinical Microbiology and Infection
DOI 10.1016/j.cmi.2021.04.031
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Abstract

BACKGROUND: Only clinically validated HPV assays can be accepted in cervical cancer screening. OBJECTIVES: To update the list of high-risk HPV assays that fulfil the 2009 international validation criteria (Meijer-2009). DATA SOURCES: PubMed/Medline, Embase, Scopus, references from selected studies; published in January 2014 to August 2020. STUDY ELIGIBILITY CRITERIA: HPV test validation studies and primary screening studies, involving testing with an index HPV test and a comparator HPV test with reporting of disease outcome (occurrence of histologically confirmed cervical precancer; CIN2+). PARTICIPANTS: Women participating in cervical cancer screening. INTERVENTIONS: Testing with an index and a comparator HPV test of clinician-collected cervical specimens and assessment of disease outcome (<CIN2, CIN2+). Comparator HPV assays were HC2, GP5+/6+ PCR-EIA, recommended in validation guidelines, or tests with consistent previous validations. METHODS: Assessment of relative clinical accuracy (including non-inferiority statistics index vs comparator assay) and test reproducibility in individual studies; random effects meta-analyses of the relative clinical sensitivity and specificity of index vs comparator tests. RESULTS: Seven hrHPV DNA tests consistently fulfilled all validation criteria in multiple studies using predefined test positivity cut-offs (Abbott RealTime High Risk HPV, Anyplex II HPV HR Detection, BD Onclarity HPV Assay, Cobas 4800 HPV Test, HPV-Risk Assay, PapilloCheck HPV-Screening Test and Xpert HPV). Another assay (Alinity m HR HPV Assay) was fully validated in one validation study. The newer Cobas 6800 HPV Test, was validated in two studies against Cobas 4800. Other tests partially fulfilled the international validation criteria (Cervista HPV HR Test, EUROArray HPV, Hybribio's 14 High-Risk HPV, LMNX Genotyping Kit GP HPV, MALDI-TOF, RIATOL qPCR and a number of other in-house developed assays) since the non-inferior accuracy was reached after a posteriori cut-off optimization, inconsistent accuracy findings in different studies, and/or insufficient reproducibility assessment. The APTIMA HPV Assay targeting E6/E7 mRNA of hrHPV was fully validated in one formal validation study and showed slightly lower pooled sensitivity but higher specificity than the standard comparator tests in seven screening studies. However, the current international validation criteria relate to DNA assays. The additional requirement for longitudinal performance data required for non-DNA based HPV assays was not assessed in this review. CONCLUSIONS: Eleven hrHPV DNA assays fulfil all requirements for use in cervical cancer screening using clinician-collected specimens.

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  • When Anyplex28 and Xpert HPV were evaluated against the GP5+/6+ EIA comparator HPV assay, sensitivity and specificity were 98.3% and 93.6% for Anyplex28, and 94.1% and 90.3% for Xpert HPV, respectively.

    “When Anyplex28 and Xpert HPV were evaluated against the GP5+/6 + EIA comparator HPV assay, sensitivity and specificity were 98.3% and 93.6% for Anyplex28, and 94.1%, and 90.3% for Xpert HPV, respectively [14, 15].”

    From Comparative analysis of SD biosensor standard™ M10 HPV and seegene anyplex™ II HPV HR for detecting high-risk human papillomavirus: a concordance study (2025) · cites this paper as [15]

    Table 2 reports the stated sensitivity and specificity figures for Xpert HPV and for Anyplex II HPV HR, using a GP5+/6+ comparator. The claim calls the latter assay “Anyplex28,” but the table does not identify the assay with those figures by that name. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • Cartridge-based POCTs may exhibit slightly lower agreement compared to laboratory-based assays.

    “These data suggest that cartridge-based POCTs may exhibit slightly lower agreement compared to laboratory-based assays [15].”

    From Comparative analysis of SD biosensor standard™ M10 HPV and seegene anyplex™ II HPV HR for detecting high-risk human papillomavirus: a concordance study (2025) · cites this paper as [15]

    Table 3 (page unavailable in our copy) reports 96.9% intra-laboratory reproducibility for Xpert HPV, below the values listed for several other assays. It does not establish that cartridge-based point-of-care tests generally have lower agreement than laboratory-based assays; Xpert's inter-laboratory reproducibility is also higher than that of some listed assays. (LLM, conf=0.78)

    Experimental — accuracy not yet measured

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Authors
Arbyn, M., Simon, M., Peeters, E., Xu, L., Meijer, C. J. L. M., Berkhof, J., Cuschieri, K., Bonde, J., Ostrbenk Vanlencak, A., Zhao, F.-H., Rezhake, R., Gultekin, M., Dillner, J., de Sanjosé, S., Canfell, K., Hillemanns, P., Almonte, M., Wentzensen, N., & Poljak, M.
Affiliations
  • Ghent University (BE)
  • Institut Scientifique de Santé Publique (BE)
  • Shanghai Jiao Tong University (CN)
  • Amsterdam University Medical Centers (NL)
  • Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
  • Edinburgh Royal Infirmary (GB)
  • Hvidovre Hospital (DK)
  • Xinjiang Medical University (CN)
  • Karolinska Institutet (SE)
  • The University of Sydney (AU)
  • Medizinische Hochschule Hannover (DE)
  • Centre international de recherche sur le cancer (FR)
  • National Cancer Institute (US)
  • University of Ljubljana (SI)
Corresponding author
Arbyn, Marc
ORCID
Venue
Clinical Microbiology and Infection
Publisher
Elsevier BV
Published
2021-08
Volume
27
Issue
8
Pages
1083-1095
ISSN
1198-743X (ISSN-L)
DOI
10.1016/j.cmi.2021.04.031
OpenAlex
W3161032360
Cited by
284
References
11
Citations by year
2026: 46 · 2025: 61 · 2024: 68 · 2023: 54 · 2022: 47 · 2021: 8
FWCI
6.77
Type
journal article
Language
en
Open access
Licence
Locations
  • Clinical Microbiology and Infection (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Ghent University Academic Bibliography (Ghent University) (submittedVersion, cc-by-nc-nd)
  • Amsterdam UMC (VU Amsterdam) - Institutional Repository (submittedVersion, other-oa)
  • Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
Funders
  • RIVM
  • German Cancer Aid
  • DG Research
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
cervical cancer screening, primary screening, high-risk HPV, assay validation, cervical intraepithelial neoplasia, CIN2+, cervical precancerous lesions
MeSH terms
Uterine Cervical Neoplasms, Female, Humans, Sensitivity and Specificity, Reproducibility of Results, Papillomaviridae, Papillomavirus Infections, Alphapapillomavirus, Early Detection of Cancer, Genotyping Techniques

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