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Cited by 74Cervical Cancer and HPV ResearchWomen's cancer prevention and managementReproductive tract infections research

Disagreement between human papillomavirus assays: an unexpected challenge for the choice of an assay in primary cervical screening

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Rebolj, Matejka, Preisler, Sarah, Ejegod, Ditte Møller, Rygaard, Carsten, Lynge, Elsebeth, Bonde, Jesper·2014·PLoS ONE
DOI 10.1371/journal.pone.0086835PMC PMC3896484
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Abstract

We aimed to determine the disagreement in primary cervical screening between four human papillomavirus assays: Hybrid Capture 2, cobas, CLART, and APTIMA. Material from 5,064 SurePath samples of women participating in routine cervical screening in Copenhagen, Denmark, was tested with the four assays. Positive agreement between the assays was measured as the conditional probability that the results of all compared assays were positive given that at least one assay returned a positive result. Of all 5,064 samples, 1,679 (33.2%) tested positive on at least one of the assays. Among these, 41% tested positive on all four. Agreement was lower in women aged ≥ 30 years (30%, vs. 49% at <30 years), in primary screening samples (29%, vs. 38% in follow-up samples), and in women with concurrent normal cytology (22%, vs. 68% with abnormal cytology). Among primary screening samples from women aged 30-65 years (n = 2,881), 23% tested positive on at least one assay, and 42 to 58% of these showed positive agreement on any compared pair of the assays. While 4% of primary screening samples showed abnormal cytology, 6 to 10% were discordant on any pair of assays. A literature review corroborated our findings of considerable disagreement between human papillomavirus assays. This suggested that the extent of disagreement in primary screening is neither population- nor storage media-specific, leaving assay design differences as the most probable cause. The substantially different selection of women testing positive on the various human papillomavirus assays represents an unexpected challenge for the choice of an assay in primary cervical screening, and for follow up of in particular HPV positive/cytology normal women.

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Cited by

Sorted by citations

Authors
Rebolj, M., Preisler, S., Ejegod, D. M., Rygaard, C., Lynge, E., & Bonde, J.
Affiliations
  • University of Copenhagen (DK)
  • Hvidovre Hospital (DK)
Corresponding author
Rebolj, Matejka
ORCID
Venue
PLoS ONE
Publisher
Public Library of Science (PLoS)
Published
2014-01-20
Volume
9
Issue
1
Pages
e86835
ISSN
1932-6203 (ISSN-L)
DOI
10.1371/journal.pone.0086835
PMC
PMC3896484
OpenAlex
W2017599002
Cited by
74
References
2
Citations by year
2026: 2 · 2025: 2 · 2024: 5 · 2023: 1 · 2022: 7 · 2021: 6 · 2020: 2 · 2019: 6 · 2018: 6 · 2017: 7 · 2016: 12 · 2015: 12 · 2014: 5
FWCI
9.09
Type
journal article
Language
en
Open access
Licence
Locations
  • PLoS ONE (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Research Portal (King's College London) (submittedVersion, cc-by)
  • Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
Funders
  • Hvidovre Hospital
  • Strategic Research Council
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, HPV testing, assay agreement, test discordance, Hybrid Capture 2, cobas HPV test, SurePath, cytology, assay selection
MeSH terms
Adult, Aged, Biological Assay, Denmark, Female, Humans, Mass Screening, Middle Aged, Papillomaviridae, Papillomavirus Infections, Early Detection of Cancer, Young Adult

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