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Cited by 33Cervical Cancer and HPV ResearchReproductive tract infections researchWomen's cancer prevention and management

Clinical performance of Anyplex II HPV28 by human papillomavirus type and viral load in a referral population.

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Baasland, Ingrid, Romundstad, Pål R., Eide, Maj Liv, Jonassen, Christine M.·2019·PLOS ONE
DOI 10.1371/journal.pone.0210997PMC PMC6343909
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Abstract

Anyplex II HPV28 (`Anyplex`) is a semi-quantitative DNA PCR assay divided into set A, comprising 14 high risk (hr)HPV types; and set B, comprising 5 possibly hrHPV types and 9 low risk (lr)HPV types. We compared the ability of Anyplex to that of Hybrid Capture 2 (HC2) and PreTect HPV-Proofer (`Proofer`) to detect cervical intraepithelial neoplasia grade two or worse (CIN2+) by HPV types and viral load. This cross-sectional study included 296 women referred to colposcopy with abnormal cervical cytology and/or persistent HPV infection. CIN2+ was identified in 175/296 women. Liquid based cytology samples were used to perform HPV testing. The sensitivity of Anyplex to detect CIN2+ was 98.9% (95% CI 95.9-99.9) and specificity 43.0% (95% CI 34.0-52.3). Restricting to medium and high viral loads in Anyplex set A, sensitivity and specificity were 97.1% (95% CI 93.5-99.1) and 59.5% (95% CI 50.2-68.3) with positive (PPV) and negative predictive value (NPV) 77.6% and 93.5%, respectively, comparable to HC2. Restricting Anyplex to the hrHPV types in Proofer, HPV16, 18, 31, 33 and 45, sensitivity and specificity for CIN2+ were 85.1% (95% CI 79.0-90.1) and 71.1% (95% CI 62.1-79.0), comparable to Proofer`s. When adding HPV52 and 58, the sensitivity for CIN2+ was 92.6% (95% CI 87.6-96.0) and CIN3+ 96.5% (95% CI 92.0-98.8). No value of Anyplex set B was found in detecting CIN2+. In conclusion, the clinical performance of medium and high viral loads in Anyplex set A was comparable to HC2. Restricting the test to the 7 hrHPV types included in the 9-valent HPV-vaccine, HPV16, 18, 31, 33, 45, 52 and 58, satisfies the international criteria for cervical cancer screening with relative sensitivity compared to HC2 for CIN2+ and CIN3+ of 0.98 and 1.01, respectively. Detecting all 28 Anyplex HPV types adds no benefit in a referral population.

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  • The Seegene Anyplex II HPV28 assay is designed to detect 14 hrHPV types, five possible hrHPV types, and nine low-risk HPV types.

    “It has been specifically designed to simultaneously detect 14 hrHPV types (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), five possible hrHPV types (HPV26, 53, 69, 73, and 82), and nine low-risk (lr)HPV types (HPV 6, 11, 40, 42, 43, 44, 53, 54, and 70) [12].”

    From Comparison of Seegene Anyplex II HPV28 assay with BD Onclarity HPV assay for human papillomavirus genotyping (2022) · cites this paper as [12]

    The Materials and methods > HPV testing passage confirms that Anyplex II HPV28 detects 14 hrHPV types, five possible hrHPV types, and nine low-risk types, and its first two type lists match the citing sentence. The citing sentence’s low-risk list does not match: it names HPV53, which the paper lists as a possible hrHPV type, and omits low-risk HPV61. (LLM, conf=0.94)

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References 31 · Cited by 33

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Authors
Baasland, I., Romundstad, P. R., Eide, M. L., & Jonassen, C. M.
Affiliations
  • Norwegian University of Science and Technology (NO)
  • St Olav's University Hospital (NO)
  • Østfold Hospital Trust (NO)
Corresponding author
Baasland, Ingrid
ORCID
Venue
PLOS ONE
Publisher
Public Library of Science (PLoS)
Published
2019-01-23
Volume
14
Issue
1
Pages
e0210997
ISSN
1932-6203 (ISSN-L)
DOI
10.1371/journal.pone.0210997
PMC
PMC6343909
OpenAlex
W2914455690
Cited by
33
References
31
Citations by year
2026: 1 · 2025: 5 · 2024: 7 · 2023: 5 · 2022: 6 · 2021: 3 · 2020: 3 · 2019: 3
FWCI
2.85
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)
  • NORA - Norwegian Open Research Archives (submittedVersion, cc-by)
Funders
Helse Midt-Norge
Topics
  • Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
  • Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
Keywords
high-risk HPV, HPV viral load, cervical intraepithelial neoplasia, CIN2+ detection, Hybrid Capture 2, HPV genotyping, HPV16, HPV 18, HPV 31, HPV 33, HPV45, HPV52, HPV58, liquid-based cytology
MeSH terms
Adult, Aged, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Cervix Uteri, Cross-Sectional Studies, DNA, Viral, Female, Humans, Middle Aged, Norway, Predictive Value of Tests, Sensitivity and Specificity, Prevalence, Polymerase Chain Reaction, Viral Load, Papillomaviridae, Papillomavirus Infections, Young Adult

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