Cited by 34Cervical Cancer and HPV ResearchReproductive tract infections researchClinical Laboratory Practices and Quality Control

Clinical and Analytical Evaluation of the Anyplex II HPV HR Detection Assay within the VALGENT-3 Framework

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Oštrbenk, Anja, Xu, Lan, Arbyn, Marc, Poljak, Mario·2018·Journal of Clinical Microbiology

Abstract

In 2012, VALidation of human papillomavirus (HPV) GENotyping Tests (VALGENT) was initiated to provide a formalized and uniform study framework for comparison and validation of HPV assays with genotyping capability. In VALGENT-3, the clinical and analytical performance of Anyplex II HPV HR detection (Anyplex) was compared to that of the Hybrid Capture 2 HPV DNA test (hc2) and the cobas 4800 HPV test (cobas).

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Crossref · 10.1128/jcm.01176-18

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  • The Anyplex assay has reported sensitivities ranging from 92.5 to 98.3% and specificities from 81.7 to 94.1% for detecting CIN2+.

    “For example, the Anyplex assay has been reported with sensitivities ranging from 92.5 to 98.3% and specificities from 81.7 to 94.1% for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) [16, 17, 18].”

    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 [18]

    The Discussion (page unavailable) reports CIN2+ sensitivities of 92.5% and 98.3% from earlier Anyplex studies, and Results Table 1 reports 94.1% specificity in women aged ≥30. Neither passage supports the claimed 81.7% lower specificity bound; a search for 81.7% found no matching result in our copy. (LLM, conf=0.88)

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Authors
Oštrbenk, A., Xu, L., Arbyn, M., & Poljak, M.
Affiliations
  • University of Ljubljana (SI)
  • Sciensano (Belgium) (BE)
Venue
Journal of Clinical Microbiology
Published
2018-11
Volume
56
Issue
11
ISSN
  • 0095-1137 (ISSN-L)
  • 1098-660X
OpenAlex
W2889838499
Cited by
34
References
47
Citations by year
2026: 4 · 2025: 3 · 2024: 3 · 2023: 2 · 2022: 3 · 2021: 9 · 2020: 3 · 2019: 7
FWCI
3.71
Type
journal article
Language
en
Open access
Locations
  • Journal of Clinical Microbiology (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
European Commission (603019)
Topics
  • Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
  • Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Keywords
human papillomavirus, HPV genotyping, Hybrid Capture 2, Cobas 4800 HPV test, assay validation, analytical performance, clinical performance, HPV testing
MeSH terms
Adult, Uterine Cervical Neoplasms, Cervix Uteri, Female, Genotype, Humans, Middle Aged, Sensitivity and Specificity, Reproducibility of Results, Slovenia, Papillomaviridae, Papillomavirus Infections, Early Detection of Cancer, Genotyping Techniques

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