Cited by 45Cervical Cancer and HPV ResearchWomen's cancer prevention and managementReproductive tract infections research

Assessment of the Roche Linear Array HPV Genotyping Test within the VALGENT framework

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

Abstract

Background Cervical cancer screening programs are switching from cytology-based screening to high-risk (hr) HPV testing. Only clinically validated tests should be used in clinical practice. Objectives To assess the clinical performance of the Roche Linear Array HPV genotyping test (Linear Array) within the VALGENT-3 framework. Study design The VALGENT framework is designed for comprehensive comparison and clinical validation of HPV tests that have limited to extended genotyping capacity. The Linear Array enables type-specific detection of 37 HPV types. For the purpose of this study, Linear Array results were designated as positive only if one of the 13 hrHPV types also included in the Hybrid Capture 2 (HC2) was detected. The VALGENT-3 framework comprised 1600 samples obtained from Slovenian women (1300 sequential cases from routine cervical cancer screening enriched with 300 cytological abnormal samples). Sensitivity for cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) (n=127) and specificity for Results The clinical sensitivity and specificity for CIN2+ of the Linear Array in the total study population was 97.6% (95% CI, 93.3-99.5%) and 91.7% (95% CI, 90.0-93.2%), respectively. The relative sensitivity and specificity of Linear Array vs HC2 was 1.02 [95% CI, 0.98-1.05, (p Conclusions Linear Array showed similar sensitivity with higher specificity to detect CIN2+ compared to HC2. Detection of 13 hrHPV types with Linear Array fulfils the clinical accuracy require…

Integrity signals

Registry

Crossref · 10.1016/j.jcv.2017.12.001

Cites

38 of 38 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Authors
Xu, L., Oštrbenk, A., Poljak, M., & Arbyn, M.
Affiliations
  • Institut Scientifique de Santé Publique (BE)
  • University of Ljubljana (SI)
Corresponding author
Arbyn, Marc
Venue
Journal of Clinical Virology
Publisher
Elsevier BV
Published
2018-01
Volume
98
Pages
37-42
ISSN
1386-6532 (ISSN-L)
OpenAlex
W2775678462
Cited by
45
References
38
Citations by year
2026: 3 · 2025: 1 · 2024: 3 · 2023: 4 · 2022: 6 · 2021: 9 · 2020: 6 · 2019: 9 · 2018: 4
FWCI
4.07
Type
journal article
Language
en
Open access
closed
Locations
  • Journal of Clinical Virology (publishedVersion)
  • PubMed (publishedVersion)
  • Ghent University Academic Bibliography (Ghent University) (submittedVersion)
Funders
DG Research of the European Commission (603019)
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, Hybrid Capture 2, HPV16, HPV 18, non-inferiority, cytology-based screening, Slovenian women
MeSH terms
Adult, Uterine Cervical Neoplasms, Cytological Techniques, Female, Genotype, Humans, Middle Aged, Sensitivity and Specificity, Papillomaviridae, Papillomavirus Infections, Early Detection of Cancer, Genotyping Techniques

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review