Assessment of the Roche Linear Array HPV Genotyping Test within the VALGENT framework
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…
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The Linear Array assay is capable of detecting 37 HPV genotypes.
“This assay is capable of detecting 37 genotypes and consists of a PCR followed by in situ hybridization and subsequent reading on a nylon strip coated with HPV type-specific and human beta-globin-specific oligonucleotide probes [15].”
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“This assay is capable of detecting 37 genotypes and consists of a PCR followed by in situ hybridization and subsequent reading on a nylon strip coated with HPV type-specific and human beta-globin-specific oligo-nucleotide probes [15].”
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- 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.
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