Evidence map›Paper›PMID 39588720›Full record

ArticleJournal of medical virology2024

Clinical Performance of OncoPredict HPV Screening Assay on Self-Collected Vaginal and Urine Specimens Within the VALHUDES Framework.

Chiara Giubbi, Marianna Martinelli, Ardashel Latsuzbaia, Kate Cuschieri, Hana Elasifer, Anna Daniela Iacobone, Fabio Bottari, Andrea Fausto Piana, Roberto Pietri, Giancarlo Tisi and 4 more

Abstract readEvaluation Study
In one paragraph

Article in Journal of medical virology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Chiara GiubbiSchool of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.ORCID 0000-0001-6112-7572
Marianna MartinelliSchool of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.ORCID 0000-0003-2273-6986
Ardashel LatsuzbaiaUnit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.ORCID 0000-0002-7361-3081
Kate CuschieriScottish HPV Reference Laboratory, Department of Lab Medicine Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.ORCID 0000-0002-2604-3928
Hana ElasiferScottish HPV Reference Laboratory, Department of Lab Medicine Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, UK.
Anna Daniela IacobonePreventive Gynecology Unit, European Institute of Oncology IRCCS, Milan, Italy.ORCID 0000-0001-6909-1228
Fabio BottariGeneral Clinical Laboratory with Specialized Areas Clinical Pathology - Microbiology and Virology, European Institute of Oncology IRCCS, Milan, Italy.ORCID 0000-0003-1838-0163
Andrea Fausto PianaDepartment of Medicine, Surgery and Pharmacy, University of Sassari, Sassari, Italy.
Roberto PietriU.O. Coordinamento Consultori Familiari, ASSL Sassari - ATS Sardegna, Sassari, Italy.
Giancarlo TisiGynecologic and Obstetrical Division, University of Brescia-Spedali Civili di Brescia, Brescia, Italy.
Franco OdicinoGynecologic and Obstetrical Division, University of Brescia-Spedali Civili di Brescia, Brescia, Italy.ORCID 0000-0001-8870-4739
Marc ArbynUnit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.ORCID 0000-0001-7807-5908
Clementina Elvezia CocuzzaSchool of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.ORCID 0000-0001-6166-1134
European VALHUDES Working Group

Funding

This research was funded by the Horizon 2020 SME Instrument and Horizon 2020 Framework Programme.
6 · The paper itself

Abstract

The introduction of self-sampling in cervical cancer screening has raised the importance of HPV test validation on self-collected samples. This study aimed to evaluate the clinical accuracy of the OncoPredict HPV Screening (SCR) assay on self-collected vaginal and first-void urine (FVU) samples, relative to cervical specimens, using the VALHUDES Framework. FVU and vaginal self-samples followed by a clinician-collected cervical brushing were collected from 500 women referred to colposcopy and tested using OncoPredict HPV SCR assay. The assay demonstrated clinical sensitivity to detect cervical intraepithelial neoplasia grade 2 or worse (≥ CIN2) similar to cervical samples in FVU (ratio: 0.95, [95% CI: 0.88-1.02]) and vaginal self-samples (ratio: 0.96 [95% CI: 0.90-1.02]). The clinical specificity for < CIN2 was lower in vaginal (ratio: 0.90 [95% CI: 0.84-0.96]) but not in FVU samples (ratio: 1.03 [95% CI: 0.96-1.12) when compared to cervical samples. However, the relative specificity improved following cut-off optimization (ratio: 0.94, 95% CI: [0.88-1.01]). Moderate to excellent agreement in HPV detection between self-collected and cervical samples was demonstrated (Kappa values: 0.53-1.00). To conclude, OncoPredict HPV SCR assay demonstrated similar accuracy on FVU and cervical samples. On vaginal compared to cervical samples sensitivity was similar with a lower specificity, which improved with cut-off optimization.

Indexed as

Early Detection of CancerPapillomavirus InfectionsSensitivity and SpecificitySpecimen HandlingUterine Cervical DysplasiaUterine Cervical NeoplasmsVaginaAdultAgedCervix UteriColposcopyFemaleHumansMass ScreeningMiddle AgedPapillomaviridaecervical cancerdiagnostic accuracy studyEuropean VALHUDESHuman PapillomavirusOncoPredict HPV SCRself‐sampling

Identifiers

PMID39588720
PMCPMC11590042

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.