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Analytical and clinical performance of OncoPredict HPV Screening (SCR) assay on self-collected vaginal and urine specimens within the VALHUDES Framework
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  • Chiara Giubbi,
  • Marianna Martinelli,
  • Ardashel Latsuzbaia,
  • Kate Cuschieri,
  • Hana Elasifer,
  • Anna Iacobone,
  • Fabio Bottari,
  • Andrea Piana,
  • Roberto Pietri,
  • Giancarlo Tisi,
  • Franco Odicino,
  • Marc Arbyn,
  • Clementina Cocuzza,
  • European working group VALHUDES
Chiara Giubbi
Universita degli Studi di Milano-Bicocca Dipartimento di Medicina e Chirurgia
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Marianna Martinelli
Universita degli Studi di Milano-Bicocca Dipartimento di Medicina e Chirurgia
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Ardashel Latsuzbaia
Sciensano
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Kate Cuschieri
Royal Infirmary of Edinburgh
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Hana Elasifer
Royal Infirmary of Edinburgh
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Anna Iacobone
Istituto Europeo di Oncologia
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Fabio Bottari
Istituto Europeo di Oncologia
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Andrea Piana
Universita degli Studi di Sassari Facolta di Medicina e Chirurgia
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Roberto Pietri
UO Coordinamento Consultori Familiari
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Giancarlo Tisi
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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Franco Odicino
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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Marc Arbyn
Sciensano
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Clementina Cocuzza
Universita degli Studi di Milano-Bicocca Dipartimento di Medicina e Chirurgia

Corresponding Author:[email protected]

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European working group VALHUDES
no affiliation
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Abstract

The introduction of self-sampling in cervical cancer screening has raised the importance of HPV testvalidation on self-collected samples. This study aimed to evaluate the clinical performance of the OncoPredict HPV Screening (SCR) assay on self-collected vaginal and first-void urine (FVU) as part of the VALHUDES framework. Vaginal (FLOQSwabs) and FVU (Colli-Pee) samples were self-collected by 500 women referred to colposcopy, followed by a clinician-collected cervical sample prior to colposcopy, which were all tested using OncoPredict HPV SCR. OncoPredict HPV SCR demonstrated similar relative clinical sensitivity to detect cervical intraepithelial neoplasia grade 2 or worse (≥ CIN2) in urine (ratio: 0.95 [95%CI 0.88-1.02]) and vaginal self-samples (ratio: 0.96 [95%CI 0.90-1.02]) compared to cervical samples. The clinical specificity was lower in vaginal but not in urine samples compared to cervical which improved following cut-off optimization. A higher cellularity was found in vaginal as compared to cervical and FVU samples. Moderate to excellent agreement in HPV detection in self-collected samples and cervical scrapes was demonstrated (Kappa values: 0.53 to 1.00). OncoPredict HPV SCR assay demonstrated similar accuracy on self-collected vaginal and FVU samples compared to cervical samples, although cut-off adjustment improved clinical specificity when applied to vaginal samples.
24 Jul 2024Submitted to Journal of Medical Virology
25 Jul 2024Submission Checks Completed
25 Jul 2024Assigned to Editor
25 Jul 2024Review(s) Completed, Editorial Evaluation Pending
25 Jul 2024Reviewer(s) Assigned
03 Sep 2024Editorial Decision: Revise Major
23 Oct 20241st Revision Received
25 Oct 2024Submission Checks Completed
25 Oct 2024Assigned to Editor
25 Oct 2024Review(s) Completed, Editorial Evaluation Pending
25 Oct 2024Reviewer(s) Assigned
07 Nov 2024Editorial Decision: Accept