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. 2024 Nov;96(11):e70079.
doi: 10.1002/jmv.70079.

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

Chiara Giubbi  1 , Marianna Martinelli  1 , Ardashel Latsuzbaia  2 , Kate Cuschieri  3   4 , Hana Elasifer  3   4 , Anna Daniela Iacobone  5 , Fabio Bottari  6 , Andrea Fausto Piana  7 , Roberto Pietri  8 , Giancarlo Tisi  9 , Franco Odicino  9 , Marc Arbyn  2   10 , Clementina Elvezia Cocuzza  1 ; European VALHUDES Working Group
Collaborators, Affiliations

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

Chiara Giubbi et al. J Med Virol. 2024 Nov.

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.

Keywords: European VALHUDES; Human Papillomavirus; OncoPredict HPV SCR; cervical cancer; diagnostic accuracy study; self‐sampling.

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Conflict of interest statement

The European VALHUDES is a researcher‐induced study, coordinated by the University of Milano‐Bicocca (Milan, Italy), Sciensano (Bruxelles, Belgium), Istituto Europeo di Oncologia (Milan, Italy), University of Sassari (Sassari, Italy), U.O. Coordinamento Consultori Familiari, ASSL Sassari–ATS Sardegna (Sassari, Italy), NHS Lothian, University of Edinburgh (Edinburgh, Scotland), Trinity College Dublin (Dublin, Ireland).

Manufacturers of HPV assays (GeneFirst, Oxford, UK and Hiantis, Milan, Italy) and devices (Copan Italia Spa, Brescia, Italy and Novosanis, Belgium) participated in the European VALHUDES framework under the condition of accepting independent publication of results. Funding received from the companies are managed by the directors of the respective collaborating institutions. The study group received free self‐sample collection devices from Copan Italia Spa (Brescia, Italy) and Novosanis (Belgium) and free OncoPredict HPV assay from (Hiantis, Milan, Italy).

C.E.C. declares to have received research support from BD Diagnostics, Seegene, Arrows Diagnostics, Copan, GeneFirst, Hiantis and VITRO. CEC is a minority shareholder of Hiantis.

Sciensano authors do not have any personal or material conflict of interest. A.D.I., A.F.P., F.B., F.O., G.T., H.E., K.C., M.M., C.G., R.P. declare no conflict of interest.

Figures

Figure 1
Figure 1
Flowchart of samples included in the analysis for the accuracy of OncoPredict HPV SCR assay within the VALHUDES Framework.
See this image and copyright information in PMC

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