Clinical accuracy of OncoPredict HPV Quantitative Typing (QT) assay on self-samples
- PMID: 39486311
- DOI: 10.1016/j.jcv.2024.105737
Clinical accuracy of OncoPredict HPV Quantitative Typing (QT) assay on self-samples
Abstract
Background: The VALHUDES initiative was established to assess the clinical accuracy of HPV assays to detect cervical precancers using urine and vaginal self-samples compared to cervical clinician-collected samples. Here, the clinical performance of OncoPredict HPV Quantitative Typing (QT) assay (OncoPredict QT) was evaluated.
Methods: 490 women referred to colposcopy self-collected a urine and a vaginal specimen using Colli-Pee and FLOQSwab, respectively. Subsequently, a colposcopy was performed, and a cervical sample was collected with Cervex-Brush, followed by biopsy if clinically indicated. Vaginal samples were transported dry and resuspended in 5 mL of eNAT medium, whilst cervical brushings were immediately transferred in 20 mL ThinPrep.
Results: The clinical sensitivity of OncoPredict HPV QT testing for CIN2+ in urine and vaginal self-samples was similar to cervical samples (ratios of 0.99 [95 % CI 0.94-1.05] and 1.00 [95 % CI 0.96-1.04]), respectively, when manufacturer's cut-offs were applied. The specificity for <CIN2 on both self-samples was lower than on cervical samples (urine/cervical ratio = 0.91 [95 % CI 0.84-0.98]; vaginal/cervical ratio = 0.90 [95 % CI 0.84-0.98]). Cut-off optimisation improved specificity without compromising sensitivity. Median viral load values adjusted for cellularity were significantly higher in cervical samples compared to urine or vaginal self-samples, in general for all 12 high-risk HPV and in particular for HPV16, 18, 31, 33, 35, 45, 51, 58 (p < 0.05). No difference was observed in median viral loads between urine and vaginal samples.
Conclusion: Following cut-off optimisation OncoPredict HPV QT assay demonstrated similar accuracy on self-collected versus cervical samples.
Keywords: Cervical cancer prevention; Diagnostic accuracy study; HPV; OncoPredict; Self-sampling; VALHUDES.
Copyright © 2024. Published by Elsevier B.V.
Conflict of interest statement
Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The European VALHUDES is an investigator initiated study, coordinated by 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 contributing equipment for laboratory testing under the condition of accepting independent publication of results. Funding received from the companies are managed by the directors of the respective collaborating institutions. Sciensano authors do not have any personal or material conflict of interest. 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). CEC declares to have received research support from BD Diagnostics, Seegene, Arrows Diagnostics, Copan, GeneFirst, Hiantis and VITRO; CEC is a minority share-holder of Hiantis. ADI, AFP, FB, FO, GT, HE, KC, MM, CG, RP declare no conflict of interest.
