[en] In this report, the clinical performance of Liferiver HarmoniaHPV and Liferiver VenusHPV was evaluated under the VALHUDES framework. Five hundred and twenty-three women collected first-void urine (FVU) with Colli-Pee and vaginal samples with Evalyn Brush or Qvintip. Cervical samples were taken with the Cervex Brush by a clinician. Both vaginal and cervical samples were resuspended in 20 mL ThinPrep. Triplet samples from 499 women were tested with HarmoniaHPV and VenusHPV tests. The clinical accuracy of HarmoniaHPV did not differ in FVU and vaginal self-samples versus cervical samples. The relative sensitivity for CIN2+ on FVU and vaginal samples was 0.95 [95% CI 0.89-1.02] and 0.95 [95% CI 0.88-1.02], respectively. Relative specificity for < CIN2 was 0.95 [0.86-1.04] on FVU and 0.93 [0.86-1.01] on vaginal samples. VenusHPV demonstrated lower sensitivity on both self-sample types, whereas the specificity was similar to cervical samples. Post-hoc adjustment of the VenusHPV Ct-values improved sensitivity (ratio FVU/cervical = 0.94 [95% CI 0.88-1.00]; ratio vaginal/cervical = 0.96 [95% CI 0.92-1.01]) without compromising specificity (ratio FVU/cervical = 1.00 [0.92-1.09]; ratio vaginal/cervical = 0.95 [95% CI 0.88-1.02]) on both self-samples. In conclusion, HarmoniaHPV and VenusHPV tests demonstrated similar clinical accuracy on FVU and vaginal self- versus cervical samples, although VenusHPV test required cut-off optimization.
Disciplines :
Oncology
Author, co-author :
Latsuzbaia, Ardashel; Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium
Van Keer, Severien ; Centre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Edegem, Antwerp, Belgium
Broeck, Davy Vanden; Laboratory of Molecular Pathology, AML Sonic Healthcare, Antwerp, Belgium ; National Reference Centre for HPV, Brussels, Belgium ; AMBIOR, Laboratory for Cell Biology & Histology, University of Antwerp, Antwerp, Belgium ; International Centre for Reproductive Health, Ghent University, Ghent, Belgium
Weyers, Steven; Department of Obstetrics and Gynaecology, Ghent University Hospital, Ghent, Belgium
Donders, Gilbert; Department of Obstetrics and Gynaecology of the General Regional Hospital Heilig Hart, Tienen, Belgium ; Femicare vzw, Clinical Research for Women, Tienen ; Department of Obstetrics and Gynaecology University Hospital Antwerp, Antwerp, Belgium
De Sutter, Philippe; Department Gynaecology-Oncology, UZ Brussel-VUB, Brussels, Belgium
Tjalma, Wiebren; Multidisciplinary Breast Clinic, Unit Gynaecologic Oncology, Department of Obstetrics and Gynaecology, Antwerp University Hospital (UZA), Edegem, Belgium ; Molecular Imaging, Pathology, Radiotherapy, Oncology (MIPRO), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium
Doyen, Jean ; Université de Liège - ULiège > Département des sciences de la santé publique
Vorsters, Alex; International Centre for Reproductive Health, Ghent University, Ghent, Belgium
Arbyn, Marc ; Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium ; Department of Human Structure and Repair, Faculty of Medicine and Health Sciences, University Ghent, Ghent, Belgium
Language :
English
Title :
Accuracy of Liferiver HarmoniaHPV and VenusHPV Assays on Urine and Vaginal Self-Samples.
Publication date :
2025
Journal title :
Journal of Medical Virology
ISSN :
0146-6615
eISSN :
1096-9071
Publisher :
John Wiley and Sons Inc, United States
Volume :
97
Issue :
3
Pages :
e70273
Peer reviewed :
Peer Reviewed verified by ORBi
Funding text :
We thank the team members of the Gynaecology departments of Antwerp University Hospital, Ghent University Hospital, General Regional Hospital Heilig Hart Tienen\u2014Femicare vzw, UZ Brussel\u2014VUB and University Hospital Li\u00E8ge for the study recruitment as well as the enrolled women. We thank L. De Baere (AML), D. Maes (AML), and A. De Smet (UAntwerp) for the laboratory work. M.A. and A.L. were supported by the RISCC Network [grant no. 8478459] funded by the Horizon 2020 Program for Research and Innovation of the European Commission (Brussels, Belgium). M.A. was supported by the EU Joint Action EUCanScreen (Grant No. 101162959). S.V.K. was supported by a junior postdoctoral fellowship of the Research Foundation\u2014Flanders (1240220N).The VALHUDES project is a researcher\u2010induced study, designed by Sciensano (Principal Investigator; Brussels, Belgium), CEV (University of Antwerp, Antwerp, Belgium), and AML (Antwerp, Belgium). Manufacturers of HPV assays and devices can participate in the VALHUDES framework contributing equipment for laboratory testing and financial support for statistical analysis under the condition of accepting independent publication of results. This research was supported by Liferiver Bio\u2010Tech (San Diego, Ca), Novosanis NV (Wijnegem, Belgium), and University of Antwerp (Antwerp, Belgium). The study group received sample collection devices from Rovers Medical Devices B.V. (Oss, The Netherlands) and Aprovix AB (Uppsala, Sweden).
M. Arbyn, E. Weiderpass, L. Bruni, et al., “Estimates of Incidence and Mortality of Cervical Cancer in 2018: A Worldwide Analysis,” Lancet Global Health 8, no. 2 (2020): e191–e203.
G. Koliopoulos, V. N. Nyaga, N. Santesso, et al., “Cytology Versus HPV Testing for Cervical Cancer Screening in the General Population,” Cochrane Database of Systematic Reviews 8, no. 8 (2017): Cd008587, https://doi.org/10.1002/14651858.CD008587.pub2.
P. J. Maver and M. Poljak, “Primary HPV-Based Cervical Cancer Screening in Europe: Implementation Status, Challenges, and Future Plans,” Clinical Microbiology and Infection 26, no. 5 (2020): 579–583.
L. Bruni, B. Serrano, E. Roura, et al., “Cervical Cancer Screening Programmes and Age-Specific Coverage Estimates for 202 Countries and Territories Worldwide: A Review and Synthetic Analysis,” Lancet Global Health 10, no. 8 (2022): e1115–e1127.
M. Arbyn, S. B. Smith, S. Temin, F. Sultana, and P. Castle, “Detecting Cervical Precancer and Reaching Underscreened Women by Using HPV Testing on Self Samples: Updated Meta-Analyses,” BMJ 363 (2018): k4823.
F. Verdoodt, M. Jentschke, P. Hillemanns, C. S. Racey, P. J. F. Snijders, and M. Arbyn, “Reaching Women Who Do Not Participate in the Regular Cervical Cancer Screening Programme by Offering Self-Sampling Kits: A Systematic Review and Meta-Analysis of Randomised Trials,” European Journal of Cancer 51, no. 16 (2015): 2375–2385.
B. Serrano, R. Ibáñez, C. Robles, P. Peremiquel-Trillas, S. de Sanjosé, and L. Bruni, “Worldwide Use of HPV Self-Sampling for Cervical Cancer Screening,” Preventive Medicine 154 (2022): 106900.
M. Arbyn, F. Verdoodt, P. J. F. Snijders, et al., “Accuracy of Human Papillomavirus Testing on Self-Collected Versus Clinician-Collected Samples: A Meta-Analysis,” Lancet Oncology 15, no. 2 (2014): 172–183.
M. Arbyn, E. Peeters, I. Benoy, et al., “VALHUDES: A Protocol for Validation of Human Papillomavirus Assays and Collection Devices for HPV Testing on Self-Samples and Urine Samples,” Journal of Clinical Virology 107 (2018): 52–56.
R. Bhatia, E. A. Boada, J. Bonde, et al., “Evaluation of Harmoniahpv Test for Detection of Clinically Significant Human Papillomavirus Infection Using the VALGENT Framework,” Journal of Virological Methods 294 (2021): 114161.
J. F. Cohen, D. A. Korevaar, D. G. Altman, et al., “STARD 2015 Guidelines for Reporting Diagnostic Accuracy Studies: Explanation and Elaboration,” BMJ Open 6, no. 11 (2016): e012799.
A. Latsuzbaia, D. Vanden Broeck, S. Van Keer, et al., “Clinical Performance of the Realtime High Risk HPV Assay on Self-Collected Vaginal Samples Within the VALHUDES Framework,” Microbiology Spectrum 10, no. 5 (2022): e0163122.
S. Van Keer, E. Peeters, D. Vanden Broeck, et al., “Clinical and Analytical Evaluation of the RealTime High Risk HPV Assay in Colli-Pee Collected First-Void Urine Using the VALHUDES Protocol,” Gynecologic Oncology 162, no. 3 (2021): 575–583.
M. Arbyn, C. Depuydt, I. Benoy, et al., “VALGENT: A Protocol for Clinical Validation of Human Papillomavirus Assays,” supplement, Journal of Clinical Virology 76, no. S1 (2016): S14–S21.
M. Arbyn, M. Simon, E. Peeters, et al., “2020 List of Human Papillomavirus Assays Suitable for Primary Cervical Cancer Screening,” Clinical Microbiology and Infection 27, no. 8 (2021): 1083–1095.
F. Wei, D. Georges, I. Man, I. Baussano, and G. M. Clifford, “Causal Attribution of Human Papillomavirus Genotypes to Invasive Cervical Cancer Worldwide: A Systematic Analysis of the Global Literature,” Lancet 404, no. 10451 (2024): 435–444.
A. Latsuzbaia, M. Martinelli, C. Giubbi, et al., “Clinical Accuracy of Oncopredict HPV Quantitative Typing (QT) Assay on Self-Samples,” Journal of Clinical Virology 175 (2024): 105737.
C. Giubbi, M. Martinelli, A. Latsuzbaia, et al., “Clinical Performance of Oncopredict HPV Screening Assay on Self-Collected Vaginal and Urine Specimens Within the VALHUDES Framework,” Journal of Medical Virology 96, no. 11 (2024): e70079.
A. Latsuzbaia, D. Vanden Broeck, S. Van Keer, et al., “Comparison of the Clinical Accuracy of Xpert HPV Assay on Vaginal Self-Samples and Cervical Clinician-Taken Samples Within the VALHUDES Framework,” Journal of Molecular Diagnostics 25, no. 9 (2023): 702–708.
A. Latsuzbaia, S. Van Keer, D. Vanden Broeck, et al., “Clinical Accuracy of Alinity m HR HPV Assay on Self- Versus Clinician-Taken Samples Using the VALHUDES Protocol,” Journal of Molecular Diagnostics 25, no. 12 (2023): 957–966.
S. Van Keer, A. Latsuzbaia, D. Vanden Broeck, et al., “Analytical and Clinical Performance of Extended HPV Genotyping With BD Onclarity HPV Assay in Home-Collected First-Void Urine: A Diagnostic Test Accuracy Study,” Journal of Clinical Virology 155 (2022): 105271.
A. Latsuzbaia, D. Vanden Broeck, S. Van Keer, et al., “Validation of BD Onclarity HPV Assay on Vaginal Self-Samples Versus Cervical Samples Using the VALHUDES Protocol,” Cancer Epidemiology, Biomarkers & Prevention 31, no. 12 (2022): 2177–2184.
M. Arbyn, A. Latsuzbaia, P. E. Castle, V. V. Sahasrabuddhe, and D. V. Broeck, “HPV Testing of Self-Samples: Influence of Collection and Sample Handling Procedures on Clinical Accuracy to Detect Cervical Precancer,” Lancet Regional Health—Europe 14 (2022): 100332.
L. Connor, H. Elasifer, A. Sargent, R. Bhatia, C. Graham, and K. Cuschieri, “Influence of Resuspension Volume on Dry Sampling Devices Taken for Human Papillomavirus Testing: Implications for Self-Sampling,” Biotechniques 74, no. 2 (2023): 77–84.
S. Jordaens, K. Zwaenepoel, W. Tjalma, et al., “Urine Biomarkers in Cancer Detection: A Systematic Review of Preanalytical Parameters and Applied Methods,” International Journal of Cancer 152, no. 10 (2023): 2186–2205.
M. Arbyn, S. Dhillon, and M. Poljak, Validated HPV Tests Usable in Cervical Cancer Screening on Clinician-Collected Cervical Specimens, www.HPVWorld.com (HPV World, 2024), 270, https://www.hpvworld.com/articles/validated-hpv-screening-tests:-the-importance-of-validation/.
M. Martinelli, A. Latsuzbaia, J. Bonde, et al., “Performance of BD Onclarity HPV Assay on FLOQSwabs Vaginal Self-Samples,” Microbiology Spectrum 12 (2024): e0287223.
J. L. Belinson, S. Hu, M. Niyazi, et al., “Prevalence of Type-Specific Human Papillomavirus in Endocervical, Upper and Lower Vaginal, Perineal and Vaginal Self-Collected Specimens: Implications for Vaginal Self-Collection,” International Journal of Cancer 127, no. 5 (2010): 1151–1157.
S. F. Fobian, X. Mei, J. Crezee, et al., “Increased Human Papillomavirus Viral Load Is Correlated to Higher Severity of Cervical Disease and Poorer Clinical Outcome: A Systematic Review,” Journal of Medical Virology 96, no. 6 (2024): e29741.
Y. Zhang, H. Du, A. Xiao, et al., “Verification of the Association of the Cycle Threshold (Ct) Values From HPV Testing on Cobas4800 With the Histologic Grades of Cervical Lesions Using Data From Two Population-Based Cervical Cancer Screening Trials,” Infectious Agents and Cancer 17, no. 1 (2022): 27.
