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Validation of BD Onclarity HPV Assay on Vaginal Self-Samples versus Cervical Samples Using the VALHUDES Protocol
Ardashel Latsuzbaia1, Davy Vanden Broeck2,3,4,5, Severien Van Keer6
1Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.
Summary
Human papillomavirus (HPV) testing accuracy on self-samples is comparable to clinician-taken samples. The VALHUDES study found HPV testing on vaginal self-samples suitable for cervical cancer screening.
Area of Science:
- Gynecology
- Oncology
- Infectious Diseases
Background:
- The VALHUDES protocol evaluated the accuracy of HPV testing on self-collected samples compared to clinician-taken samples.
- This diagnostic accuracy study involved women referred for colposcopy who provided both self-collected and clinician-collected cervical samples.
Purpose of the Study:
- To assess the accuracy of HPV testing on self-samples versus clinician-taken samples.
- To compare the performance of different vaginal self-sampling devices.
Main Methods:
- 485 women with valid results from five colposcopy clinics were analyzed.
- Vaginal self-samples were collected using Evalyn Brush or Qvintip, and clinician-taken cervical samples were collected using Cervex-Brush.
- HPV testing was performed using the BD Onclarity HPV assay, with colposcopy and histology as the reference standard.
Main Results:
- Overall sensitivity for CIN2+ on vaginal self-samples was not significantly different from cervical samples (ratio=0.96).
- Specificity was significantly higher for vaginal self-samples (ratio=1.09).
- Accuracy varied by device: Evalyn-Brush showed similar sensitivity and higher specificity compared to clinician samples, while Qvintip showed slightly lower sensitivity and higher specificity.
Conclusions:
- Clinical accuracy of the BD Onclarity HPV assay on vaginal self-samples is comparable to cervical samples.
- HPV testing on vaginal self-samples, when collected and handled properly, can be utilized in primary cervical cancer screening programs.
- While overall accuracy is similar, differences in performance between self-sampling devices warrant consideration.
