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Clinical accuracy of OncoPredict HPV Quantitative Typing (QT) assay on self-samples
Ardashel Latsuzbaia1, Marianna Martinelli2, Chiara Giubbi2
1Unit of Cancer Epidemiology, Belgian Cancer Centre, Sciensano, Brussels, Belgium.
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
Conclusion:
Following cut-off optimisation OncoPredict HPV QT assay demonstrated similar accuracy on self-collected versus cervical samples.
