AI Article Synopsis
- The VALHUDES initiative aimed to evaluate the effectiveness of self-collected urine and vaginal samples for detecting cervical precancers compared to traditional clinician-collected cervical samples using the OncoPredict HPV Quantitative Typing assay.
- A study involving 490 women showed that the clinical sensitivity for detecting cervical intraepithelial neoplasia (CIN2+) was comparable between self-collected samples and cervical samples, but specificity was lower for both self-collection methods.
- After optimizing the testing criteria, the OncoPredict HPV QT assay showed similar accuracy in diagnosing cervical precancers from self-collected samples as from clinician-collected cervical samples.
Article 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
Conclusion: Following cut-off optimisation OncoPredict HPV QT assay demonstrated similar accuracy on self-collected versus cervical samples.
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| http://dx.doi.org/10.1016/j.jcv.2024.105737 | DOI Listing |
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