Clinical accuracy of OncoPredict HPV Quantitative Typing (QT) assay on self-samples

Area of Science:

• Gynecology
• Oncology
• Molecular Diagnostics

Background:

• The VALHUDES initiative evaluated HPV assays for cervical precancer detection.
• Assessing the clinical accuracy of self-sampled specimens is crucial for improving screening accessibility.

Purpose of the Study:

• To evaluate the clinical performance of the OncoPredict HPV Quantitative Typing (QT) assay.
• To compare the accuracy of HPV detection in urine and vaginal self-samples versus clinician-collected cervical samples.

Main Methods:

• 490 women undergoing colposcopy provided urine and vaginal self-samples.
• Cervical samples were collected, followed by colposcopy and biopsies if needed.
• OncoPredict HPV QT assay was performed on all sample types.

Main Results:

• Clinical sensitivity for CIN2+ was similar between self-samples and cervical samples (urine/cervical ratio 0.99, vaginal/cervical ratio 1.00).
• Specificity for
• Median viral loads were higher in cervical samples compared to self-samples for most high-risk HPV types.

Conclusions:

• The OncoPredict HPV QT assay demonstrates comparable accuracy for cervical precancer detection using self-collected urine and vaginal samples versus clinician-collected samples after cut-off optimization.
• Self-sampling methods offer a promising alternative for HPV testing, potentially increasing screening participation.