Clinical performance of the HPV-Risk assay on cervical samples in SurePath medium using the VALGENT-4 panel

Area of Science:

• Gynecologic Oncology
• Molecular Diagnostics
• Public Health Screening

Background:

• The VALidation of HPV GENoyping Tests (VALGENT) framework facilitates the clinical validation of Human Papillomavirus (HPV) assays.
• Accurate HPV testing is crucial for effective cervical cancer screening and prevention strategies.

Purpose of the Study:

• To evaluate the diagnostic accuracy of the HPV-Risk assay within the VALGENT-4 framework.
• To compare the performance of the HPV-Risk assay against established, clinically validated comparator HPV tests.

Main Methods:

• Utilized the VALGENT-4 panel, comprising 1,295 SurePath cervical samples, including those with abnormal cytology and high-grade cervical intraepithelial neoplasia (CIN2+).
• Performed the HPV-Risk assay on extracted DNA, blinded to clinical and cytological data.
• Assessed assay accuracy for detecting CIN grade 3 or worse (CIN3+) and CIN2+ relative to GP5+/6+-PCR-EIA and GP5+/6+-PCR-EIA-LMNX.

Main Results:

• The HPV-Risk assay demonstrated sensitivity comparable to GP5+/6+-PCR-EIA for CIN3+ and CIN2+ detection.
• Significantly higher specificity was observed for the HPV-Risk assay compared to GP5+/6+-PCR-EIA.
• Non-inferior accuracy for CIN3+ and CIN2+ detection was confirmed against both comparator assays, with high HPV16/18 genotype agreement.

Conclusions:

• The HPV-Risk assay meets non-inferiority criteria when compared to validated comparator assays using the VALGENT-4 panel.
• The assay's performance on SurePath cervical samples supports its utility in routine cervical cancer screening programs.