TEST:

BD Onclarity™ HPV Assay

Analytical and diagnostic performance of samples collected by the three self-sampling devices resulted in similar quality and HPV detection. Hence the sample quality is not a determinant in the choice of sampling device and focus on other factors such as cost, women's preference or size and weight can take precedence.

Extended genotyping classified 11.5% of 1-year HPV-positive cases as new infections. As 1-year HPV positivity accounts for about 60% of first-level colposcopies, this corresponds to about 7% of colposcopies. Baseline single-channel positivity, age, and p16/ki67-negative results may influence this proportion.

Both clinician- and self-collected samples showed adequate cellularity, with potentially false negative HPV results from low cellular content appearing rare. Observed patterns suggest Ct <26 as optimal and Ct <28 as a minimum for program-level quality assurance with the BD Onclarity™ HPV Assay.

The findings suggest that individuals with HPV16, HPV33/58, and HPV31 infections could be referred immediately to colposcopy. Sending individuals with low-risk genotypes, HPV35/39/68, HPV51, or HPV56/59/66 infections with normal cytology back to routine screening could increase screening specificity.

By fulfilling all guideline requirements for clinical sensitivity, specificity, and reproducibility, Allplex can be considered clinically validated for primary cervical screening using clinician-collected SurePath samples. With this study, Allplex also meets the criteria for a second-generation HPV comparator test.

Extended HPV genotyping may support anal cancer screening strategies by providing a potential standalone tool for both screening and triage. Further studies are needed to confirm these findings in larger cohorts.

P=N/A, N=1226, Completed, Health New Zealand | Te Whatu Ora, Waitemata District

P=N/A, N=300, Completed, University of Milano Bicocca | Recruiting --> Completed

P=N/A, N=12230, Completed, Becton, Dickinson and Company | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Aug 2024 | Trial primary completion date: May 2025 --> Aug 2024

HPV prevalence was shown to be highest in Piura, with the most prevalent types being HPV-16, HPV-52, and HPV-P2 (HPV-56, -59, -66). HPV infection was found to be more frequent among women in the 31-35 years age group.

Human papillomavirus extended genotyping can guide clinical management in the setting of a positive HPV test result.

The self-collect device shows high (>92%) positive and negative agreement for detection of HPV when compared with reference clinician-collected samples, with very high acceptability and preference. Furthermore, the self-samples collected with the self-collect device showed highly concordant results by dual stain, which is a novel and emerging application for a self-collected sampling device, thus enabling potential triage from 1 sample.