HPV-Q and PathoDetect-HPV-14 did not meet validation criteria. This study represents the first formal validation of reduced-valency HPV assays and demonstrates that Truenat-HR-HPV-Plus provides robust clinical performance with higher specificity than 14-valent assays, supporting its potential to improve screening efficiency and reduce unnecessary referrals.
Despite the small number of participants in this first year, the study offers early evidence of the strong acceptability and practicality of self-sampling among women in Pirkanmaa, warranting further evaluation at a larger scale.
Following resuspension, samples showed high stability, with reproducibility ranging from (89.4%-100%). These data support the optimisation of laboratory workflows, acceptance criteria, and standardised HPV self-sampling protocols.
Qualitative comments emphasized privacy and reduced distress, including trauma- and dysphoria-related concerns.ConclusionAt-home SC is a clinically valid, usable, and strongly preferred CCS option, particularly among LGBQ+ populations who experience disproportionate barriers to speculum-based CCS. Broader adoption of FDA-authorized at-home SC paired with telehealth will enable future impact assessment to reduce persistent disparities in CCS for LGBQ+ populations.
Self-collected vaginal, urine, and menstrual blood samples show moderate to good concordance with clinician-collected samples for HrHPV detection. However, only self-collected vaginal samples demonstrate comparable sensitivity and specificity for detecting HSIL.
The quadrivalent HPV vaccine has reduced HPV 16/18 prevalence in the targeted younger population. Continued surveillance is warranted, particularly for nonvaccine high-risk types.
This study provided updated hrHPV prevalence estimates that may inform age-based screening strategies and underscored the need for genotype surveillance and risk-based triage approaches.
In addition, WGS-based identification of HPV16 sub-lineages demonstrated that the composite A1, A2, A4, and C1 sub-lineages were associated with a higher risk of abnormal cytology compared to other HPV16 sub-lineages. WGS can further delineate the natural history of anal HR-HPV and their sub-lineages in populations at high-risk for HPV acquisition.
The COARI® self-sampling device demonstrated reliable and effective performance for hrHPV detection and partial typing, showing strong potential to increase access to and coverage of cervical cancer screening in Brazil. Further studies with larger and more diverse populations are needed to validate these findings and inform public health implementation.
HPV vaccination before the first post-treatment follow-up was associated with lower HPV positivity after LEEP. As this outcome is a surrogate endpoint and residual confounding is possible, studies with standardized follow-up and long-term clinical endpoints are needed.
A substantial proportion of women with abnormal cytology in this community cohort harboured non-HPV16 and HPV18 high-risk infections, highlighting the importance of extended HPV genotyping. NGS-based HPV genotyping was concordant with the comparator assay used and had simultaneous STI identification, supporting its potential utility as a comprehensive tool for community-based cervical cancer screening and risk stratification.