Comparison of Human Papillomavirus Genotyping by Research vs. Clinical Assay for Two Self-Collection Devices.

ABSTRACT:

Background

Human papillomavirus (HPV) assays and self-collection devices for HPV detection have evolved. We aim to compare two self-sampling devices against speculum-based testing for HPV genotype agreement and their accuracy for cervical intraepithelial neoplasia grade 2 (CIN2+) disease. Secondarily, we aim to compare two HPV assays for different HPV genotype detection agreement and their accuracy for CIN2+ disease.

Methods

Women from colposcopy (N = 97) and primary care (N = 96) were block-randomized to two different self-sampling device groups. Self-sampling and speculum-collected pairs of HPV specimens were analyzed with the research assay. A second speculum-collected specimen provided clinical results using the clinical HPV assay. Agreement (prevalence-based κ) and accu

SUBMITTER: Harper DM 

PROVIDER: S-EPMC12213154 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature