Trial reportCancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology2025
Comparison of Human Papillomavirus Genotyping by Research vs. Clinical Assay for Two Self-Collection Devices.
Trial report in Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- Native American Women's Willingness to Screen for Both Cervical and Colorectal Cancer at Home.Cancer medicine · 2026Article
- Rural women choose self-sampling over a pelvic exam for cervical cancer screening: a mixed-method study.Cancer causes & control : CCC · 2025Article
- A United States study of self-collected urine vs clinician-collected cervical sample for HPV and cervical intraepithelial neoplasia grade two or worse detection: Cross-sectional agreement and diagnostic accuracy study.Preventive medicine reports · 2025Article
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Authors and funding
25 authors.
Funding
Abstract
backgroundHuman 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.
methodsWomen 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 accuracy (sensitivity/specificity ratios) provided the statistical comparison.
resultsThe two devices did not differ in their κ agreement scores for overall HPV detection compared with the speculum-collected sample [κ = 0.83 (0.72-0.94) and κ = 0.90 (0.81-0.98), respectively, nonsignificant exact McNemar test results]. The two devices did not differ in accuracy as measured by the relative sensitivity/specificity for overall HPV at the CIN2+ disease threshold [1.0 (0.15-6.77) and 1.19 (0.56-2.54), respectively]. The two assays did not differ in HPV agreement nor assay accuracy for CIN2+ (n = 10).
conclusionsHPV self-sampling devices robustly detected high-risk HPV types for cervical cancer screening when using the research assay to compare them. Both research and clinical HPV assays provide equivalent HPV detection for specific and aggregated HPV types. IMPACT: This study provides a US-based population to show that self-collection for primary HPV testing is accurate for CIN2+ detection with multiple devices using a validated HPV assay.
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