ArticleJournal of clinical microbiology2016
The BD Onclarity HPV Assay on Samples Collected in SurePath Medium Meets the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening.
Article in Journal of clinical microbiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical Utility of Human Papillomavirus Genotyping in Cervical Cancer Screening: A Systematic Review.Journal of lower genital tract disease · 2020Pooled it
- Clinical Validation of Four Point-of-Care High-Risk HPV Assays, Including Two Reduced-Valency Assays, for Cervical Cancer Screening in Low-Resource Settings.International journal of cancer · 2026Article
- Health Care Policy Implementation Trial of Primary Human Papillomavirus-Based Cervical Screening in Denmark.International journal of cancer · 2026Article
- Participation and Follow-Up Compliance in Cervical Cancer Screening According to Delivery Strategy for HPV Self-Collection: A Community Trial in Underserved Colombian Areas.Cancer medicine · 2026Article
- Cost-effectiveness analysis of human papillomavirus (HPV) genotyping strategies for management of HPV-positive women in cervical cancer screening.International journal of cancer · 2026Article
- Evaluation of the Quality and Suitability of Self-Collected Vaginal and Urine Samples for Human Papillomavirus Testing: A Prospective Matched Study.BJOG : an international journal of obstetrics and gynaecology · 2026Article
- Evaluation of targeted next-generation sequencing for detection of HPV genotypes and sublineages in cervical liquid-based cytology SurePath samples from the Danish screening program.International journal of cancer · 2026Article
- Large-Scale Study Comparing Analytical and Diagnostic Quality of Three HPV Self-Sampling Devices for At-Home Cervical Cancer Screening.APMIS : acta pathologica, microbiologica, et immunologica Scandinavica · 2025Article
- Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples.Microbiology spectrum · 2024Article
- HPV Tests Comparison in the Detection and Follow-Up after Surgical Treatment of CIN2+ Lesions.Diagnostics (Basel, Switzerland) · 2022Article
- Evaluation of the characteristics of multiple human papillomavirus (HPV) infections identified using the BD Onclarity HPV assay and comparison with those of single HPV infection.Journal of pathology and translational medicine · 2022Article
- Clinical Validation of the Onclarity Assay After Assay Migration to the High-Throughput COR Instrument Using SurePath Screening Samples From the Danish Cervical Cancer Screening Program.American journal of clinical pathology · 2022Article
- Comparison of Seegene Anyplex II HPV28 assay with BD Onclarity HPV assay for human papillomavirus genotyping.PloS one · 2022Article
- Development of models for cervical cancer screening: construction in a cross-sectional population and validation in two screening cohorts in China.BMC medicine · 2021Article
- Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women: A large European multicenter study.International journal of cancer · 2021Article
- Article
- Clinical and Analytical Performance of the BD Onclarity HPV Assay with SurePath Screening Samples from the Danish Cervical Screening Program Using the VALGENT Framework.Journal of clinical microbiology · 2020Article
- Bayesian analysis of baseline risk of CIN2 and ≥CIN3 by HPV genotype in a European referral cohort.International journal of cancer · 2019Article
- Time and temperature dependent analytical stability of dry-collected Evalyn HPV self-sampling brush for cervical cancer screening.Papillomavirus research (Amsterdam, Netherlands) · 2018Article
- Validation of a Human Papillomavirus (HPV) DNA Cervical Screening Test That Provides Expanded HPV Typing.Journal of clinical microbiology · 2018Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This study describes a validation of the BD Onclarity HPV (Onclarity) assay using the international guidelines for HPV test requirements for cervical cancer screening of women 30 years old and older using Danish SurePath screening samples. The clinical specificity (0.90, 95% confidence interval [CI] = 0.88 to 0.91) and sensitivity (0.97, 95% CI = 0.87 to 1.0) of the Onclarity assay were shown to be not inferior to the reference assay (specificity, 0.90 [95% CI = 0.88 to 0.92]; sensitivity, 0.98 [95% CI = 0.91 to 1.0]). The intralaboratory reproducibility of Onclarity was 97%, with a lower confidence bound of 96% (kappa value, 0.93). The interlaboratory agreement was 97%, with a lower confidence bound of 95% (kappa value, 0.92). The BD Onclarity HPV assay fulfills all the international guidelines for a new HPV test to be used in primarily screening. This is the first clinical validation of a new HPV assay using SurePath screening samples, and thus the Onclarity HPV assay is the first HPV assay to hold an international validation for both SurePath and ThinPrep.
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