ArticlePapillomavirus research (Amsterdam, Netherlands)2016
Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples.
Article in Papillomavirus research (Amsterdam, Netherlands), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01671462 (European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.
- Clinical Utility of Human Papillomavirus Genotyping in Cervical Cancer Screening: A Systematic Review.Journal of lower genital tract disease · 2020Pooled it
- Controlled trial of cervical cancer screening frequency among human-papillomavirus-vaccinated women.International journal of cancer · 2026Trial
- Detection of Cervical Neoplasia by Human Papillomavirus Testing in an Atypical Squamous Cells-Undetermined Significance Population: Results of the Becton Dickinson Onclarity Trial.American journal of clinical pathology · 2019Trial
- Oral Treatment with EGCG, Folic Acid, Vitamin B12, and Hyaluronic Acid Improves HPV Clearance and Counteracts Its Persistence: A Clinical Study.International journal of molecular sciences · 2025Article
- Evolving HPV diagnostics: current practice and future frontiers.Frontiers in cellular and infection microbiology · 2025Review
- Article
- Counteracting HPV Cervical and Anal Infection through Dietary Supplementation of EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid: Clinical Case Reports.Journal of clinical medicine · 2024Article
- Polyhexamethylene Biguanide Reduces High-Risk Human Papilloma Virus Viral Load in Cervical Cell Samples Derived from ThinPrep Pap Test.Current issues in molecular biology · 2024Article
- Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples.Microbiology spectrum · 2024Article
- Evaluation of BD Onclarity™ HPV Assay on Self-Collected Vaginal and First-Void Urine Samples as Compared to Clinician-Collected Cervical Samples: A Pilot Study.Diagnostics (Basel, Switzerland) · 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
- Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2020Article
- Approaches to triage optimization in HPV primary screening: Extended genotyping and p16/Ki-67 dual-stained cytology-Retrospective insights from ATHENA.International journal of cancer · 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
- The BD Onclarity HPV Assay on Samples Collected in SurePath Medium Meets the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening.Journal of clinical microbiology · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe novel BD Onclarity
methods276 women from Copenhagen, Denmark were referred for colposcopy with abnormal cytology and/or a positive HPV test. Two samples for HPV analysis were taken in BD SurePath™ and in the BD cervical brush diluent (CBD) media. ClinicalTrial gov. identifier: NCT01671462, Ethical Approval: H-4-2012-070.
resultsHistology was normal in 84 (31%) women, 70 (26%) had CIN1, 47 (17%) CIN2, and 68 (25%) had CIN3. The Onclarity assay detected 67 out of 68 (99%) ≥CIN3 and 113/115 (98%) ≥CIN2. The specificities for <CIN2 were 21%, 17%, and 22%, for HC2, Onclarity and LA, respectively.
conclusionOverall, the Onclarity HPV assay performed well on SurePath LBC and CBD media, with clinical sensitivity and specificity matching those of HC2 and LA.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.