ArticleDiagnostics (Basel, Switzerland)2022
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.
Article in Diagnostics (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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
19 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Human papillomavirus self-sampling in Asia: a systematic review.Frontiers in microbiology · 2025Pooled it
- Comparison of three different hpv self-sampling tools - a subanalysis of the prospective, randomized hannover self-collection study.Archives of gynecology and obstetrics · 2026Trial
- Integrating non-coding RNA profiling with HPV genotyping for cervical cancer risk stratification and early detection.Molecular biology reports · 2026Review
- Development of a novel, urine-based high-risk human papillomavirus polymerase chain reaction test to predict cervical intraepithelial neoplasia abnormalities associated with cervical cancer.Microbiology spectrum · 2026Article
- Performance of a novel, urine-based test for the detection of cervical human papillomavirus infection.Journal of clinical microbiology · 2026Article
- Self-collection for primary HPV screening using dry swabs: a review of clinical performance, laboratory considerations, and patient preferences.Journal of clinical microbiology · 2026Review
- Comparative Distribution of High-Risk Human Papillomavirus (HPV) Genotypes in India vs World Health Organization Regions and Countries: Implications for HPV Vaccination.Ochsner journal · 2026Article
- 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
- COVID-19 Pandemic Impact on Delays in Diagnosis and Treatment for Cervical Cancer in Montreal, Canada.Current oncology (Toronto, Ont.) · 2025Article
- Recent Advances in HPV Detection: From Traditional Methods to Nanotechnology and the Application of Quantum Dots.International journal of nanomedicine · 2025Review
- Addressing COVID-19 Screening Delays: The Impact of HPV Self-Sampling on Non-Attenders in a Cervical Cancer Screening Program.Cancers · 2024Article
- Article
- Human Papillomavirus Genotypes Distribution in High-Grade Cervical Lesions and Invasive Cervical Carcinoma in Women Living in Mauritania: Implications for Cervical Cancer Prevention and HPV Prophylactic Vaccination.Diagnostics (Basel, Switzerland) · 2024Article
- Variables that impact HPV test accuracy during vaginal self collection workflow for cervical cancer screening.Gynecologic oncology reports · 2024Review
- 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
- Quantification of HPV16 E7 Oncoproteins in Urine Specimens from Women with Cervical Intraepithelial Neoplasia.Microorganisms · 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
- Preliminary Results of Feasibility and Acceptability of Self-Collection for Cervical Screening in Italian Women.Pathogens (Basel, Switzerland) · 2023Article
- The Editorial of the Special Issue "Diagnosis of Lower Genital Tract Disease".Diagnostics (Basel, Switzerland) · 2023Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The accuracy of available HPV molecular assays on self-samples needs to be evaluated as compared to clinician-collected samples. This pilot study aimed to investigate the BD Onclarity™ HPV assay on vaginal and first-void urine samples. Sixty-four women referred to colposcopy for cervical dysplasia performed a vaginal self-collection and provided a first-void urine sample, after informed consent. A cervical specimen was collected during the clinician examination. All samples were tested using BD Onclarity™ HPV assay on the BD Viper™ LT System. Overall positive agreement (OPA) between cervical and self-sample results was evaluated using Cohen's kappa value (κ). Using a clinical cut-off of 38.3 Ct for HPV 16 and 34.2 Ct for other HR genotypes, compared to cervical sample, the self-collected vaginal sample OPA was 85.9%, and κ = 0.699. Without a clinical cut-off, the OPA was 95.3%, and the κ = 0.890. Data obtained comparing cervical and urine samples showed an OPA of 87.5% with a κ = 0.79 using a clinical cut-off, and an OPA of 90.6% with a κ = 0.776 without a clinical cut-off. Data showed a substantial agreement between both self-collected and clinician-collected samples. A specific clinical cut-off analysis should be considered based on type of sample analysed.
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