ArticleJournal of clinical microbiology2012
Clinical validation of a type-specific real-time quantitative human papillomavirus PCR against the performance of hybrid capture 2 for the purpose of cervical cancer screening.
Article in Journal of clinical microbiology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Cytology versus HPV testing for cervical cancer screening in the general population.The Cochrane database of systematic reviews · 2017Pooled it
- Characterization of type-specific HPV prevalence in a population of persistent cutaneous warts in Flanders, Belgium.Scientific reports · 2023Trial
- Diagnostic Translational Considerations for Global Health Settings: Portable Detection of Human Papillomavirus for Cervical Cancer Screening in India.JCO global oncology · 2025Article
- Flexible Electrochemical Biosensor Using Nanostructure-Modified Polymer Electrode for Detection of Viral Nucleic Acids.Biosensors · 2024Article
- Portable, and ultrasensitive HR-HPV tests based on nucleic acid biosensors.Frontiers in cellular and infection microbiology · 2024Review
- Negative Impact of Elevated DNA Fragmentation and Human Papillomavirus (HPV) Presence in Sperm on the Outcome of Intra-Uterine Insemination (IUI).Journal of clinical medicine · 2021Article
- Article
- Performance of OncoE6BMJ open · 2019Article
- Observational
- Clinical performance of Anyplex II HPV28 by human papillomavirus type and viral load in a referral population.PloS one · 2019Article
- Time has come to include Human Papillomavirus (HPV) testing in sperm donor banks.Facts, views & vision in ObGyn · 2018Article
- Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening.Virology journal · 2018Article
- Human papillomavirus genotype and viral load agreement between paired first-void urine and clinician-collected cervical samples.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2018Article
- Performance of a Cartridge-Based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection: Lessons from VALGENT (Validation of HPV Genotyping Tests).Journal of clinical microbiology · 2016Article
- 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
- Prevalence of high-risk human papillomavirus and abnormal pap smears in female sex workers compared to the general population in Antwerp, Belgium.BMC public health · 2016Article
- Long-Term Follow-up of HPV Infection Using Urine and Cervical Quantitative HPV DNA Testing.International journal of molecular sciences · 2016Article
- Human Papillomavirus Laboratory Testing: the Changing Paradigm.Clinical microbiology reviews · 2016Review
- Serial type-specific human papillomavirus (HPV) load measurement allows differentiation between regressing cervical lesions and serial virion productive transient infections.Cancer medicine · 2015Article
- Clinical evaluation of a GP5+/6+-based luminex assay having full high-risk human papillomavirus genotyping capability and an internal control.Journal of clinical microbiology · 2014Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
To be acceptable for use in cervical cancer screening, a new assay that detects DNA of high-risk human papillomavirus (hrHPV) types must demonstrate high reproducibility and performance not inferior to that of a clinically validated HPV test. In the present study, a real-time quantitative PCR (qPCR) assay targeting the E6 and E7 genes of hrHPV was compared with Hybrid Capture 2 (hc2) in a Belgian cervical cancer screening setting. In women >30 years old, the sensitivity and specificity for intraepithelial neoplasias of grade 2 or worse (93 cases of cervical intraepithelial neoplasias of grade 2 or worse (CIN2+) and 1,207 cases of no CIN or CIN1) were 93.6% and 95.6%, respectively, and those of hc2 were 83.9% and 94.5%, respectively {relative sensitivity of qPCR/hc2 = 1.12 [95% confidence interval (CI), 1.01 to 1.23]; relative specificity = 1.01 [95% CI, 0.99 to 1.03]}. A score test showed that the sensitivity (P < 0.0001) and specificity (P < 0.0001) of the qPCR assay were not inferior to those of hc2 at the required thresholds of 90% and 98%, respectively. The overall agreement of hrHPV positivity between the two runs of the qPCR tests was 98.7% (95% CI, 97.5 to 99.4%), with a kappa value of 0.96 (95% CI, 0.83 to 1.00). The qPCR assay used in this study can be considered a reliable HPV assay that fulfills the clinical validation criteria defined for use in cervical cancer screening.
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