ArticleJournal of clinical microbiology2013
Development and characterization of the cobas human papillomavirus test.
Article in Journal of clinical microbiology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers.
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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
53 citing papers in PubMed.
- Clinical Validation of a Vaginal Cervical Cancer Screening Self-Collection Method for At-Home Use: A Nonrandomized Clinical Trial.JAMA network open · 2025Trial
- Increasing coverage in cervical and colorectal cancer screening by leveraging attendance at breast cancer screening: A cluster-randomised, crossover trial.PLoS medicine · 2024Trial
- Value of a catch-up HPV test in women aged 65 and above: A Danish population-based nonrandomized intervention study.PLoS medicine · 2023Trial
- Trial
- Quality assurance of human papillomavirus (HPV) testing in the implementation of HPV primary screening in Norway: an inter-laboratory reproducibility study.BMC infectious diseases · 2016Trial
- Clinical Utility of Cytological Methylation Assay in Cervical Cancer Screening Across Various Cervical Transformation Zones.International journal of cancer · 2026Article
- Multiple High-Risk HPV Infections and Opportunistic HPV Prevalence Among Women Aged 18-25 Years with NILM, ASC-US, or LSIL Cytology: A 2024 Cross-Sectional Study.Pathogens (Basel, Switzerland) · 2026Article
- Head-to-head comparison of the MyGene human papillomavirus-sexually transmitted infection assay versus the Cobas 4800 human papillomavirus test for detecting high-grade cervical intraepithelial neoplasia.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Article
- Prevalence and genotype distribution of human papillomavirus (HPV) in Tehran, Iran: a retrospective cross sectional study (2011-2024).Virology journal · 2026Article
- Mock Samples That Mimic Human Cervicovaginal Samples to Accelerate the Development and Evaluation of Assays for High-Risk HPV for Cervical Cancer Screening.Journal of medical virology · 2026Article
- Review
- Comparative evaluation of microRNA detection in plasma, urine and liquid-based cytology for high-grade cervical intraepithelial neoplasia.Oncology letters · 2026Article
- Development of an HPV 16 rapid test founded in user-centered design with primary care clinicians.Analytical methods : advancing methods and applications · 2026Article
- Comparative efficacy, feasibility and acceptability of HPV DNA testing on first-void urine versus self-collected vaginal samples: a real-world study in a resource-limited setting.BMJ global health · 2026Article
- Article
- Exploring shared microRNA profiles in liquid-based cytology and plasma as biomarkers of high-grade intraepithelial lesions.Scientific reports · 2025Article
- Quality Assurance in Cervical Cancer Screening: Evaluation of Sample Adequacy in HPV DNA Testing.Journal of medical virology · 2025Article
- Triage performance of DNA methylation for women with high-risk human papillomavirus infection.The oncologist · 2025Article
- Validation of an in-house HPV CerviSens self-sampling kit: comparison against clinician-collected and self-collected samples.Frontiers in medical technology · 2025Article
- Triage performance of PAX1Clinical epigenetics · 2024Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The cobas human papillomavirus (HPV) test, approved by the FDA in April 2011, is a fully automated assay for the detection of 14 high-risk (hr) HPV genotypes from cervical specimens collected in liquid-based cytology medium using real-time PCR amplification of the L1 gene and TaqMan probes. Results are simultaneously reported as positive or negative for the pooled 12 oncogenic HPV types (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and -68) from channel 1, with HPV16 and HPV18 genotypes read individually from channels 2 and 3. A fourth channel detects the human β-globin gene as a control for sample adequacy and assay inhibition. To optimize clinical sensitivity and specificity, cutoff values (cycle thresholds [C(T)]) were established for each channel based on the detection of cervical intraepithelial neoplasia grade 2 (CIN2) or greater (≥CIN2). For women aged ≥21 years with cytology results indicating atypical squamous cells of undetermined significance (ASC-US), CT values provided a sensitivity of 90% (95% confidence interval [CI], 81.5% to 94.8%) for the detection of ≥CIN2 and a specificity of 70.5% (95% CI, 68.1% to 72.7%). The analytic sensitivity (limit of detection) ranged from 150 to 2,400 copies/ml, depending on genotype. The analytic specificity, evaluated by comparing the HPV result with a combined comparator of Sanger sequencing and the Qiagen digene HC2 high-risk HPV DNA test (hc2), demonstrated overall positive agreement of 96.3% for 14 hrHPV types in women with ASC-US cytology results who were aged ≥21 years and 86.1% in women with NLIM (negative for intraepithelial neoplasia or malignancy) cytology who were aged ≥30 years. These and other performance validation studies demonstrate that the cobas HPV test is a fully automated and clinically validated robust test.
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