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TEST:
cobas® HPV test

Company:
Roche
Type:
FDA Approved (PMA)
Related tests:
Evidence

News

1d
Development of a novel, urine-based high-risk human papillomavirus polymerase chain reaction test to predict cervical intraepithelial neoplasia abnormalities associated with cervical cancer. (PubMed, Microbiol Spectr)
Optimization of cycle threshold cut-offs yielded 93% sensitivity and 77% specificity for predicting CIN2+ in an enriched population. It can enhance accessibility, compliance, and early detection across diverse clinical settings.
Journal • Polymerase Chain Reaction
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cobas® HPV test
8d
Human papillomavirus genotypes and factors associated with major cervical smear abnormalities in a sickle cell endemic area of Kisangani, Democratic Republic of the Congo. (PubMed, PLoS One)
Our study shows a high prevalence of cervical HR-HPV infection in Kisangani, DRC. HPV35, HPV52, and HPV31 are the three most common genotypes, while novel variants of HPV types 103 and 223 were identified. Our findings also highlight that advanced age, HPV33 infection and intravaginal herbal use are the main factors associated with major cervical abnormalities. Although HbAS has not been associated with HR-HPV infection or cervical lesions, further studies are needed to determine this association in women with sickle cell disease (HbSS).
Journal
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cobas® HPV test
8d
Prevalence and genotype distribution of human papillomavirus (HPV) in Tehran, Iran: a retrospective cross sectional study (2011-2024). (PubMed, Virol J)
This study contributes valuable insights into HPV prevalence and genotype distribution in samples collected over a 14-year period in Tehran. The high prevalence of HPV infection, particularly with high-risk Genotypes coupled with the highest prevalence observed in the 20-30 year age group and HPV-16 being common in younger ages, without clinical sign of infection, underscores the necessity for sustained vigilance in monitoring HPV prevalence, early detection through screening, and targeted prevention programs, and comprehensive cervical cancer prevention strategies.
Observational data • Retrospective data • Journal
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cobas® HPV test
10d
Clinical Validation of Four Point-of-Care High-Risk HPV Assays, Including Two Reduced-Valency Assays, for Cervical Cancer Screening in Low-Resource Settings. (PubMed, Int J Cancer)
HPV-Q and PathoDetect-HPV-14 did not meet validation criteria. This study represents the first formal validation of reduced-valency HPV assays and demonstrates that Truenat-HR-HPV-Plus provides robust clinical performance with higher specificity than 14-valent assays, supporting its potential to improve screening efficiency and reduce unnecessary referrals.
Journal
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cobas® HPV test
13d
Introducing self-sampling for cervical cancer screening: A regional implementation study in Pirkanmaa, Finland. (PubMed, Acta Obstet Gynecol Scand)
Despite the small number of participants in this first year, the study offers early evidence of the strong acceptability and practicality of self-sampling among women in Pirkanmaa, warranting further evaluation at a larger scale.
Journal
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cobas® HPV test
22d
HPValidate - Technical Optimisation of Self-Collected Samples for HPV Testing within the NHS England Cervical Screening Programme. (PubMed, J Virol Methods)
Following resuspension, samples showed high stability, with reproducibility ranging from (89.4%-100%). These data support the optimisation of laboratory workflows, acceptance criteria, and standardised HPV self-sampling protocols.
Journal
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Aptima® HPV Assay • cobas® HPV test
1m
Addressing Cervical Cancer Screening Disparities: At-Home Self-Collection Among LGBQ+ Populations. (PubMed, Cancer Control)
Qualitative comments emphasized privacy and reduced distress, including trauma- and dysphoria-related concerns.ConclusionAt-home SC is a clinically valid, usable, and strongly preferred CCS option, particularly among LGBQ+ populations who experience disproportionate barriers to speculum-based CCS. Broader adoption of FDA-authorized at-home SC paired with telehealth will enable future impact assessment to reduce persistent disparities in CCS for LGBQ+ populations.
Journal
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cobas® HPV test
2ms
HPV Detection in Clinician-Collected, Self-Collected Vagina, Urine, and Menstrual Blood Samples. (PubMed, J Low Genit Tract Dis)
Self-collected vaginal, urine, and menstrual blood samples show moderate to good concordance with clinician-collected samples for HrHPV detection. However, only self-collected vaginal samples demonstrate comparable sensitivity and specificity for detecting HSIL.
Journal
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cobas® HPV test
2ms
HPV Prevalence Among Inuit Women in Northern Quebec, Canada: A Pre- and Post-Vaccination Analysis. (PubMed, J Low Genit Tract Dis)
The quadrivalent HPV vaccine has reduced HPV 16/18 prevalence in the targeted younger population. Continued surveillance is warranted, particularly for nonvaccine high-risk types.
Journal
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cobas® HPV test
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Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine)
3ms
Genotype-specific prevalence of high-risk human papillomavirus among cytologically normal women in Taiwan. (PubMed, Taiwan J Obstet Gynecol)
This study provided updated hrHPV prevalence estimates that may inform age-based screening strategies and underscored the need for genotype surveillance and risk-based triage approaches.
Journal
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cobas® HPV test
4ms
Journal • Head-to-Head
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cobas® HPV test
4ms
Comparison of Whole-Viral Genome Sequencing and PCR-based assay for Anal HPV Detection to Inform Clinical Implementation. (PubMed, J Virol Methods)
In addition, WGS-based identification of HPV16 sub-lineages demonstrated that the composite A1, A2, A4, and C1 sub-lineages were associated with a higher risk of abnormal cytology compared to other HPV16 sub-lineages. WGS can further delineate the natural history of anal HR-HPV and their sub-lineages in populations at high-risk for HPV acquisition.
Journal
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cobas® HPV test