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TEST:
cobas® HPV test

Company:
Roche
Type:
FDA Approved
Related tests:
Evidence

News

12d
Equivalent clinical accuracy of HPV DNA testing using cobas 4800 and 6800 HPV Systems in paired urine and cervical samples. (PubMed, J Mol Diagn)
Good to excellent HPV test agreements between paired samples were observed (κ=0.68-0.87). In summary, HPV testing using cobas 4800 and 6800 HPV Systems was as accurate on first-void urine as on cervical samples collected by a clinician.
Journal
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cobas® HPV test
23d
Clinical validation of the Roche cobas HPV test on the Roche cobas 6800 system for the purpose of cervical screening and qualification as a second-generation comparator test. (PubMed, J Virol Methods)
The study is the third to show that cobas HPV testing on the 6800 platform consistently demonstrates a relative clinical sensitivity of ≥ 0.95 and a relative clinical specificity of ≥ 0.98 for CIN2 + . This would qualify it, according to a recently published criteria, as a second-generation comparator assay.
Journal
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cobas® HPV test
28d
Cross-Sectional Study on the Detection of HPV Infections for Cervical Cancer Screening Using a Self-Sampling Device. (PubMed, J Low Genit Tract Dis)
This self-sampling device has demonstrated detection rates that are comparable to those of samples collected by clinicians.
Observational data • Journal
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cobas® HPV test
1m
The Prevalence of Human Papillomavirus Genotypes in Women with Precancerous Lesions and Cervical Cancer in Arequipa, Peru. (PubMed, Life (Basel))
Furthermore, 51.9% of patients with cervical cancer tested positive for other high-risk HPV types, whereas 30.8% had HPV-16. Although other HPV genotypes were more frequent than HPV-16 and HPV-18 in individuals with cervical cancer, HPV-16 was the most common individual high-risk genotype in women ≥ 35 years of age with CIN-3.
Journal
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cobas® HPV test
2ms
New trial
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cobas® HPV test
2ms
Multi-center evaluation of the Alinity m HR HPV assay with liquid-based cytology cervical specimens in the United States. (PubMed, Microbiol Spectr)
Extended HR HPV testing can provide additional information to triage patients for appropriate testing and follow-up.IMPORTANCEExtended genotyping for high-risk human papillomavirus (HPV) types enhances diagnostic precision by identifying additional oncogenic HPV types beyond 16 and 18 therefore offering a more nuanced risk profile. This more comprehensive detection may aid in identifying persistent infections that are more likely to progress, thereby supporting future risk-based patient management strategies.
Journal
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ALINITY m HR HPV ASSAY • cobas® HPV test
2ms
Comparison of Liquid-Based Cytology EASYPREP and SurePath for Detection of High-Risk HPV Genotypes. (PubMed, Ann Clin Lab Sci)
Cervical samples with EASYPREP showed good agreement with SurePath samples in terms of hrHPV genotype detection. EASYPREP is worth considering as a safe alternative that can collect and preprocess samples for HPV testing.
Clinical • Review • Journal
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cobas® HPV test
3ms
Performance of HPV Self-Sample Collected by a Novel Kit in Comparison with Clinician Collected Sample for Cervical Cancer Screening. (PubMed, Asian Pac J Cancer Prev)
There was almost perfect or perfect agreement between the HPV self-sample collected by CERVICHECKTM and clinician collected cervical sample. Self-sampling was highly acceptable to the participating women.
Journal • Clinical
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cobas® HPV test
3ms
Evaluation of a Self-collected Device for Human Papillomavirus Screening to Increase Cervical Cancer Screening. (PubMed)
The self-collect device shows high (>92%) positive and negative agreement for detection of HPV when compared with reference clinician-collected samples, with very high acceptability and preference. Furthermore, the self-samples collected with the self-collect device showed highly concordant results by dual stain, which is a novel and emerging application for a self-collected sampling device, thus enabling potential triage from 1 sample.
Journal • Clinical
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BD Onclarity™ HPV Assay • cobas® HPV test
4ms
Human papillomavirus genotype and cycle threshold value from self-samples and risk of high-grade cervical lesions: A post hoc analysis of a modified stepped-wedge implementation feasibility trial. (PubMed)
HPV type and Ct value on HPV-positive self-samples may be used for triage. The difference in the risk of CIN2+ in these groups appears sufficient to justify differential clinical management. A prospective study employing such triage to evaluate laboratory workflow, acceptability, and follow-up procedure and to optimise clinical performance seems warranted.
Journal • Retrospective data
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cobas® HPV test
4ms
Prevalence and genotypic distribution of high-risk human papillomavirus (HPV) among ever-married women in coastal regions of Bangladesh. (PubMed)
The study concludes that among ever-married women in the coastal districts of Bangladesh, there is a low prevalence of high-risk HPV. The predominant high-risk HPV genotypes identified were HPV 16, followed by HPV 66 and 68. These findings hold significant implications for policy makers, providing guidance for targeted screening strategies and vaccination programs.
Journal
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cobas® HPV test
4ms
Exploring the Clinical Signatures of Cervical Dysplasia Patients and Their Association With Vaginal Microbiota. (PubMed)
These results underscore the importance of considering the vaginal microbiota within the cancer microenvironment and highlight the need to integrate all available data to aid in the current diagnosis and understanding of cervical dysplasia and the cervical cancer microenvironment.
Journal
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cobas® HPV test
4ms
Extended HPV genotyping by the BD Onclarity assay: concordance with screening HPV-DNA assays, triage biomarkers, and histopathology in women from the NTCC2 study. (PubMed)
P=N/A; Understanding the degree of concordance among different assays targeting either HPV presence/type(s) or cellular morphology and proteins' expression provides knowledge useful to better define how these tests can be used in screening protocols for an effective triage and to anticipate the possible implementation issues. Our study shows that the concordance between tests is higher when the infections have a higher probability of producing a clinically relevant lesion.
Journal • Clinical • Discordant
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BD Onclarity™ HPV Assay • cobas® HPV test
5ms
Human Papillomavirus Self-Sampling for Unscreened Women Aged 24 Years During the COVID-19 Pandemic. (PubMed)
This study demonstrated that opt-in HPV self-sampling among 24-year-old women who had never been screened for cervical cancer had a favorable kit return rate and was well accepted by the participants, especially during the COVID-19 pandemic. However, the follow-up cytology test rates were low, highlighting the need for improved post-screening management.
Journal
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cobas® HPV test
5ms
Community intervention of a single-dose or 2-dose regimen of bivalent human papillomavirus vaccine in schoolgirls in Thailand: vaccine effectiveness 2 years and 4 years after vaccination. (PubMed)
Our study demonstrated that both single-dose and 2-dose HPV vaccination significantly decreased HPV-16/18 point prevalence 2 years and 4 years after vaccination. Crude vaccine effectiveness at 4 years after vaccination was greater than 90% for both the single-dose and 2-dose regimens; the single-dose regimen was not inferior to the 2-dose regimen. These data show that a single dose of HPV vaccine provides high levels of protection when administered to schoolgirls younger than 15 years of age.
Journal
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cobas® HPV test
5ms
HPV Vaccination and Its Influence on HPV Detection in Women with High-Grade Cervical Dysplasia (AMP 2024)
Due to variable HPV vaccination uptake rates, HPV molecular tests used for cervical cancer screening must be able to detect cervical dysplasia regardless of vaccine status. These data demonstrate that the clinical sensitivity of the Alinity m HR HPV assay for the detection of cervical dysplasia is equivalent to the cobas HPV test in both vaccinated and unvaccinated populations.
Clinical
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ALINITY m HR HPV ASSAY • cobas® HPV test
5ms
Prevalence of vaginal and cervical HPV infection among 35-year age cohort ever-married women in Kalutara district of Sri Lanka and the validity of vaginal HPV/DNA specimen as a cervical cancer screening tool: a cross-sectional study. (PubMed, BMC Infect Dis)
Vaginal HPV/DNA specimen screening method can be used as a cervical cancer screening tool due to its high validity. Pilots of the feasibility should be set up before the regional or national rollout of vaginal sampling strategies.
Journal • Observational data
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cobas® HPV test
6ms
Comparative Analysis of HPV Detection Efficiency: Evaluating Cobas 8800 Performance in Vaginal Self-Sampling versus Clinician-Collected Samples at a Regional Thai Hospital. (PubMed, Diagnostics (Basel))
This work underscores the need for robust sample collection methods and the importance of ongoing enhancements to self-sampling assays and techniques to ensure their efficacy in cervical cancer screening programs.
Journal
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cobas® HPV test
6ms
HPV Screening in Low-resource Settings: A Comparison of Self-Collected Vaginal Swabs Transported With and Without Viral Transport Medium (ASTMH 2024)
Survey responses will be assessed using descriptive analysis. The evidence generated through this study will inform country implementation strategies to support the scale-up of HPV screening, using self-sampling.
cobas® HPV test
6ms
OPTIMUM TRIAGE STRATEGIES FOR HPV POSITIVE WOMEN – RESULTS FROM AN INDIAN STUDY (IGCS 2024)
209 HPV positive women were recruited. The common presentations were postcoital bleeding(11.0%), intermenstrual bleeding(9.6%), postmenopausal bleeding(5.7%), persistent vaginal discharge(65.1%) and unhealthy cervix 8.1%). Test positivity rates, and corresponding referral rates, were 76.0%, 26.0%, 43.1% and 16.7% on VIA, HPV 16/18 genotyping and colposcopy with SS ≥5 and ≥8, respectively.
Clinical
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cobas® HPV test
6ms
A COMPARISON OF SENSITIVITY AND SPECIFICITY OF VARIOUS HPV DNA & MRNA TESTS AMONG SOUTH AFRICAN WOMEN (IGCS 2024)
Enrolled were 1104 women, mean age 41.3 years, 58.7% were HNW. The sensitivity/specificity/PPV/NPV of the different tests to detect CIN3+ in HNW were: Onclarity® 63.8%/82.3%/38.1%/94.7%; HC2 59.2%/83.8%/27.9%/95.1%; Roche cobas® 68.2%/81.6%/29.6%/95.8%; GeneXpert 64.1%/85.1%/33.6%/95.3%; Aptima 36.2%/90.0%/29.2%/92.5% and PreTect-Proofer-8 24.4%/87.6%/13.7%/93.5%. In HPW, respective sensitivity/specificity/PPV/NPV to detect CIN3+ were: Onclarity 80.8%/67.5%/44.7%/91.6%; HC2 77.1%/63.0%/36.0%/91.1%; Roche cobas® 82.1%/61.7%/39.4%/91.9%; GeneXpert 80.2%/64.4%/40.7%/91.4%; Aptima 42.2%/77.0%/36.8%/80.8% and PreTect-Proofer-8 46.4%/66.4%/28.5%/81.1%.
Clinical
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BD Onclarity™ HPV Assay • Xpert HPV Assay • cobas® HPV test
6ms
DETERMINING THE NEED AND BEST METHOD TO TRIAGE HIGH-RISK-HPV POSITIVE SOUTH AFRICAN WOMEN WITH AND WITHOUT HIV CO-INFECTION (IGCS 2024)
1104 women were included, mean age 41.3 years, 41.3% were HIV-positive women (HPW). Histology was available for 768 women (91.7% screen-positives, 42.7% screen-negatives) and confirmed CIN3+ in 92 HPW and 51 HIV-negative women (HNW) (VBA prevalence 23.3% and 10.2% respectively); cervical cancer in 1.4% (VBA: 2.0%). In HPW, sensitivity/PPV for CIN3+ for the five strategies were: A: 82.1%/72.4%; B: 37.7%/88.5%; C: 67.0%/84.6%; D: 70.8%/83.9%; E: 73.6%/83.5% while in HNW values were A: 68.2%/52.6%; B: 34.9%/67.7%; C: 43.9%/77.1%; D:50.0%/74.2%; E: 59.1%/65.6%.
Clinical
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cobas® HPV test
6ms
FEASIBILITY AND COMPLIANCE OF SELF-SAMPLING HPV TESTING: AN EXPERIENCE FROM A REGIONAL CANCER INSTITUTE IN EASTERN INDIA (IGCS 2024)
82.3% (390) women underwent treatment. Conclusions HPV self-sampling is feasible and acceptable method for screening cervical cancer especially for women in rural areas.
Compliance
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cobas® HPV test
6ms
Comparison of cervical cancer screening models based on Pap and HPV tests in Tbilisi, Georgia. (PubMed, Cent Eur J Public Health)
The results suggest that the HPV test with HPV16/18 genotyping and LBC triage is a more effective primary screening method compared to conventional Pap tests. This information should be the basis for transition from cytological screening to HPV testing in Georgia.
Journal • Clinical
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cobas® HPV test
6ms
Clinically validated HPV assays offer comparable long-term safety in primary cervical cancer screening: A 9-year follow-up of a population-based screening cohort. (PubMed, Int J Cancer)
Four clinically validated HPV assays showed comparable safety and better assurance against precancerous lesions than cytology, but some important differences were identified in the performance characteristics of HPV assays impacting the referral rate. Information about the HPV genotype is valuable for guiding further clinical action in HPV-based screening programs.
Journal
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cobas® HPV test
6ms
Characterization of High-Risk-Other Human Papillomavirus Genotypes in Papanicolaou Tests, High-Grade Squamous Intraepithelial Lesions, and Cervical Cancer. (PubMed)
For the HGSIL and cancer samples, 88% of the samples had full HPV genotype coverage with the 9-valent HPV vaccine. This study highlights a presence of HPV that will not be protected by vaccination in a high-risk population.
Journal
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cobas® HPV test
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Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
7ms
Clinico-pathological characteristics and molecular profiling of sinonasal inverted papillomas: a 5-year period institutional retrospective case series (ECP 2024)
The present series demonstrates the presence of EGFR and KRAS mutations and documents the presence of HPV strains in several patients with SIP, alterations associated with squamous carcinomas of the nasal cavity (CNC). However, the low prevalence of the documented alterations in the present series prevents the establishment of a solid causality between these alterations and the development of SIP. New prospective series with larger sample sizes are needed to better understand the clinicopathological implications of the underlying molecular alterations.
Retrospective data
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation • EGFR mutation • EGFR mutation + KRAS mutation
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cobas® KRAS Mutation Test • cobas® HPV test
7ms
Clinical validation of the Roche cobas HPV test on the Roche cobas 5800 system for the purpose of cervical screening. (PubMed, Microbiol Spectr)
Intra- and inter-laboratory reproducibility also fulfills these criteria. The current study demonstrates that the cobas (5800) can be used for primary HPV-based cervical screening on cervical specimens.
Journal
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cobas® HPV test
7ms
Effectiveness of HPV vaccine as part of national immunization program for preventing HPV infection in Thai schoolgirls after seven years post-vaccination. (PubMed, Hum Vaccin Immunother)
Between May and June 2023, 211 grade 12 female students from Ayutthaya, who received the two-dose bivalent HPV vaccine CERVARIXⓇ (HPV types 16 and 18), and 376 grade 12 students from Nakhon Pathom who did not receive the HPV vaccine, were enrolled...Our findings indicated that the bivalent HPV vaccine does not provide cross-protection against non-vaccine HPV types. Prioritizing vaccines with the highest coverage of HR-HPV types, such as the nonavalent HPV vaccine, is crucial to effectively prevent a broader range of HR-HPV infections under the NIP.
Journal
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cobas® HPV test
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Cervarix (recombinant human papillomavirus bivalent vaccine)
7ms
Criteria for second generation comparator tests in validation of novel HPV DNA tests for use in cervical cancer screening. (PubMed)
"Four tests fulfilled the new criteria: (1) RealTime High-Risk HPV Test (Abbott), (2) Cobas-4800 HPV test (Roche Molecular System), (3) Onclarity HPV Assay (BD Diagnostics), and (4) Anyplex II HPV HR Detection (Seegene), each evaluated in three to six studies. Whereas the four assays target 14 carcinogenic genotypes, the first two identify separately HPV16 and 18, the third assay identifies five types separately and the fourth identifies all the types separately."
Journal • Clinical
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Abbott RealTime HR HPV assay • BD Onclarity™ HPV Assay • cobas® HPV test
7ms
HPV Self-Sampling for Cervical Cancer Screening in Under-Screened Saskatchewan Populations: A Pilot Study. (PubMed, Curr Oncol)
While HPV positivity did not differ across the distribution groups, participants at a specific inner-city clinic reported significantly higher positivity to at least one HPV strain as compared to any other clinic and all mailouts combined. For this high-risk population, in-person handout of self-sampling kits may be the most effective means of improving screening.
Journal
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cobas® HPV test
7ms
Impact of STIs on cervical cancer screening: Prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae in visual inspection with acetic acid (VIA) positive women in Mozambique. (PubMed, Int J STD AIDS)
This study highlights the prevalence of CT and NG in VIA-positive women in Mozambique, emphasizing the STI burden and suggesting integration of STI screening in cervical cancer prevention strategies.
Journal
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cobas® HPV test
8ms
Feasibility of Using Needle Rinse Fluid for Cobas Human Papillomavirus (HPV) Assay in Diagnosing HPV+ Oropharyngeal Cancer with Neck Lymph Node Aspiration. (PubMed, Ann Surg Oncol)
The Cobas HPV assay is a US FDA-approved, highly automated, and readily used technique to directly detect the presence of high-risk HPV. We recommend utilizing the Cobas HPV assay in combination with routine cytology or histopathology examination in the work-up of neck lymphadenopathy.
Journal
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cobas® HPV test
8ms
Performance evaluation of the Allplex HPV HR Detection assay in comparison with the Cobas HPV test for high-risk HPV genotyping. (PubMed, Diagn Microbiol Infect Dis)
Sequencing revealed that the majority of discrepancies was genotyped accurately by the Allplex HPV HR Detection assay with the exception of one false positive for HPV-16 and two false positives for other hrHPV genotypes. The Allplex HPV HR Detection assay showed almost perfect agreement with the Cobas HPV test, emphasizing its utility in hrHPV screening and monitoring.
Journal
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cobas® HPV test
8ms
Patient Self-sampling of HPV to Screen for Cervical Cancer (clinicaltrials.gov)
P=N/A; Enrolling by invitation --> Completed | N=125 --> 223
Enrollment change • Trial completion
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cobas® HPV test
9ms
Roche expands access to cervical cancer screening tools with two new WHO prequalification designations, including HPV self-collection (Roche Press Release)
"Roche...announced today that the World Health Organization (WHO) has awarded the cobas® HPV test prequalification designations for use on the cobas® 5800 system and for self-collected samples on the cobas® 5800, 6800 and 8800 systems. These new prequalification designations come just one month after the U.S. Food and Drug Administration approved Roche’s HPV self-collection solution and less than a year after the WHO awarded prequalification to the cobas HPV test on the cobas 6800/8800 systems."
Approval
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cobas® HPV test
9ms
Species-level characterization of the cervicovaginal microbiota and its role in human papillomavirus-associated cervical carcinogenesis. (PubMed, J Med Virol)
The AUCs for the microbiome-, and HPV-based scores were 0.7656 (95% CI 0.6885-0.8426), and 0.7529 (95% CI 0.6855-0.8204), respectively. Bacterial species may be involved in cervical carcinogenesis as the microbiome- and HPV-based scores performed similarly for CIN1+ detection.
Journal
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cobas® HPV test
9ms
Screening outcome of HPV-vaccinated women: Data from the Danish Trial23 cohort study. (PubMed, PLoS One)
Overall, HPV prevalence was high in HPV-vaccinated women, but HPV16/18 had largely disappeared. In the large group of cytology-normal and HPV-positive women, 23 had been followed up per detected CIN2+ case. Our data indicated that primary HPV screening of young HPV-vaccinated women would require very effective triage methods to avoid an excessive follow-up burden.
Journal • Observational data
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cobas® HPV test
9ms
Clinical efficacy of primary human papillomavirus (HPV) screening with partial genotyping for HPV-16 and HPV-18 subtypes in women from 25 years old. (PubMed)
Colposcopy efficacy was similar for HPV-18 and HPV-12 other positivity with abnormal cytology. Taking CIN2+ detection and colposcopy referral rate as endpoints, HPV testing in Singapore can be extended to include women from 25 years old.
Journal • Retrospective data
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cobas® HPV test
10ms
Understanding the high-risk human papillomavirus prevalence and associated factors in the European country with a high incidence of cervical cancer. (PubMed, Eur J Public Health)
We documented a comparison to European Union HR-HPV infection burden in Latvia. Any HR-HPV positivity was significantly associated with sexual and other health behavior.
Journal
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cobas® HPV test
10ms
Effectiveness of high-risk human papillomavirus genotyping for cervical cancer screening. A multicentre screening cohort study in rural China. (PubMed)
High-risk HPV-based screening may significantly reduce the risk of CIN2/3+ compared with cytology testing. This may be a new resource for public health demands in China's rural areas.
Journal
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cobas® HPV test