TEST:

cobas® HPV test

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.

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.

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.

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.

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.

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.

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.

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%.

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%.

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.

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.

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.

No abstract available

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.

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.

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.

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.

"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."

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.

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.

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.

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.

P=N/A; Enrolling by invitation --> Completed | N=125 --> 223

"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."

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.

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.

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.

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.

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.

The MolecuTech Real HPV 16/18/HR assay showed good agreement in the detection of HR HPV genotypes, and similar analytical performance for the detection of HR HPV genotypes in samples with abnormal cytological findings.

The Alinity m HR HPV assay demonstrated an OPA of ≥90.3% when compared to the cobas 4800 HPV test across all HR HPV genotypes and cervical cytology grades for cervical specimens collected in SurePath.

In this study HPV16 and HPV18 carried the highest absolute risk followed by HPV45, Other A and Other B. These results indicate that the Alinity m HR HPV assay can effectively predict elevated risk for CIN3 or higher pathology in women 25 years or older. Our findings demonstrate the utility of the Alinity m HR HPV assay in routine cervical cancer screening.

Despite two decades of HPV vaccination, HPV 16 remains highly prevalent, exceeding HPV 18. The majority of high-risk HPV in our cohort belonged to the HR-other group, potentially emerging as more common. Lower prevalence of HPV 16 and 18 is observed in younger patients.

Using hrHPV (any) as primary and both HPV16/18 and cytology as secondary tests, was universally acceptable without an intermediate risk group. Strategies with follow-up groups improved screening performance with smaller treatment numbers, but with effective management of the intermediate risk group as prerequisite.

Conclusion OHR-HPV is prevalent among HIV-infected women across the north and west geopolitical zones of Nigeria. Policies and interventions geared towards curtailing the incidence of cervical cancer are fervently solicited.

Testing of FVU-device-collected urine for HPV was superior to standard-pot-collected urine in colposcopy attendees and has promising sensitivity for CIN2+ detection. General population HPV testing of FVU-device-collected urine will establish its clinical performance and acceptability as an alternative to routine cervical screening.

Preliminary results show a high rate of clearance of HPV16 in patients with HPV16+ CIN2/3, suggesting that this DNA vaccine delivered via electroporation may not only effectively treat precancerous lesions of the cervix but may also eliminate HPV16 infection. Furthermore, this treatment was well tolerated and may be active even in patients living with HIV, a particularly challenging group to treat for HPV-related disease.

The assay has demonstrated a high intra- and inter-laboratory reproducibility, also among the individual genotypes. The Vitro HPV Screening assay is valid for cervical cancer screening and it provides genotyping information on HPV-positive samples without further sample processing in a fully automated workflow.

These data suggest that self-collected vaginal samples enable accurate clinical HPV testing, and that extended ambient dry storage or exposure to extreme temperatures do not influence HPV detection. Further, lack of β-globin amplification in HPV negative samples accurately identified participants that required recollection.

Pap smear abnormalities were detected in 31 patients (3.5 %), and 19 patients had high-risk HPV. Using HPV NGS for screening, rare HPV subtypes were detected, and quantitative values were obtained as read depth.

While this study demonstrated a reasonable kit return rate and indicated the capability of opt-in HPV self-sampling to detect CIN2+ cases in unscreened women, the low ordering rate of kits and suboptimal compliance for follow-up cytology testing highlight significant challenges. The findings suggest the need for more effective strategies to enhance participation in cervical cancer screening programs.

Women undergoing allo-HSCT are at higher risk of HPV infection and premalignant lesions, and consequently, screening programs should be strictly followed- However, pathologists should be aware of the cytological abnormalities associated with busulfan, which may closely mimic HPV-associated lesions.