TEST:

cobas® HPV test

P=N/A, N=200, Active, not recruiting, University of Rochester | Recruiting --> Active, not recruiting

HPV testing using FVU demonstrates high agreement with vaginal self-sampling, comparable accuracy in detecting CIN2+ lesions and greater acceptability among women. This method is feasible and well-suited for cervical cancer screening in resource-limited settings.

For self-collected vaginal samples of hrHPV-positive women, the Ct value may be used as a triage method to colposcopy. As Ct values inversely reflect the viral loads, they are lower in high-grade CIN and/or carcinoma.

By simplifying and standardizing urine collection and by expanding access beyond traditional clinical settings, this technology has the potential to increase uptake of HPV screening programs by overcoming barriers associated with invasive sampling methods and thereby reduce inequities. More importantly, these methods can contribute to earlier detection and prevention of cervical cancer.

The study confirms the significant burden of cervical neoplasia in WLHIV and demonstrates the feasibility and importance of integrating HPV screening and 'see and treat' services within or near existing ART centres using portable technologies. Leveraging the extensive NACP network offers a strategic opportunity for nationwide implementation, crucial for cervical cancer elimination efforts in this high-risk population.

Women with HR HPV non-16/18 and normal cytology represent a high-risk group requiring long-term follow-up. No malignancies were observed in the first year of follow-up, supporting the recommendation for retesting after 12 months and colposcopy referral if the infection persists.

Urine-based HPV testing using a DNA purification and concentration process is non-inferior to the gold standard Cobas4800 test on provider-collected samples for the detection of high-risk HPV types and the high grades of cervical precancerous lesions. The Experimental Test provides a highly sensitive, reliable, and scalable option for cervical cancer screening, particularly in settings where traditional screening methods are less accessible.

Specifically, recurrence rates (6.2% vs 12.1%) and the incidence of cervical cancer (2% vs 1.5%) were comparable, with no statistically significant differences (p>0.05 for both). CONCLUSIONS HR-HPV-negative CIN3 is a clinically significant entity that requires management and follow-up equivalent to HR-HPV-positive CIN3, as it demonstrates comparable oncologic outcome.

Pathologist-led outreach may help close screening gaps. This study represents the first academic center-led implementation of FDA-approved self-collection in US community settings.

For HPV types 18, 31, 35, 39, 51, 52, 56, 59 and 68, the mean sequence variation was similar between HPV-negative and HPV-positive samples using Anyplex. Our findings show that sequence variation relative to prototypes may impact test performance.

This study represents the largest-scale analysis on the epidemiology of HR-HPV in Ecuador. Given the high prevalence and positive trend of Other HR-HPV, our findings underscore the need for multivalent HPV vaccines. National screening strategies may consider screening of women over the age of 65 years when clinically indicated based on the patient history or physician judgment.

HPV16 and age ≥ 30 years were the most significant predictors of CIN2-3 in women with abnormal cytology, underscoring the dominant oncogenic role of HPV16. Integrating HPV genotyping, cytological findings, and age into risk-stratified algorithms could optimize cervical cancer prevention, ensuring timely detection of high-grade lesions while minimizing overtreatment in low-risk populations.