TEST:

cobas® HPV test

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.

CIN2/3 was detected in 11.4% of WLWH; HPV 18 detection in cervical swabs was strongly associated with CIN2/3. Larger studies among WLWH are needed to determine optimal approaches for screening and treatment to prevent cervical cancer.

HPV self-sampling using the in-house developed HPV CerviSens kit is a reliable and effective method for cervical cancer screening, with high concordance and accuracy in detecting HPV infections. Integrating self-sampling into screening programs can enhance early detection, improve patient outcomes, and significantly reduce the global burden of cervical cancer.

Short-term repeat HPV testing could be a practical option for triaging HPV-positive women, either alone or in combination with limited HPV genotyping.

HPV-tested urine showed non-inferior specificity to cervical samples in a general screening population. Urine self-sampling was acceptable to current attenders but some prefer traditional screening, making choice an important consideration for policy makers.

Annual assessments will sustain quality assurance and equitable access to reliable HPV testing. From 2026, the Peruvian HPV NRL will coordinate the program independently, expand participation to additional laboratories, and enable local panel production-an important step toward strengthening cervical cancer screening quality.