Detection and Genotyping of HPV DNA Using Different Types of Diagnostic Platforms: Observation Research
DOI:
https://doi.org/10.37800/RM.2.2025.448Keywords:
human papillomavirus (HPV), HPV testing, cervical cancer, self-sampling, urine analysis, Colli-pee®, diagnostic test accuracyAbstract
Relevance: A significant obstacle to the implementation of screening programs for the prevention of breast cancer is the reluctance of patients to visit a gynecologist for many subjective reasons. Devices created to address this problem allow women to collect vaginal secretions themselves for subsequent testing for human papillomavirus (HPV). Their predictive value, cost-effectiveness, and usability were also evaluated. It is emphasized that the use of these devices can contribute to an increase in the number of women participating in cervical cancer screening programs.
The study aimed to assess the prognostic value of self-collection of First Void Urine (FVU) by a woman using Novosanis Colli-pee® and sampling of vaginal discharge by a doctor for HPV PCR genotyping.
Materials and Methods: This prospective observational implementation study was conducted within the framework of the current national screening in Almaty (Kazakhstan). The study included 507 non-pregnant women aged 27-69 (mean age was 39.7±7.3 years). They were tested for high-risk HPV by two methods in parallel for AmpliPrime HPV DNA PCR detection of 14 HPV genotypes. Method 1 was self-collection of the first portion of urine using a Novosanis Colli-pee® FVU device (Novosanis, Belgium); Method 2 was sampling of vaginal discharge by a doctor with a the Cervеx Brush in a PreservCyt transport container (ThinPrep; Hologic, Inc., USA).
Results: Using the Colli-pee® device was more efficient than the doctor’s sampling: 19.4% and 11.9%, respectively (OR = 1.6; 95% CI: 0.48-2.45; χ2 = 5.0, pχ2 = 0.025).
Conclusion: The Colli-pee® device for self-collection of vaginal discharge for HPV testing has a high prognostic value and can be recommended as an alternative method for cervical cancer screening.
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