Innovative Noninvasive HPV Screening Using a Feminine Pad: A Pilot Study for Enhanced Cervical Cancer Detection.

Abstract

Background: Human papillomavirus (HPV) is a major contributor to cervical cancer (CC), with Papanicolaou (Pap) smears and HPV testing serving as primary screening tools in developed countries. The effectiveness of these methods can vary based on a country's epidemiological and socioeconomic context. This study introduces an innovative, noninvasive method employing surgical gauze worn as a feminine pad for HPV detection, with the aim of simplifying and improving screening processes. Materials and Methods: A total of 184 participants, including individuals classified as healthy, with cervical precursor lesions, or as with confirmed CC, were enrolled. All participants underwent cytological and colposcopic evaluations, with biopsies taken in cases of abnormal results. Each participant wore the device for 8 h, after which DNA was extracted from the soiled devices and analyzed via PCR for mitochondrial and HPV-DNA. Sensitivity and specificity were calculated to assess the effectiveness of HPV detection. Sensitivity and specificity values for HPV detection were obtained. Analysis of diagnostic tests was performed by OpenEpi software. Results: The device was well-received, with high compliance among participants. PCR analysis revealed that 17.7% of healthy, 72.1% of precursor-lesion cases, and 97.1% of CC cases tested positive for HPV. The calculated sensitivity and specificity for detecting high-grade lesions (CIN2+ or CIN2/3 and CC) were 94.81% and 51.28%, respectively. For CC detection, sensitivity was 97.14% with a specificity of 54.39%. Conclusions: The use of this noninvasive device demonstrated a significant correlation with clinical outcomes, supporting its potential as an effective and accessible tool for HPV screening. This method offers a promising alternative to conventional screening techniques, particularly in settings where traditional methods face logistical and socioeconomic challenges.