Cancers
Multimodal Hyperspectroscopy with LuViva® for Detection of CIN2+ in Women Referred for Colposcopy: A Prospective Diagnostic Accuracy Study
By Sonja Millert-Kalińska, Dominik Pruski and Marcin Przybylski.
Abstract
Objectives
This study aims to evaluate the diagnostic performance of multimodal hyperspectral spectroscopy (MHS) using the LuViva® Advanced Cervical Scan for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women referred for further cervical assessment.
Methods
This prospective, non-randomized diagnostic study included 77 women examined between September 2025 and April 2026. Participants were referred because of abnormal liquid-based cytology (LBC), high-risk human papillomavirus (HR-HPV) infection, or other indications for colposcopy. LuViva examination was performed before colposcopy with cervical biopsy. Histopathological diagnosis based on biopsy or loop electrosurgical excision procedure specimens was used as the reference standard. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were calculated for HR-HPV testing, LBC, and different LuViva positivity thresholds.