Abstract / Summary
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. Results: The mean age was 39.0 ± 8.4 years. The final histopathology showed no lesions in 30 women, LSIL in 18, HSIL in 28, and cervical cancer in one. For CIN2+ detection, HR-HPV testing demonstrated a sensitivity of 93.1% and specificity of 29.2%, whereas LBC had a sensitivity of 82.8% and specificity of 39.6%. LuViva testing showed sensitivities between 82.8% and 100%, and a specificity—when comparing with LBC—of 45.8% but 20.8% in LuViva alone. LuViva results differ significantly between women with CIN2+ and those with LSIL or no lesions. Conclusions: LuViva showed potential as an adjunctive triage tool, as no CIN2+ lesions were observed among women with a low-risk result; however, the small number of negative tests and wide confidence intervals preclude safely deferring colposcopy. The AND strategy showed a modest numerical improvement in specificity and overall accuracy compared with LBC alone but did not show an increase in sensitivity; this finding should be considered exploratory.