Role of the novel optoelectronic imaging tracing system in cervical cancer screening: preliminary outcomes of a multi-center study.
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OBJECTIVE: This study aimed to evaluate the diagnostic performance of the novel Optoelectronic Imaging Tracing System as a triage or adjunct tool for women with high-risk human papillomavirus (hrHPV) infections. METHODS: Between June 2024 and August 2024, 581 women aged 18 to 65 years undergoing colposcopy were enrolled. The performance of hrHPV testing, cytology, the Optoelectronic Imaging Tracing System, and their combinations in detecting cervical intra-epithelial neoplasia grade 2 or worse and cervical intra-epithelial neoplasia grade 3 or worse was compared by assessing sensitivity, specificity, odds ratios, and area under the receiver operating characteristic curve (AUC). RESULTS: The Optoelectronic Imaging Tracing System demonstrated high sensitivity for detecting cervical intra-epithelial neoplasia grade 2 or higher (96.0%, 95% CI 93.5% to 98.6%) and grade 3 or higher (95.5%, 91.1% to 99.8%), and showed the highest odds ratios for detecting grade 2 or higher (26.0, 13.6 to 56.3) and grade 3 or higher (10.2, 3.72 to 43.3), respectively. In contrast, HPV16/18 genotyping had the highest specificity (65.9% [61.0% to 70.8%] and 63.7% [59.4% to 67.9%], respectively). In detecting cervical intra-epithelial neoplasia grade 2 or higher, the best AUC was achieved by the Optoelectronic Imaging Tracing System alone (0.742, 0.713 to 0.771), whereas the combination of the Optoelectronic Imaging Tracing System and HPV16/18 genotyping had the best AUC in detecting cervical intra-epithelial neoplasia grade 3 or higher (0.699, 0.645 to 0.753). No complaints or adverse events were reported by the participants. CONCLUSIONS: This exploratory study demonstrated the potential of the Optoelectronic Imaging Tracing System as a safe and effective triage or adjunct tool for detecting high-grade cervical lesions in women with hrHPV infections.