Intelligent POCT for ovarian cancer: Dual-biomarker detection combined with ROMA risk assessment using selenium...

The early diagnosis of ovarian cancer remains dissolved due to the lack of detection methods that are sensitive, rapid and accessible. To address this clinical challenge, this study developed an innovative diagnostic platform integrating a novel selenium nanoparticles (SeNPs) probe, dual-biomarker (CA125 and HE4) detection and intelligent analysis system. The detection limits for CA125 and HE4 were determined to be 35 U/mL and 100 pmol/L respectively, and no cross-reactivity was observed. Capitalizing on computer vision and AI prompt engineering technology, this study implemented smartphone-based image acquisition combined with AI-assisted analysis. The results of 360 clinical samples testing indicated that the coincidence rate of this kit with chemiluminescence method was over 95%, and the AUC of the combined detection of dual markers reached 0.914. By integrating the ROMA algorithm, the risk probability of ovarian cancer can be calculated in real time based on the test results and the patient's menopausal status, enabling quantitative risk assessment. This study provides a stable, highly specific, cost-effective and clinically decision supported point-of-care diagnostic solution for the early screening of ovarian cancer, promoting the development of POCT technology towards intelligence and precision.