CITOBOT AI for real-world cervical cancer screening using colposcopy imaging.

Background: Cervical cancer remains a major cause of morbidity and mortality among women, particularly in low- and middle-income countries, where delays in screening and diagnostic follow-up limit early detection. Artificial intelligence applied to medical imaging may strengthen screening programs by improving accuracy, consistency, and timeliness in resource-limited settings. Objective: This study aimed to evaluate the internally validated screening performance of CITOBOT AI, an artificial intelligence system for real-world cervical cancer screening using colposcopy imaging, in a public hospital setting in Colombia. Methods: A cross-sectional study was conducted among 650 women screened at 'Siloé' Hospital in Cali, Colombia, between February 2023 and July 2025. Colposcopy-guided biopsy served as the reference standard. A total of 2,648 cervical images were classified using a predefined binary endpoint: screen-negative/no risk versus screen-positive/at risk. The model was developed using transfer learning, image segmentation, data augmentation, patient-level data partitioning, and five-fold cross-validation within the training subset. Screening performance was evaluated using accuracy, sensitivity, specificity, area under the receiver operating characteristic curve, predictive values, and confusion matrix analysis. A secondary exploratory analysis examined associations between selected clinical variables and AI-based screening classification. Results: CITOBOT AI achieved internally validated screening performance with an accuracy of 94.3%, sensitivity of 93.4%, specificity of 94.9%, and an area under the receiver operating characteristic curve of 0.98. Positive and negative predictive values were 92.9 and 96.2%, respectively. Performance estimates were stable across patient-level folds and consistent with the hold-out validation subset within the same dataset. HPV status showed an unexpected inverse association with AI screen-positive classification; this finding should not be interpreted as biologically protective or as evidence that HPV status influenced model output, since HPV status was not used as an input variable. Conclusion: CITOBOT AI demonstrated promising internally validated performance for real-world cervical cancer screening based on colposcopy imaging. The predefined binary classification is consistent with its intended role as a screening support tool to identify women who may require confirmatory colposcopy and biopsy, while histopathology remains the reference standard for lesion grading and therapeutic decision-making. External validation in independent multicenter and population-based datasets is required before broader implementation.