ArticleFrontiers in medicine2026
Diagnostic performance and interobserver agreement of O-RADS US v2022 and its combination with serum biomarkers in surgically treated epithelial ovarian-adnexal masses.
Article in Frontiers in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objective: To evaluate the diagnostic performance of the American College of Radiology (ACR) Ovarian-Adnexal Reporting and Data System for Ultrasound (O-RADS US v2022) and a combined O-RADS US v2022-CA125-HE4 model in differentiating benign from borderline or malignant epithelial ovarian-adnexal masses, and to assess interobserver agreement for O-RADS US v2022 classification. Methods: This retrospective study included 282 histopathologically confirmed epithelial ovarian-adnexal lesions from 270 surgically treated patients between January 2022 and June 2025. Of the 282 lesions, 233 were benign and 49 were borderline/malignant, with borderline tumors included in the disease-positive group for the primary binary diagnostic analysis. Two sonographers with different levels of experience independently classified stored ultrasound images according to O-RADS US v2022. Categories 4-5 were prespecified as test-positive. Analyses of the combined O-RADS US v2022-CA125-HE4 model were restricted to 238 lesions with complete CA125 and HE4 data. Results: Among the 282 lesions, 233 (82.6%) were benign and 49 (17.4%) were borderline/malignant. In a sensitivity analysis excluding borderline tumors, all 20 invasive malignant lesions were classified as O-RADS US v2022 categories 4-5 by both sonographers. Using O-RADS US v2022 categories 4-5 as test-positive, Sonographer A achieved an AUC of 0.924 (95% CI, 0.892-0.955), with a sensitivity of 0.980, specificity of 0.670, PPV of 0.384, and NPV of 0.994. Sonographer B achieved an AUC of 0.904 (95% CI, 0.863-0.945), with a sensitivity of 0.980, specificity of 0.674, PPV of 0.387, and NPV of 0.994. The AUC was 0.769 (95% CI, 0.684-0.853) for CA125 alone and 0.689 (95% CI, 0.593-0.784) for HE4 alone. Among the 238 lesions with complete biomarker data, the combined O-RADS US v2022-CA125-HE4 model yielded an AUC of 0.937 (95% CI, 0.901-0.972), with a sensitivity of 0.721, specificity of 0.954, PPV of 0.775, and NPV of 0.939. Interobserver agreement for O-RADS US v2022 classification was excellent (linearly weighted κ = 0.963; 95% CI, 0.940-0.982). Conclusion: In this selected retrospective surgical cohort, O-RADS US v2022 demonstrated good diagnostic discrimination and excellent interobserver agreement. The combined O-RADS US v2022-CA125-HE4 model showed higher specificity but lower sensitivity than O-RADS US v2022 alone, without a statistically significant difference in AUC. Prospective external validation is required before clinical implementation.
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