Comparative study of Exosome Ovarian Cancer auxiliary diagnostic kit (Chemiluminescence) and Serum Tumor Marker CA125 in the diagnosis of Ovarian Epithelial Cell Carcinoma

Abstract

Objective: To compare the diagnostic performance of an exosomal ovarian cancer assay (chemiluminescence) with serum CA125 for epithelial ovarian cancer (EOC), focusing on sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

Methodology: This retrospective study included 200 patients from the Department of Obstetrics and Gynecology, Hospital of 82nd Group Army PLA (June 2023 to December 2024). Participants were divided into a control group (n = 150, including healthy individuals, patients with pelvic inflammatory disease, and other tumors) and an EOC group (n = 50, confirmed by pathology). Serum samples were analyzed using the exosomal kit and CA125. Agreement metrics (PPA, NPA, OPA) with 95% CIs and Kappa consistency were calculated.

Results: There were significant differences in age distribution and menopausal status between the two groups (P<0.05), with marked differences also found in serum HE4, serum CA125, and OCS values between the two groups (P<0.05). The exosomal assay showed a sensitivity of 74.0%, specificity of 99.3%, PPV of 97.4%, and NPV of 92.0%, outperforming CA125 (sensitivity 40.0%, specificity 97.3%, PPV 83.3%, NPV 83.0%). Kappa analysis indicated good agreement between methods (K = 0.797, P < 0.01).

Conclusion: The exosomal ovarian cancer diagnostic kit exhibits superior sensitivity and specificity compared to CA125, suggesting strong potential as a complementary tool for early EOC detection.