Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS, and YiDiXie™-D in Ovarian cancer

Background: Ovarian cancer is a serious risk to human health and causes a heavy economic burden. Ultrasound is widely used in the diagnosis of ovarian tumors. However, false-positive ultrasound results can lead to false diagnosis, and patients will have to bear unnecessary mental pain, expensive surgery and examination costs, surgical trauma, organ removal, loss of function, and even serious complications in the perioperative period, and other adverse consequences. False-negative ultrasound results lead to delayed treatment, and patients will have to bear the consequences of poor prognosis, high treatment costs, poor quality of life, and poor survival. There is an urgent need to find convenient, cost-effective and non-invasive diagnostic methods to reduce the false-negative and false-positive rates of ovarian ultrasound. The purpose of this study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in Ovarian cancer. Patients and methods: The study finally included 79 study subjects (malignant group, n=12; benign group, n=67). Remaining serum samples from the subjects were collected and tested by applying YiDiXie™ all-cancer detection kit to evaluate the sensitivity and specificity of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D, respectively. Results: YiDiXie™-SS had a sensitivity of 100% (95% CI: 75.8% - 100%) and a specificity of 61.2% (95% CI: 49.2% - 72.0%). YiDiXie™-HS had a sensitivity of 91.7% (95% CI: 64.6% - 99.6%) and a specificity of 86.6% (95% CI: 76.4% - 92.8%). The sensitivity of YiDiXie™-D was 33.3% (95% CI: 13.8% - 60.0%) and its specificity was 97.0% (95% CI: 89.8% - 99.5%). The sensitivity of YiDiXie™-SS in ultrasound-positive patients was 100% (95% CI: 67.6% - 100%) and its specificity was 61.9% (95% CI: 40.9% - 79.2%). This represents a 61.9% (95% CI: 40.9% - 79.2%) reduction in the rate of false-positive ovarian ultrasound with the application of YiDiXie™-SS with essentially no increase in malignant tumor under-diagnosis. The sensitivity of YiDiXie™-HS in ultrasound-negative patients was 75.0% (95% CI: 30.1% - 98.7%) and its specificity was 84.8% (95% CI: 71.8% - 92.4%). This means that the application of YiDiXie™-HS reduces the false negative rate of ultrasound by 75.0% (95% CI: 30.1% - 98.7%). YiDiXie™-D had a sensitivity of 25.0% (95% CI: 4.4% - 59.1%) in ultrasound-positive patients and its specificity was 95.2% (95% CI: 77.3% - 99.8%). This represents a 95.2% (95% CI: 77.3% - 99.8%) reduction in the rate of ultrasound false positives with YiDiXie™-SS. Conclusion: YiDiXie™-SS markedly reduced the false-positive rate of ovarian ultrasound with essentially no increase in delayed treatment of malignant tumors. YiDiXie™-HS substantially reduced the false-negative rate of ovarian ultrasound. YiDiXie™-D substantially reduced the false-positive rate of ovarian ultrasound. The YiDiXie™ test has an excellent diagnostic value in ovarian cancer, and promises to solve the problems of "high false-positive rate of ultrasound" and "high false-negative rate of ultrasound" in ovarian tumors. Clinical trial number: ChiCTR2200066840. Key words: Ovarian cancer, Ovary ultrasound, False-positive, False-negative, YiDiXie™-SS, YiDiXie™-HS, YiDiXie™-D