Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS, and YiDiXie™-D in Ovarian cancer
Authors: Zhang Pengwu , Sun Chen , Ge Zhenjian , Chen Wenkang , Li Yingqi , Lin Shengjie , Wang Wuping , Chen Siwei , Wu Yutong , Zhou Huimei , Li Xutai , Li Wei , Lai Yongqing 
Published: September 2024

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 bring false diagnosis and wrong surgery or treatment, while false-negative ultrasound results bring missed diagnosis and delayed treatment. 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

The sensitivity of YiDiXie™-SS was 100% (95% CI: 75.8% - 100%) and its specificity was 61.2% (95% CI: 49.2% - 72.0%). This means that YiDiXie™ SS has very high sensitivity and high specificity in ovarian tumors. The sensitivity of YiDiXie™ -HS was 83.3% (95% CI: 55.2% - 97.0%) and its specificity was 86.6% (95% CI: 76.4% - 92.8%). This means that YiDiXie™-HS has high sensitivity and high specificity in ovarian tumors.The sensitivity of YiDiXie™-D was 66.7% (95% CI: 39.1% - 86.2%) and its specificity was 92.5% (95% CI: 83.7% - 96.8%). This means that YiDiXie™-D has high sensitivity and very high specificity in ovarian tumors. 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 means that the application of YiDiXie ™ SS reduces the rate of false-positive ovarian ultrasound by 61.9% (95% CI: 40.9% - 79.2%) with essentially no increase in malignant tumor underdiagnosis.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 62.5% (95% CI: 30.6% - 86.3%) and a specificity of 90.5% (95% CI: 71.1% - 98.3%) in ultrasound positive patients. This means that YiDiXie™-D reduces the false positive rate of ultrasound by 90.5% (95% CI: 71.1% - 98.3%).The sensitivity of YiDiXie™-D in ultrasound-negative patients was 75.0% (95% CI: 30.1% - 98.7%) and its specificity was 93.5% (95% CI: 82.5% - 97.8%). This means that YiDiXie™-D reduces the false-negative rate of ultrasound by 75.0% (95% CI: 30.1% - 98.7%) while maintaining high specificity.

Conclusion

YiDiXie™-SS provides extremely high sensitivity and relatively high specificity in ovarian tumors.YiDiXie™-HS provides high sensitivity and high specificity in ovarian tumors.YiDiXie™-D provides high sensitivity and extremely high specificity in ovarian tumors.YiDiXie™-SS significantly reduces false-positive rates on ovarian ultrasound with essentially no increase in delayed treatment of malignancies. YiDiXie™-HS significantly reduces the false-negative rate of ovarian ultrasound, and YiDiXie™-D can significantly reduce the false-positive rate of ovarian ultrasound or significantly reduce the false-negative rate of ovarian ultrasound while maintaining a high level of specificity. The YiDiXie ™ test has significant diagnostic value in ovarian cancer, and is expected to solve the two problems of the “too high false-positive rate” and the “too high false-negative rate” of ovarian ultrasound.

Clinical trial number

ChiCTR2200066840.