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

Background

Endometrial cancer represents a significant challenge to human health and is associated with a considerable economic burden. Ultrasound is a commonly employed modality in the screening and preliminary diagnosis of endometrial cancer. However, false-positive uterine ultrasound results can lead to misdiagnosis and incorrect diagnostic curettage, while false-negative uterine ultrasound results can lead to missed diagnosis and delayed treatment. There is an urgent need to find convenient, cost-effective and non-invasive diagnostic methods to reduce the false-positive and false-negative rates of uterine ultrasound. The aim of the present study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in endometrial cancer.

Patients and methods

The final number of study subjects included in this study was 74, comprising 58 cases of malignant disease and 16 cases of benign disease. The remaining serum samples from the subjects were collected and tested using the YiDiXie™ all-cancer detection kit, with the objective of evaluating the sensitivity and specificity of the YiDiXie™-SS, YiDiXie™-HS and YiDiXie ™-D, respectively.

Results

The sensitivity of YiDiXie™-SS was 98.3% (95% CI: 90.9% - 99.9%) and its specificity was 62.5% (95% CI: 38.6% - 81.5%). This means that YiDiXie™-SS has an extremely high sensitivity and relatively high specificity in endometrial tumors.YiDiXie™-HS has a sensitivity of 82.8% (95% CI: 71.1% - 90.4%) and a specificity of 81.3% (95% CI: 57.0% - 93.4%). This means that YiDiXie™-HS has high sensitivity and specificity in endometrial tumors.YiDiXie™-D has a sensitivity of 70.7% (95% CI: 50.0% - 80.8%) and a specificity of 93.8% (95% CI: 71.7% - 99.7%). This means that YiDiXie™-D has relatively high sensitivity and very high specificity in endometrial tumors. The sensitivity of YiDiXie™-SS in patients with a positive uterine ultrasound was 95.0% (95% CI: 76.4% - 99.7%), while the specificity was 75.0% (95% CI: 30.1% - 98.7%). This indicates that the utilisation of YiDiXie ™-SS has the potential to reduce the incidence of false-positive uterine ultrasound results by 75.0% (95% CI: 30.1% - 98.7%), while simultaneously minimising the likelihood of malignancy leakage. The YiDiXie™-HS in patients with a negative uterine ultrasound was 81.6% (95% CI: 66.6% - 90.8%), while the specificity was 83.3% (95% CI: 55.2% - 97.0%). This suggests a reduction of 81.6% (95% CI: 66.6% - 90.8%) in the rate of false-negative uterine ultrasound with the application of YiDiXie™-HS. The sensitivity of YiDiXie™-D in uterine ultrasound positive patients was 75.0% (95% CI: 53.1% - 88.8%) and its specificity was 100% (95% CI: 51.0% - 100%). This means that YiDiXie™-D reduces the rate of false-positive uterine ultrasound by 100% (95% CI: 51.0% - 100%). YiDiXie™-D has a sensitivity of 68.4% (95% CI: 52.5% - 80.9%) and a specificity of 91.7% (95% CI: 64.6% - 99.6%) in patients with negative uterine ultrasound. This means that YiDiXie™-D reduces the false-negative rate of uterine ultrasound by 68.4% (95% CI: 52.5% - 80.9%) while maintaining high specificity.

Conclusion

YiDiXie™-SS has extremely high sensitivity and relatively high specificity in endometrial tumors.YiDiXie™-HS has high sensitivity and high specificity in endometrial tumors.YiDiXie™-D has relatively high sensitivity and extremely high specificity in endometrial tumors.YiDiXie™-SS has substantially reduced the rate of false positives on uterine ultrasound with essentially no increase in delayed treatment of endometrial cancer. YiDiXie ™ -HS significantly reduces the false negative rate of uterine ultrasound. YiDiXie™-D significantly reduces the false positive rate of uterine ultrasound or significantly reduces the false negative rate of uterine ultrasound while maintaining a high level of specificity. YiDiXie ™ tests are of significant diagnostic value in endometrial cancer, and are expected to solve the problem of the “high false positive rate” and “high false negative rate” of uterine ultrasound.

Clinical trial number

ChiCTR2200066840.