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

Background

Uroepithelial carcinoma is a serious threat to human health and causes heavy economic burden. Enhanced CT is widely used in screening or preliminary diagnosis of uroepithelial tumors. However, false-positive results on enhanced CT can lead to misdiagnosis and incorrect endoscopy, while false-negative results on enhanced CT 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-negative and false-positive rates of enhanced CT in uroepithelial tumors. The aim of this study was to evaluate the diagnostic value of YiDiXie ™ -SS, YiDiXie ™ -HS and YiDiXie ™ -D in uroepithelial carcinoma.

Patients and methods

319 subjects (malignant group, n=240; benign group, n=79) were finally included in this study. Remaining serum samples from the subjects were collected and tested by applying the YiDiXie™ all-cancer detection kit to evaluate the sensitivity and specificity of YiDiXie™-SS and YiDiXie™-HS.

Results

The sensitivity of YiDiXie™ SS was 95.8% (95% CI: 92.5% - 97.7%) and its specificity was 64.6% (95% CI: 53.6% - 74.2%). This means that YiDiXie ™ -SS has an extremely high sensitivity and relatively high specificity in urothelial tumors.YiDiXie™-HS has a sensitivity of 85.8% (95% CI: 80.9% - 89.7%) and a specificity of 84.8% (95% CI: 75.3% - 91.1%). This means that YiDiXie™-HS has high sensitivity and specificity in urothelial tumors.YiDiXie™-D has a sensitivity of 73.3% (95% CI: 67.4% - 78.5%) and a specificity of 92.4% (95% CI: 84.4% - 96.5%). This means that YiDiXie ™ -D has relatively high sensitivity and very high specificity in urothelial tumors. The sensitivity of YiDiXie™-SS in enhanced CT-positive patients was 96.3% (95% CI: 96.3% - 98.3%)and its specificity was 64.3% (95% CI: 38.8% - 83.7%). This means that the application of YiDiXie™-SS reduces the false-positive rate of urological enhanced CT by 64.3% (95% CI: 38.8% - 83.7%) with essentially no increase in malignancy leakage. The sensitivity of YiDiXie™-HS in enhanced CT-negative patients was 85.5% (95% CI: 75.9% - 91.7%)and its specificity was 84.6% (95% CI: 73.9% - 91.4%). This means that the application of YiDiXie™-HS reduces the false-negative rate of urological enhanced CT by 85.5% (95% CI: 75.9% - 91.7%).YiDiXie™-D had a sensitivity of 75.6% (95% CI: 68.5% - 81.5%) and a specificity of 92.9% (95% CI: 68.5% - 99.6%) in patients with enhanced CT positivity. This means that YiDiXie ™ -D reduced the rate of false positives in enhanced CT by 92.9% (95% CI: 87.8% - 96.0%). YiDiXie ™ -D has a sensitivity of 68.4% (95% CI: 57.3% - 77.8%) and a specificity of 92.3% (95% CI: 83.2% - 96.7%) in patients with enhanced CT negativity. This means that YiDiXie™-D reduces the false-negative rate of enhanced CT by 68.4% (95% CI: 57.3% - 77.8%) while maintaining high specificity.

Conclusion

YiDiXie™-SS has extremely high sensitivity and relatively high specificity in urological tumors. YiDiXie™-HS has high sensitivity and high specificity in urological tumors. YiDiXie™-D has relatively high sensitivity and extremely high specificity in urological tumors. YiDiXie ™ -SS dramatically reduces urological enhanced CT false-positive rates with essentially no increase in delayed treatment of malignant tumors. YiDiXie™-HS substantially reduces urological enhanced CT false-negative rates.YiDiXie ™ -D substantially reduces urological enhanced CT false-positive rates, or significantly reduces urological enhanced CT false-negative rates while maintaining high specificity. YiDiXie™ tests has important diagnostic value in uroepithelial cancer, and is expected to solve the problems of “high false positive rate” and “high false negative rate” of urological enhanced CT.

Clinical trial number

ChiCTR2200066840.