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

Background

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

Patients and methods

309 subjects (malignant group, n=244; benign group, n=65) 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, YiDiXie™-HS and YiDiXie™-D, respectively.

Results

The sensitivity of YiDiXie™SS was 98.4% (95.9% - 99.4%) and its specificity was 70.8% (58.8% - 80.4%). This means that YiDiXie™-SS has very high sensitivity and specificity in renal tumors.YiDiXie™-HS has a sensitivity of 85.2% (80.3% - 89.1%) and its specificity is 84.6% (73.9% - 91.4%). This means that YiDiXie™-HS has both the sensitivity and specificity in kidney tumors.YiDiXie™-D has a sensitivity of 72.5% (66.6% - 77.8%) and its specificity is 92.3% (83.2% - 96.7%). This means that YiDiXie™-D has high sensitivity and very high specificity in kidney tumors.YiDiXie™-SS had a sensitivity of 98.6% (95% CI: 95.8% - 99.6%) and a specificity of 71.4% (95% CI: 45.4% - 88.3%) in renal enhanced CT-positive patients. This means that the application of YiDiXie™-SS reduces the false-positive rate of renal enhanced CT by 71.4% (95% CI: 45.4% - 88.3%) with essentially no increase in malignant tumor leakage. The sensitivity of YiDiXie ™-HS in renal enhanced CT-negative patients was 86.5% (95% CI: 72.0% - 94.1%) and its specificity was 84.3% (95% CI: 72.0% - 91.8%). This means that the application of YiDiXie™-HS reduces the false-negative rate of enhanced CT by 86.5% (95% CI: 72.0% - 94.1%).The sensitivity of YiDiXie™-D in renal enhanced CT-positive patients was 31.9% (95% CI: 25.9% - 38.5%) and its specificity was 92.9% (95% CI: 68.5% - 99.6%). This means that YiDiXie™-D reduces the false positive rate of enhanced CT by 92.9% (95% CI: 68.5% - 99.6%). YiDiXie™-D had a sensitivity of 64.9% (95% CI: 48.8% - 78.2%) and a specificity of 92.2% (95% CI: 81.5% - 96.9%) in patients with negative enhanced CT. This means that YiDiXie™-D reduces the false-negative rate of enhanced CT by 64.9% (95% CI: 48.8% - 78.2%) while maintaining high specificity.

Conclusion

YiDiXie™-SS has very high sensitivity and high specificity in renal tumors. YiDiXie™-HS has high sensitivity and high specificity in renal tumors. YiDiXie™-D has high sensitivity and very high specificity in renal tumors. YiDiXie™-SS significantly reduces renal enhancement CT false-positive rates with essentially no increase in delayed treatment of malignant tumors. YiDiXie™-HS significantly reduces the false-negative rate of renal enhancement CT. YiDiXie™-D can significantly reduce the false-positive rate of renal enhancement CT or significantly reduce the false-negative rate while maintaining high specificity. the YiDiXie™test has important diagnostic value in renal cancer and is expected to solve the two problems of “too high false-positive rate” and “too high false-negative rate” of renal enhanced CT.

Clinical trial number

ChiCTR2200066840.