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

BackgroundLiver cancer is one of the cancers that consistently ranks among the top five cancers in terms of incidence and mortality in many countries. 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 rate of ultrasound and the false-negative and false-positive rates of enhanced CT for liver tumors. The purpose of this study is to evaluate the diagnostic value of YiDiXie™-HS, YiDiXie™-SS and YiDiXie™-D in liver tumors.Patients and methodsThis study finally included 217 subjects (the malignant group, n=185; the benign group, n=32). Remaining serum samples from the subjects were collected and tested using the YiDiXie™ all-cancer detection kit, which was applied to assess the sensitivity and specificity of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D, respectively.ResultsThe sensitivity of YiDiXie™-SS was 98.9% (96.1% - 99.8%) and its specificity was 68.8% (51.4% - 82.0%). This means that YiDiXie™-SS has very high sensitivity and high specificity in liver tumors.YiDiXie™-HS has a sensitivity of 88.1% (82.7% - 92.0%) and its specificity is 84.4% (68.2% - 93.1%). This means that YiDiXie™-HS has high sensitivity and high specificity in liver tumors.YiDiXie™-D has a sensitivity of 72.4% (65.6% - 78.4%) and its specificity is 93.8% (79.9% - 98.9%). This means that YiDiXie™-D has high sensitivity and very high specificity in liver tumors.YiDiXie™-SS has a sensitivity of 99.2% (95.8% - 100%) and a specificity of 66.7% (39.1% - 86.2%) in patients with positive enhanced CT. This means that the application of YiDiXie™-SS reduces the false-positive rate of enhanced CT by 66.7% (39.1% - 86.2%) with essentially no increase in the leakage of malignant tumors.YiDiXie™-HS has a sensitivity of 89.1% (95% CI: 78.2% - 94.9%) in patients with a negative enhanced CT, and its specificity is 85.0% (64.0% - 94.8%). This means that YiDiXie™-HS reduces the false-negative rate of enhanced CT by 85.0% (64.0% - 94.8%). YiDiXie™-D has a sensitivity of 73.1% (64.9% - 80.0%) and a specificity of 91.7% (64.6% - 99.6%) in patients with positive enhanced CT. This means that YiDiXie™-D reduces the false-positive rate of enhanced CT by 91.7% (64.6% - 99.6%). YiDiXie™-D has a sensitivity of 70.9% (95% CI: 57.9% - 81.2%) and a specificity of 95.0% (95% CI: 76.4% - 99.7%) in patients with negative enhanced CT. This means that YiDiXie ™ -D reduces the false-negative rate of enhanced CT by 70.9% (95% CI: 57.9% - 81.2%) while maintaining high specificity.ConclusionYiDiXie™-SS has very high sensitivity and high specificity in liver tumors. YiDiXie™-HS has high sensitivity and high specificity in liver tumors. YiDiXie™-D has high sensitivity and very high specificity in liver tumors. YiDiXie™-SS significantly reduces the false positive rate of liver-enhanced CT with essentially no increase in delayed treatment of malignant tumors. YiDiXie™-HS significantly reduces the false-negative rate of enhanced CT. YiDiXie™-D can significantly reduce the false-positive rate of enhanced CT or significantly reduce the false-negative rate of enhanced CT while maintaining a high specificity. The YiDiXie™ test has significant diagnostic value in liver tumors, and is expected to solve the problems of “high false-positive rate” and “high false-negative rate” of enhanced CT in liver tumors.Clinical trial numberChiCTR2200066840.