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

BackgroundGallbladder cancer is a grave threat to human health and poses a severe economic burden. Enhanced CT is extensively used in the diagnosis of gallbladder 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 urgency to find convenient, cost-effective and noninvasive diagnostic methods to decrease the false-positive and false-negative rates of gallbladder-enhanced CT. The goal of this study was to assess the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in gallbladder cancer.Patients and methodsFifty study subjects (malignant group, n=12; benign group, n=38 cases) were finally recruited in the study. Remaining serum samples from the subjects were collected and tested by applying YiDiXie ™ all-cancer detection kit (YiDiXie™ all-cancer detection kit) to assess the sensitivity and specificity of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D, respectively.ResultsThe sensitivity of YiDiXie™ SS was 100% (95% CI: 75.8% - 100%) and its specificity was 65.8% (95% CI: 49.9% - 78.8%). This means that YiDiXie™ SS has very high sensitivity and high specificity in gallbladder tumors.The sensitivity of YiDiXie™-HS was 83.3% (95% CI: 55.2% - 97.0%) and its specificity was 84.2% (95% CI: 69.6% - 92.6%). This means that YiDiXie™-HS has high sensitivity and high specificity in gallbladder tumors.The sensitivity of YiDiXie™-D was 66.7% (95% CI: 39.1% - 86.2%) and its specificity was 92.1% (95% CI: 79.2% - 97.3%). This means that YiDiXie ™ -D has high sensitivity and very high specificity in gallbladder tumors. The sensitivity of YiDiXie™-SS in patients with positive enhanced CT was 100% (95% CI: 64.6% - 100%), and its specificity was 60.0% (95% CI: 31.3% - 83.2%). It implies that the application of YiDiXie™-SS reduces the false-positive rate of gallbladder-enhanced CT by 60.0% (95% CI: 31.3% - 83.2%) without essentially increasing the leakage of malignancies. The sensitivity of YiDiXie™-HS in enhanced CT-negative patients was 80.0% (95% CI: 37.6% - 99.0%) and its specificity was 85.7% (95% CI: 68.5% - 94.3%). It implies that the application of YiDiXie ™ -HS lowers the false-negative rate of enhanced CT by 80.0% (95% CI: 37.6% - 99.0%). The sensitivity of YiDiXie™-D in patients with positive enhanced CT was 71.4%(95% CI: 35.9% -94.9%) and its specificity was 90.0%(95% CI: 59.6% - 99.5%). It implies that YiDiXie™-SS lowers the false-positive rate of enhanced CT for 90.0%(95% CI: 59.6% - 99.5%). YiDiXie™-D has a sensitivity of 60.0% (95% CI: 23.1% - 92.9%) in patients with negative enhanced CT and its specificity is 92.9% (95% CI: 77.4% - 98.7%). This means that YiDiXie™-D reduces the false-negative rate of enhanced CT by 60.0% (95% CI: 23.1% - 92.9%) while maintaining high specificity.ConclusionYiDiXie ™ -SS has very high sensitivity and high specificity in gallbladder tumors.YiDiXie ™ -HS has high sensitivity and high specificity in gallbladder tumors.YiDiXie ™ -D has high sensitivity and very high specificity in gallbladder tumors.YiDiXie™ -SS significantly reduced gallbladder enhanced CT false-positive rates with essentially no increase in delayed treatment for gallbladder cancer. YiDiXie ™ -HS significantly reduces the false-negative rate of gallbladder enhanced CT. YiDiXie™ -D can significantly reduce the false-positive rate of gallbladder enhanced CT, or significantly reduce the false-negative rate of gallbladder enhanced CT while maintaining a high level of specificity.Clinical trial numberChiCTR2200066840.