Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in gallbladder cancer

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.