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

Background

Pancreatic cancer is a serious threat to human health. Enhanced CT is widely used in the diagnosis of pancreatic cancer. 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 pancreatic tumors. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in pancreatic cancer.

Patients and methods

62 subjects (malignant group, n=37; benign group, n=25) 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 100% (95% CI: 90.6% - 100%) and its specificity was 68.0% (95% CI: 48.4% - 82.8%). This means that YiDiXie™ SS has extremely high sensitivity and high specificity in pancreatic tumors.YiDiXie™-HS has a sensitivity of 94.6% (95% CI: 82.3% - 99.0%) and a specificity of 84.0% (95% CI: 65.3% - 93.6%). This means that YiDiXie™-HS has high sensitivity and specificity in pancreatic tumors.YiDiXie™-D has a sensitivity of 73.0% (95% CI: 57.0% - 84.6%) and its specificity is 92.0% (95% CI: 75.0% - 98.6%). This means that YiDiXie™-D has high sensitivity and very high specificity in pancreatic tumors.YiDiXie™ SS had a sensitivity of 100% (95% CI: 88.6% - 100%) and a specificity of 66.7% (95% CI: 30.0% - 94.1%) 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% (95% CI: 30.0% - 94.1%) with essentially no increase in malignancy leakage. YiDiXie™-HS had a sensitivity of 85.7% (95% CI: 48.7% - 99.3%) and a specificity of 84.2% (95% CI: 62.4% - 92.5%) in enhanced CT-negative patients. This means that YiDiXie™-HS reduces the false-negative enhancement CT rate by 84.2% (95% CI: 62.4% - 92.5%). YiDiXie™-D has a sensitivity of 73.3%(95% CI: 55.6% - 85.8%) and a specificity of 83.3%(95% CI: 43.6% - 99.1%) in patients with positive enhancement CT. This means that YiDiXie™-D reduces the false positive rate of enhanced CT by 83.3%(95% CI: 43.6% - 99.1%). YiDiXie™-D had a sensitivity of 71.4% (95% CI: 35.9% - 94.9%) and a specificity of 94.7% (95% CI: 75.4% - 99.7%) in patients with negative enhanced CT. This means that YiDiXie™-D reduces the false-negative rate of enhanced CT by 71.4% (95% CI: 35.9% - 94.9%) while maintaining high specificity.

Conclusion

YiDiXie ™ -SS has very high sensitivity and high specificity in pancreatic tumors.YiDiXie ™ -HS has high sensitivity and high specificity in pancreatic tumors.YiDiXie™-D has high sensitivity and very high specificity in pancreatic tumors.YiDiXie™ SS significantly reduces pancreatic-enhanced CT with essentially no increase in delayed treatment of malignant tumors. The YiDiXie™-HS significantly reduces the false negative rate of pancreatic enhanced CT. the YiDiXie™ -D significantly reduces the false positive rate of pancreatic enhanced CT or significantly reduces the false negative rate of pancreatic enhanced CT while maintaining a high level of specificity. the YiDiXie™ test is of great diagnostic value in pancreatic cancer, and it is expected to solve the problem of “ too high a false positive rate” and “ too high a false negative rate” of pancreatic enhanced CT.

Clinical trial number

ChiCTR2200066840.