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

Background

Gastric cancer poses a severe risk to public health and has a substantial financial impact. Tumor markers such as CEA, CA125, CA19-9, and others, as well as the fecal occult blood test (FOBT), are frequently utilized for gastric cancer screening and initial diagnosis. However, false-positive results of FOBT, CEA, CA125, and CA19-9 can lead to misdiagnosis and erroneous gastroscopy, while their false-negative results can lead to missed diagnosis and delayed treatment. Finding practical, affordable, and non-invasive diagnostic techniques is crucial to lowering the false-positive and false-negative rates of FOBT and other markers. The aim of this study was to evaluate the diagnostic value of YiDiXie ™-SS, YiDiXie™-HS and YiDiXie™-D in gastric cancer.

Patients and methods

This study included 602 subjects (Malignant group, n=222; Benign group, n=380 cases). The remaining serum samples of the subjects were collected and the sensitivity and specificity of the YiDiXie™-SS, YiDiXie™ -HS and YiDiXie™-D were evaluated using the YiDiXie™ all-cancer detection kit.

Results

The sensitivity of YiDiXie™-SS was 99.5% (95% CI: 97.5% - 100%) and its specificity was 64.5% (95% CI: 59.5% - 69.1%). This means that YiDiXie™-SS has an extremely high sensitivity and relatively high specificity in gastric tumors.YiDiXie™-HS has a sensitivity of 96.8% (95% CI: 93.6% - 98.5%) and a specificity of 89.5% (95% CI: 86.0% - 92.2%). This means that YiDiXie™ -HS has high sensitivity and high specificity in gastric tumors. The sensitivity of YiDiXie™-D was 83.3% (95% CI: 77.9% - 87.7%) and its specificity was 95.5% (95% CI: 93.0% - 97.2%). This means that YiDiXie™-D has relatively high sensitivity and very high specificity in gastric tumors. YiDiXie™-SS significantly reduced the false-positive rates of FOBT, CEA, CA125, and CA19-9 with essentially no increase in malignancy leakage.YiDiXie™-HS substantially reduced the false-negative rates of FOBT, CEA, CA125, and CA19-9. YiDiXie™-D significantly reduces the false positive rate of FOBT, CEA, CA125, CA19-9. YiDiXie™-D significantly reduces the false negative rate of FOBT, CEA, CA125, CA19-9 while maintaining a high level of specificity.

Conclusion

YiDiXie™-SS has very high sensitivity and relatively high specificity in gastric tumors.YiDiXie™-HS has high sensitivity and high specificity in gastric tumors.YiDiXie ™ -D has relatively high sensitivity and very high specificity in gastric tumors. YiDiXie ™ -SS significantly reduces the false-positive rates of FOBT, CEA, CA125, and CA19-9 with essentially no increase in delayed treatment of gastric cancer.YiDiXie™-HS significantly reduces the false-negative rates of FOBT, CEA, CA125, and CA19-9.YiDiXie™-D can significantly reduce the false-positive rate of FOBT, CEA, CA125 and CA19-9, or significantly reduce the false-negative rate of FOBT, CEA, CA125 and CA19-9 while maintaining a high degree of specificity. YiDiXie™ test has an important diagnostic value in gastric cancer, and is expected to solve the problems of “high false positive rate” and “high false negative rate” of FOBT, CEA, CA125 and CA19-9.