Evaluation of the diagnostic value of YiDiXie™-SS and YiDiXie™-HS in gastric cancer

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 and other markers will cause needless mental suffering, costly examination costs, examination injuries, and other unfavorable consequences. False-negative results of FOBT and other markers will cause treatment to be delayed, which will force patients to suffer from a poor prognosis, high treatment costs, a low quality of life, and a short survival period. 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 and YiDiXie™-HS 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 and YiDiXie™-HS were evaluated using the YiDiXie™ all-cancer detection kit. Results: The sensitivity of YiDiXie™-SS in patients with positive FOBT, CEA, CA125, and CA19-9 were 100% (95% CI: 77.2%-100%), 96.7% (95% CI: 83.3% - 99.8%), 95.5% (95% CI: 78.2%- 99.8%), 97.1% (95% CI: 85.1%- 99.8%); The Specificity degrees were 75.0% (95% CI: 30.1%- 98.7%), 73.3% (95% CI: 48.0%- 89.1%), 66.7% (95% CI: 30.0%- 94.1%), 66.7% (95% CI: 35.4%-87.9%). This means that the application of YiDiXie™-SS, without basically increasing the missed diagnosis of malignant tumors, reduced the false-positive rates of FOBT, CEA, CA125, and CA19-9 by 75.0% (95% CI: 30.1%-98.7%), 73.3% (95% CI: 48.0% - 89.1%), 66.7% (95% CI: 30.0% -94.1%), 66.7% (95% CI: 35.4% -87.9%). The sensitivity of YiDiXie™-HS in FOBT, CEA, CA125, and CA19-9 negative patients was 96.5% (95%CI: 90.2-99.0%) and 96.8% (95%CI: 93.2% - 98.5%), 97.3% (95% CI: 93.8%- 98.8%), 96.7% (95% CI: 93.0%- 98.5%); The specific degrees were 86.4% (95% CI: 66.7%- 95.3%), 89.3% (95% CI: 85.7%- 92.1%), 89.5% (95% CI: 84.6%- 93.0%), 90.4% (95% CI: 86.8%-93.1%). This means that YiDiXie™-HS reduced false-negatives for FOBT, CEA, CA125, and CA19-9 by 96.5% (95% CI: 90.2% to 99.0%) and 96.8% (95% CI: 93.2% - 98.5%), 97.3% (95% CI: 93.8%- 98.8%), 96.7% (95% CI: 93.0%- 98.5%). Conclusion: YiDiXie™-SS significantly reduced false-positive rates of FOBT, CEA, CA125 and CA19-9 without substantially increasing delayed treatment of malignant tumors. YiDiXie™-HS significantly reduced false-negative rates for FOBT, CEA, CA125 and CA19-9. YiDiXie™-SS and YiDiXie™-HS have important diagnostic value in gastric cancer, and are expected to solve the two problems of "high false-positive rate of FOBT and other markers" and "high false-negative rate of FOBT and other markers" in gastric cancer. Clinical Research Registration Number:ChiCTR2200066840. Keywords: Gastric cancer, Fecal occult blood test, CEA, CA125, CA19-9, False-positive, False-negative, YiDiXie™-SS, YiDiXie™-HS