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

Background: Colorectal 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 colorectal cancer screening and initial diagnosis. False-negative results of FOBT and other indicators, on the other hand, 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. False-positive results of FOBT and other indicators, however, will cause needless mental suffering, costly examination costs, examination injuries, and other unfavorable consequences. Finding practical, affordable, and non-invasive diagnostic techniques is crucial to lowering the false-positive and false-negative rates of FOBT and other indicators. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS and YiDiXie™-HS in colorectal cancer. Patients and methods: This study eventually included 916 participants (602 in the malignant group and 314 in the benign group). Serum samples from individuals were obtained and examined using the YiDiXie™ all-cancer detection kit to assess the sensitivity and specificity of YiDiXie™-SS and YiDiXie™-HS, respectively. Results: The sensitivity of YiDiXie™-SS was 99.0% (95% CI: 96.6% - 99.8%), 99.0% (95% CI: 96.4% - 99.8%), 100% (95% CI: 89.8% - 100%) and 98.6% (95% CI: 92.5% - 99.9%) in FOBT, CEA, CA125, and CA19-9 positive patients; and its specificity was 63.6% (95% CI: 43.0% - 80.3%), 65.0% (95% CI: 43.3% - 81.9%), 60.0% (95% CI: 23.1% - 92.9%) and 66.7% (95% CI: 35.4% - 87.9%), respectively. YiDiXie™-SS reduced false positives for FOBT, CEA, CA125, and CA19-9 by 63.6% (95% CI: 43.0% - 80.3%), 65.0% (95% CI: 43.3% - 81.9%), 60.0% (95% CI: 23.1% - 92.9%) and 66.7% (95% CI: 35.4% - 87.9%). YiDiXie™-HS demonstrated a sensitivity of 94.5% (95% CI: 87.8% - 97.6%), 93.7% (95% CI: 90.8% - 95.8%), 94.5% (95% CI: 92.2% - 96.2%) and 93.9% (95% CI: 91.5% - 95.7%) in FOBT, CEA, CA125, and CA19-9 negative patients, respectively; their specificities were 87.5% (95% CI: 69.0% - 95.7%), 86.7% (95% CI: 82.3% - 90.1%), 84.9% (95% CI: 79.1% - 89.3%) and 85.7% (95% CI: 81.1% - 89.3%). This indicates that 94.5% (95% CI: 87.8% - 97.6%), 93.7% (95% CI: 90.8% - 95.8%), 94.5% (95% CI: 92.2% - 96.2%) and 93.9% (95% CI: 91.5% - 95.7%) of false negatives for FOBT, CEA, CA125, and CA19-9 were reduced by YiDiXie™-HS, respectively. Conclusion: YiDiXie™-SS lowers false-positive rates for FOBT, CEA, CA125, and CA19-9, with no increase in delayed treatment of malignant tumors. YiDiXie™-HS dramatically reduces false-negative rates for FOBT, CEA, CA125, and CA19-9. YiDiXie™-SS and YiDiXie™-HS offer significant diagnostic value in colorectal cancer and are predicted to address the two challenges of "high false-positive rate of FOBT and other indicators" and "high false-negative rate of FOBT and other indicators" in colorectal cancer. Clinical Research Registration Number:ChiCTR2200066840. Keywords: Colorectal cancer, Fecal occult blood test, CEA, CA125, CA19-9, False-positive, False-negative, YiDiXie™-SS, YiDiXie™-HS