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

BackgroundColorectal 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. However, false-positive results of FOBT, CEA, CA125, and CA19-9 can lead to misdiagnosis and wrong colorectaloscopy, 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 indicators. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in colorectal cancer.Patients and methodsThis 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, YiDiXie™-HS and YiDiXie™-D, respectively.ResultsThe sensitivity of YiDiXie™-SS was 99.0% (95% CI: 97.8% - 99.5%) and its specificity was 63.1% (95% CI: 57.6% - 68.2%). This means that YiDiXie ™ -SS has an extremely high sensitivity and relatively high specificity in colorectal tumors.YiDiXie™-HS has a sensitivity of 93.7% (95% CI: 91.5% - 95.4%) and a specificity of 86.3% (95% CI: 82.1% - 89.7%). This means that YiDiXie™-HS has high sensitivity and specificity in colorectal tumors.YiDiXie™-D has a sensitivity of 82.6% (95% CI: 79.3% - 85.4%) and a specificity of 93.9% (95% CI: 90.7% - 96.1%). This means that YiDiXie ™ -D has relatively high sensitivity and very high specificity in colorectal 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.ConclusionYiDiXie™-SS has very high sensitivity and relatively high specificity in colorectal tumors.YiDiXie™-HS has high sensitivity and high specificity in colorectal tumors.YiDiXie™-D has relatively high sensitivity and very high specificity in colorectal tumors. YiDiXie ™ -SS significantly reduced false-positive rates for FOBT, CEA, CA125, and CA19-9 with essentially no increase in delayed treatment for colorectal cancer.YiDiXie™-HS substantially reduced false-negative rates for 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 level of specificity. YiDiXie ™ tests have an important diagnostic value in colorectal cancer, and are expected to solve the problems of “high false-positive rate” and “high false-negative rate” of FOBT, CEA, CA125 and CA19-9.Clinical trial numberChiCTR2200066840.