Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in esophageal cancer

BackgroundEsophageal cancer is a serious threat to human health and causes a heavy economic burden. upper gastrointestinal imaging(UGI imaging), enhanced CT, Fecal occult blood Tumor markers such as test(FOBT) and CEA, CA125 and CA19-9 are widely used in the screening or preliminary diagnosis of esophageal cancer. However, false-positive results of UGI imaging, enhanced CT, FOBT, CEA, CA125, and CA19-9 can lead to misdiagnosis and erroneous esophagoscopy, while their false-negative results can lead to missed diagnosis and delayed treatment. It is urgent to find a convenient, economical and non-invasive diagnostic method to reduce the false positive rate and false negative rate of UGI imaging. The objective of this study was to evaluate the diagnostic value of YiDiXie-SS, YiDiXie -HS and YiDiXie-D in esophageal cancer. Patients and methodsThis study included 164 subjects (malignant group, n=105; Benign group, n=59 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 YiDiXieall-cancer detection kit. ResultsThe sensitivity of YiDiXie-SS was 99.0% (95% CI: 94.8% - 100%) and its specificity was 61.0% (95% CI: 48.3% - 72.4%). This means that YiDiXie-SS has an extremely high sensitivity and relatively high specificity in esophageal tumors.YiDiXie -HS has a sensitivity of 92.3% (95% CI: 85.7% - 96.1%) and a specificity of 86.4% (95% CI: 75.5% - 93.0%). This means that YiDiXie-HS has high sensitivity and specificity in esophageal tumors.YiDiXie-D has a sensitivity of 83.8% (95% CI: 75.6% - 89.6%) and a specificity of 93.2% (95% CI: 83.8% - 97.3%). This means that YiDiXie-D has relatively high sensitivity and very high specificity in esophageal tumors. YiDiXie-SS significantly reduced the false-positive rate of UGI imaging, CT, FOBT, CEA, CA125, CA19-9 with essentially no increase in malignancy leakage.YiDiXie-HS significantly reduced the false-negative rate of UGI imaging, CT, FOBT, CEA, CA125, CA19-9. YiDiXie-D significantly reduces the false positive rate of UGI imaging, CT, FOBT, CEA, CA125, CA19-9. YiDiXie-D significantly reduces the false negative rate of UGI imaging, CT, FOBT, CEA, CA125, CA19-9, while maintaining a high level of specificity. ConclusionYiDiXie-SS has very high sensitivity and relatively high specificity in esophageal tumors.YiDiXie-HS has high sensitivity and high specificity in esophageal tumors.YiDiXie -D has relatively high sensitivity and very high specificity in esophageal tumors. YiDiXie-SS significantly reduced the false-positive rates of UGI imaging, CT, FOBT, CEA, CA125, and CA19-9 with essentially no increase in delayed treatment for esophageal cancer. YiDiXie -HS substantially reduced the false-negative rates of UGI imaging, CT, FOBT, CEA, CA125, and CA19-9. YiDiXie -D significantly reduces the false-positive rate of UGI imaging, CT, FOBT, CEA, CA125, CA19-9, or significantly reduces their false-negative rates while maintaining high specificity. YiDiXie tests have an important diagnostic value in esophageal cancer, and are expected to solve the problems of "high false-positive rate" and "high false-negative rate" of UGI imaging, CT, FOBT, CEA, CA125, CA19-9. Clinical trial numberChiCTR2200066840.