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

Background: Esophageal 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 such as UGI imaging will bring unnecessary mental pain, expensive examination costs, examination injuries and other adverse consequences. However, false negative results such as UGI imaging lead to delayed treatment, and patients will have to bear the adverse consequences of poor prognosis, high treatment costs, poor quality of life, and short survival time. It is urgent to find a convenient, economical and non-invasive diagnostic method to reduce the false negative rate and false positive rate of UGI imaging. The objective of this study was to evaluate the diagnostic value of YiDiXie™-SS and YiDiXie™-HS in esophageal cancer. Patients and methods: This 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 and YiDiXie™-HS were evaluated using the YiDiXie™all-cancer detection kit. Results: The sensitivity of YiDiXie™-SS was 99.0% (95% CI: 94.8% - 100%) and its specificity was 62.7% (95% CI: 50.0% - 73.9%). The sensitivity of YiDiXie™-HS was 92.3% (95% CI: 85.7% - 96.1%) and its specificity was 86.4% (95% CI: 75.5% - 93.0%). The sensitivity of YiDiXie™-SS in UGI imaging, enhanced CT, FOBT, CEA, CA125 and CA19-9 positive patients was 96.6% (95% CI: 82.8-99.8%) and 98.7% (95% CI: 93.1% - 99.9%), 100% (95% CI: 17.8% 100%), 100% (95% CI: 81.6% 100%), 100% (95% CI: 61.0% 100%), 100% (95%CI: 56.6%-100%); The specific degrees were 60.0% (95% CI: 23.1% 92.9%), 75.0% (95% CI: 30.1% 98.7%), 100% (95% CI: 5.1% 100%), 100% (95% CI: 43.9% - 100%), 100% (95% CI: 5.1% 100%), 50.0% (95% CI: 2.6% 97.4%). This means that the application of YiDiXie™-SS, without basically increasing the missed diagnosis of malignant tumors, reduced the false positive range of UGI imaging, enhanced CT, FOBT, CEA, CA125 and CA19-9 by 60.0% (95% CI: 23.1% - 92.9%), 75.0% (95% CI: 30.1% 98.7%), 100% (95% CI: 5.1% 100%), 100% (95% CI: 43.9% 100%), 100% (95% CI: 5.1% - 100%), 50.0% (95% CI: 2.6% 97.4%). The sensitivity of YiDiXie™-HS in UGI imaging, enhanced CT, FOBT, CEA, CA125 and CA19-9 negative patients was 88.9% (95% CI: 56.5% - 99.4%), 92.6% (95% CI: 84.8% - 96.6%), 96.9% (95% CI: 84.3% - 99.8%), 92.6% (95% CI: 84.8% - 96.6%), 92.0% (95% CI: 84.5% - 96.1%), 91.3% (95% CI: 83.8% - 95.5%), respectively; The specific degrees were 60.0% (95% CI: 23.1% 92.9%), 87.3% (95% CI: 76.0% 93.7%), 80.0% (95% CI: 37.6% 99.0%), 89.1% (95% CI: 78.2% - 94.9%), 79.3% (95% CI: 61.6% 90.2%), 87.0% (95% CI: 75.6% 93.6%). This means that YiDiXie™-HS reduced false negatives for UGI imaging, enhanced CT, FOBT, CEA, CA125 and CA19-9 by 88.9% (95% CI: 56.5% - 99.4%), 92.6% (95% CI: 84.8% 96.6%), 96.9% (95% CI: 84.3% 99.8%), 92.6% (95% CI: 84.8% 96.6%), 92.0% (95% CI: 84.5% - 96.1%), 91.3% (95% CI: 83.8% 95.5%). Conclusion: YiDiXie™-SS significantly reduced the false-positive rate of UGI imaging, enhanced CT, FOBT, CEA, CA125 and CA19-9 without substantially increasing the delayed treatment of malignant tumors. YiDiXie™-HS significantly reduced false negative rates for UGI imaging, enhanced CT, FOBT, CEA, CA125 and CA19-9. YiDiXie™-SS and YiDiXie™-HS have important diagnostic value in esophageal cancer, and are expected to solve the two problems of "too high false positive rate such as UGI imaging" and "too high false negative rate such as UGI imaging" in esophageal cancer. Clinical trial number: ChiCTR2200066840. Key words: Esophageal cancer, UGI imaging, enhanced CT, Fecal occult blood test, CEA, CA125, CA15-3, CA19-9, False-positive, False-negative, YiDiXie™-SS, YiDiXie™-HS