Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in esophageal cancer
Authors: Li Xutai , Ge Zhenjian , Liao Peng , Sun Chen , Chen Wenkang , Li Yingqi , Lin Shengjie , Zhang Pengwu , Wang Wuping , Chen Siwei , Wu Yutong , Zhou Huimei , Li Wei , Du Jing , Zhang Fangting , Lai Yongqing 
Published: September 2024

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 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 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, YiDiXie™ -HS and YiDiXie™-D 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 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.

Conclusion

YiDiXie™-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 number

ChiCTR2200066840.