Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in breast cancer
Authors: Wu Yutong , Zhou Huimei , Li Xutai , Sun Chen , Ge Zhenjian , Chen Wenkang , Li Yingqi , Lin Shengjie , Zhang Pengwu , Wang Wuping , Chen Siwei , Li Wei , Hu Hui , Liu Xiaoling , Lai Yongqing 
Published: July 2024

BackgroundBreast cancer is a serious threat to women’s health and breast cancer screening is of great importance. Breast ultrasound or mammography is widely used for screening or diagnosis of breast tumors, However, false-positive breast ultrasound or mammogram results can lead to misdiagnosis and wrong puncture biopsy, while false-negative breast ultrasound or mammogram results can lead to missed diagnosis and delayed treatment. There is an urgent need to find a convenient, cost-effective and noninvasive method to reduce the false-positive rate and the false-negative rate of breast ultrasound or mammography. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in breast cancer.Patients and methods816 subjects (malignant group, n=778; benign tumor group, n=38) were finally included in this study. The remaining serum samples were collected and tested by YiDiXie™ all-cancer detection kit. The sensitivity and specificity of YiDiXie™ tests were evaluated respectively.ResultsThe sensitivity of YiDiXie™-SS was 97.8% (95% CI: 96.5% - 98.6%) and its specificity was 63.2% (95% CI: 47.3% - 76.6%). This means that YiDiXie™-SS has an extremely high sensitivity and relatively high specificity in breast tumors.YiDiXie™-HS has a sensitivity of 84.4% (95% CI: 81.7% - 86.8%) and a specificity of 86.8% (95% CI: 72.7% - 94.2%). This means that YiDiXie™-HS has high sensitivity and specificity in breast tumors.YiDiXie™-HS has a sensitivity of 73.8% (95% CI: 70.6% - 76.7%) and a specificity of 94.7% (95% CI: 82.7% - 99.1%). This means that YiDiXie™-D has relatively high sensitivity and very high specificity in breast tumors. The sensitivity of YiDiXie™-SS in ultrasound and mammography-positive patients was 97.8% (95% CI: 96.5% - 98.7%), 97.6% (95% CI: 95.8% - 98.6%), and the specificity was 63.6% (95% CI. 46.6% - 77.8%), 58.3% (95% CI: 32.0% - 80.7%), respectively. This means that the application of YiDiXie™-SS reduced ultrasound and mammography false-positive rates by 63.6% (95% CI: 46.6% - 77.8%) and 58.3% (95% CI: 32.0% - 80.7%), respectively, with essentially no increase in the leakage of malignant tumors. The sensitivity of YiDiXie™-HS in ultrasound and mammography-negative patients was 84.8% (95% CI: 69.1% - 93.9%), 85.7% (95% CI: 76.7% - 91.6%), and the specificity was 60.0% (95% CI. 23.1% - 92.9%), 80.0% (95% CI: 37.6% - 99.0%), respectively. This means that the application of YiDiXie™-HS reduced the false-negative rates of ultrasound and mammography by 84.8% (95% CI: 69.1% - 93.9%), 85.7% (95% CI: 76.7% - 91.6%), respectively. The sensitivity of YiDiXie™-D in ultrasound and mammography-positive patients was 74.0% (95% CI: 70.8% - 77.0%), 76.9% (95% CI: 73.0% - 80.4%), and the specificity was 93.9% (95% CI. 80.4% - 98.9%), 91.7% (95% CI: 64.6% - 99.6%), respectively. This means that YiDiXie™-D reduced the false positive rate of ultrasound and mammography by 93.9% (95% CI: 80.4% - 98.9%), 91.7% (95% CI: 64.6% - 99.6%), respectively. The sensitivity of YiDiXie™ -D in ultrasound and mammography-negative patients was 72.7% (95% CI: 55.8% - 84.9%), 75.0% (95% CI: 64.8% - 83.0%), and its specificity was 100% (95% CI. 56.6% - 100%), 100% (95% CI: 56.6% - 100%), respectively. This means that YiDiXie™-D reduces the false negative rate of ultrasound and mammography by 72.7% (95% CI: 55.8% - 84.9%) and 75.0% (95% CI: 64.8% - 83.0%), respectively, while maintaining a high specificity.ConclusionYiDiXie™-SS has extremely high sensitivity and relatively high specificity in breast tumors.YiDiXie™-HS has high sensitivity and high specificity in breast tumors.YiDiXie™-D has relatively high sensitivity and extremely high specificity in breast tumors.YiDiXie™-SS significantly reduces the rate of false positives by breast ultrasound or mammography with essentially no increase in delayed treatment of breast cancer. YiDiXie™-HS significantly reduces the rate of false negatives on breast ultrasound or mammograms.YiDiXie™-D significantly reduces the rate of false positives on breast ultrasound or mammograms or significantly reduces the rate of false negatives while maintaining a high level of specificity. YiDiXie™ tests has significant diagnostic value in breast cancer and is expected to solve the problems of “high false positive rate” and “high false negative rate” of breast ultrasound or mammography.