Evaluation of the diagnostic value of YiDiXie™-SS in breast ultrasound-positive patients

BackgroundBreast cancer is a serious threat to womens 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.