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

Abstract

Background: Breast cancer is a serious threat to women's health and breast cancer screening is of great importance. Ultrasound scan is widely used for screening or preliminary diagnosis of breast tumors, but its large number of false-positive results brings unnecessary mental pain, expensive examination costs, physical injury and other adverse consequences. There is an urgent need to find a convenient, cost-effective and noninvasive method to reduce the false-positive rate of breast ultrasound. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS in breast ultrasound-positive patients. Patients and methods: 134 subjects ( malignant group, n=96; 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™-SS were evaluated respectively. Results: The sensitivity of YiDiXie™-SS in the malignant group was 97.9%(95% CI: 92.7% - 99.6%; 94/96) with a false negative rate of 2.1%(95% CI: 0.4% - 7.3%;2/96). The specificity of YiDiXie™-SS for the benign group was 63.2%(95% CI: 47.3% - 76.6%; 24/38), and the false positive rate was 36.8%(95% CI: 23.4% - 52.7%; 14/38) . This means that YiDiXie™-SS reduces the false positive rate by 63.2%(95% CI: 47.3% - 76.6%; 24/38) with essentially no increase in malignancy leakage. Conclusion: YiDiXie™-SS significantly reduces the false-positive rate of breast ultrasound-positive patients without increasing the number of under-diagnosed malignant tumors. YiDiXie™-SS has vital diagnostic value in breast ultrasound-positive patients, and is expected to solve the problem of "high false-positive rate of breast ultrasound". Clinical trial number: ChiCTR2200066840. Key words: Breast cancer, Ultrasound Scan, False-positive, YiDiXie™-SS