Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in brain malignant tumors

Background: Brain malignant tumors is a serious threat to human health and causes heavy economic burden. Enhanced MRI is widely used in the diagnosis of brain tumors. However, false-positive results of enhanced MRI will bring unnecessary mental pain, expensive examination costs, physical injuries, and other adverse consequences; while false-negative results of enhanced MRI bring delayed treatment, and patients will thus have to bear the adverse consequences of poor prognosis, high treatment costs, poor quality of life, and short survival period. There is an urgent need to find convenient, cost-effective and non-invasive diagnostic methods to reduce the false-negative and false-positive rates of brain-enhanced MRI. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in brain malignant tumors. Patients and methods: 235 subjects (malignant group, n=75; benign group, n=160) were finally included in this study. Remaining serum samples from the subjects were collected and tested by applying the YiDiXie™ all-cancer detection kit to evaluate the sensitivity and specificity of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D. Results: The sensitivity of YiDiXie™-SS in enhanced MRI-positive patients was 98.4% (95% CI: 91.3% - 99.9%; 60/61) and its specificity was 62.5% (95% CI: 38.6% - 81.5%; 10/16). This means that the application of YiDiXie™-SS reduces the false-positive rate of brain enhanced MRI by 62.5% (95% CI: 38.6% - 81.5%; 10/16) with essentially no increase in malignancy leakage. The sensitivity of YiDiXie™-HS in enhanced MRI-negative patients was 85.7% (95% CI: 60.1% - 97.5%; 12/14) and its specificity was 84.7% (95% CI: 78.0% - 89.7%; 122/144). This means that the application of YiDiXie™-HS reduces the false-negative rate of brain-enhanced MRI by 85.7% (95% CI: 60.1% - 97.5%; 12/14). The sensitivity of YiDiXie™-D in enhanced MRI-positive patients was 34.4% (95% CI: 23.7% - 47.0%; 21/61) and its specificity was 93.8% (95% CI: 71.7% - 99.7%; 15/16). This means that the application of YiDiXie™-HS reduces the false-positive rate of brain-enhanced MRI by 93.8% (95% CI: 71.7% - 99.7%; 15/16). Conclusion: YiDiXie™-SS significantly reduces the false-positive rate of brain-enhanced MRI without increasing the delay in treatment of malignant tumors. YiDiXie™-HS dramatically reduces the false-negative rate of brain-enhanced MRI. YiDiXie™-D dramatically reduces the false-positive rate of brain-enhanced MRI. The YiDiXie™ test has significant diagnostic value in brain tumors, and is expected to solve the problems of "high false-negative rate of enhancement MRI" and "high false-positive rate of enhancement MRI" in brain tumors. Clinical Research Registration Number:ChiCTR2200066840. Keywords: Brain tumor, Enhanced MRI, False-positive, False-negative, YiDiXie™-SS, YiDiXie™-HS, YiDiXie™-D