Evaluation of the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in brain malignant tumors
Authors: Wu Yutong , Sun Chen , Ge Zhenjian , Zhou Huimei , Li Xutai , Chen Wenkang , Li Yingqi , Lin Shengjie , Zhang Pengwu , Wang Wuping , Chen Siwei , Li Wei , Hu Jun , Ji Ling , Lai Yongqing 
Published: August 2024

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 lead to misdiagnosis and incorrect surgery or treatment, while false-negative results of enhanced MRI will lead to underdiagnosis of malignant tumors and delayed treatment. There is an urgent need to find convenient, cost-effective and non-invasive diagnostic methods to reduce the false-positive and false-negative 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

233 subjects (malignant group, n=74; benign group, n=159) 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 was 97.3% (95% CI: 90.7% - 99.5%) and its specificity was 63.5% (95% CI: 55.8% - 70.6%). This means that YiDiXie ™ -SS has a very high sensitivity and specificity in brain tumors.YiDiXie ™ -HS has a sensitivity of 83.8% (95% CI: 73.8% - 90.5%) and a specificity of 84.9% (95% CI: 78.5% - 89.6%). This means that YiDiXie™-HS has high sensitivity and specificity in brain tumors.YiDiXie™-D has a sensitivity of 70.3% (95% CI: 59.1% - 79.5%) and a specificity of 93.7% (95% CI: 88.8% - 96.5%). This means that YiDiXie™-D has high sensitivity and very high specificity in brain tumors. The sensitivity of YiDiXie™ SS in patients with positive enhancement MRI was 98.3% (95% CI: 91.1% - 99.9%) and its specificity was 62.5% (95% CI: 38.6% - 81.5%). This means that the application of YiDiXie ™ -SS reduces the false-positive rate of enhanced MRI by 62.5% (95% CI: 38.6% - 81.5%) with essentially no increase in the leakage of malignant tumors.The sensitivity of YiDiXie™-HS in patients with negative enhanced MRI was 85.7% (95% CI: 60.1% - 97.5%) and its specificity was 84.6% (95% CI: 77.8% - 89.6%). This means that the application of YiDiXie ™ -HS reduced the false-negative rate of enhanced MRI by 85.7% (95% CI: 60.1% - 97.5%). YiDiXie™-D had a sensitivity of 71.7% (95% CI: 59.2% - 81.5%) and a specificity of 93.8% (95% CI: 71.7% - 99.7%) in patients with positive enhanced MRI. This means that YiDiXie™ -D reduced the false-positive brain enhanced MRI rate by 93.8% (95% CI: 71.7% - 99.7%). YiDiXie™-D had a sensitivity of 64.3% (95% CI: 38.8% - 83.7%) and a specificity of 93.7% (95% CI: 88.5% - 96.7%) in patients with negative enhanced MRI. This means that YiDiXie ™ -D reduces the false-negative rate of enhanced MRI by 64.3% (95% CI: 38.8% - 83.7%) while maintaining high specificity.

Conclusion

YiDiXie ™ -SS has extremely high sensitivity and high specificity in brain tumors.YiDiXie ™ -HS has high sensitivity and high specificity in brain tumors.YiDiXie ™-D has high sensitivity and extremely high specificity in brain tumors.YiDiXie™-SS significantly reduces the false-positive rate of brain-enhanced MRIs with essentially no increase in delayed treatment of malignant tumors. The YiDiXie™-HS significantly reduces the false-negative rate of brain-enhanced MRI. the YiDiXie™-D can significantly reduce the false-positive rate of brain-enhanced MRI or significantly reduce the false-negative rate of brain-enhanced MRI while maintaining a high level of specificity. The YiDiXie™ test has significant diagnostic value in brain tumors, and is expected to solve the problems of “ high false-positive rate “ and “ high false-negative rate” of brain-enhanced MRI.

Clinical trial number

ChiCTR2200066840.