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 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.

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.

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. Competing Interest Statement The authors have declared no competing interest. Clinical Trial ChiCTR2200066840 Funding Statement This work was supported by Shenzhen High-level Hospital Construction Fund, Clinical Research Project of Peking University Shenzhen Hospital (LCYJ2020002, LCYJ2020015, LCYJ2020020, LCYJ2017001). Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee of Peking University Shenzhen Hospital gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes The results were updated. Tabel 2-8 were reviesed. Data Availability All data produced in the present study are contained in the manuscript.