BACKGROUND: Renal cancer is a serious threat to human health and causes heavy economic burden. Ultrasound is widely used in screening or preliminary diagnosis of renal tumors, and enhanced CT is widely used in the diagnosis of renal tumors. However, false-positive results of ultrasound and enhanced CT will bring unnecessary mental pain, expensive examination costs, physical injuries, and even adverse consequences such as organ removal and loss of function; while false-negative results of enhanced CT 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-positive rate of ultrasound and the false-negative and false-positive rates of enhanced CT in renal tumors. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS, YiDiXie™-HS and YiDiXie™-D in renal tumors. MATERIALS AND METHODS: 298 subjects (malignant group, n=233; benign group, n=65) 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, respectively. RESULTS: The sensitivity of YiDiXie™-SS in renal ultrasound-positive patients was 98.3% (95% CI: 95.7% - 99.3%; 229/233) with a specificity of 66.2% (95% CI: 54.0% - 76.5%; 43/65). Compared to the application of enhanced CT alone, sequential use of YiDiXie™-SS and CT had comparable sensitivity, but the false positive rate decreased from 21.5% (95% CI: 13.3% - 33.0%; 14/65) to 6.2% (95% CI: 2.4% - 14.8%; 4/65). This means that the application of YiDiXie™-SS reduced the false-positive rate of ultrasound by 66.2% (95% CI: 54.0% - 76.5%; 43/65) and the false-positive rate of enhanced CT by 71.4% with essentially no increase in malignancy leakage.The sensitivity of YiDiXie™-HS in patients with a negative enhanced CT was 86.1% (95% CI. 71.3% - 93.9%; 31/36) and specificity was 84.3% (95% CI: 72.0% - 91.8%; 43/51). This means that YiDiXie™-HS reduced the false-negative rate of enhanced CT by 86.1% (95% CI: 71.3% - 93.9%; 31/36).YiDiXie™-D had a sensitivity of 29.4% (95% CI: 23.5% - 36.2%; 58/197) and a specificity of 92.9% (95% CI: 68.5% - 99.6%) in patients with positive enhanced CT. This means that YiDiXie™-D reduces the false positive rate of enhanced CT by 92.9% (95% CI: 68.5% - 99.6%; 13/14). CONCLUSION: YiDiXie™-SS dramatically reduces the false-positive rate of ultrasound and enhanced CT with essentially no increase in delayed treatment of malignant tumors. YiDiXie™-HS dramatically reduces the false-negative rate of enhanced CT. YiDiXie™-D dramatically reduces the false-positive rate of enhanced CT. The YiDiXie™ test has significant diagnostic value in renal tumors, and is expected to solve the 3 problems of "high false-positive rate of ultrasound", "high false-negative rate of enhanced CT" and "high false-positive rate of enhanced CT". Clinical Research Registration Number:ChiCTR2200066840. Keywords:Renal cancer, Ultrasound, Enhanced CT, False-positive, False-negative, YiDiXie™-SS, YiDiXie™-HS, YiDiXie™-D

The authors have declared no competing interest.

ChiCTR2200066840

This work was supported by Shenzhen High-level Hospital Construction Fund, Clinical Research Project of Peking University Shenzhen Hospital (LCYJ2020002, LCYJ2020015, LCYJ2020020, LCYJ2017001).

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Ethics committee of Peking University Shenzhen Hospital gave ethical approval for this work.

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