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

Renal cancer is a serious threat to human health and causes heavy economic burden. Enhanced CT is widely used in the diagnosis of renal tumors. However, false-positive results of 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 and false-negative 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 cancer.

Patients and methods

309 subjects (malignant group, n=244; 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

YiDiXie™-SS had a sensitivity of 98.6% (95% CI: 95.8% – 99.6%; 204/207) and a specificity of 71.4% (95% CI: 45.4% – 88.3%; 10/14) in renal enhanced CT-positive patients. This means that the application of YiDiXie ™ –SS reduces the false-positive rate of renal enhanced CT by 71.4% (95% CI: 45.4% – 88.3%; 10/14) with essentially no increase in malignant tumor leakage. The sensitivity of YiDiXie™-HS in renal enhanced CT-negative patients was 86.5% ( 95% CI: 72.0% – 94.1%; 32/37) and its specificity was 84.3% (95% CI: 72.0% – 91.8%; 43/51). This means that the application of YiDiXie™-HS reduces the false-negative rate of enhanced CT by 86.5% (95% CI: 72.0% – 94.1%; 32/37). The sensitivity of YiDiXie ™-D in renal enhanced CT-positive patients was 31.9% (95% CI: 25.9% – 38.5%; 66/207) and its specificity was 92.9% (95% CI: 68.5% – 99.6%; 13/14). This means that YiDiXie™-SS 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 renal enhanced CT with essentially no increase in delayed treatment of malignant tumors. YiDiXie™-HS dramatically reduces the false-negative rate of renal enhanced CT. YiDiXie ™ –D dramatically reduces the false-positive rate of renal enhanced CT. The YiDiXie ™ test has significant diagnostic value in renal tumors, and is expected to solve the problems of “high false-positive rate of renal enhanced CT” and “high false-negative rate of renal enhanced CT”.

Clinical trial number

ChiCTR2200066840.