Evaluation of the diagnostic value of YiDiXie™-SS and YiDiXie™ -HS in uroepithelial carcinoma

Uroepithelial carcinoma is a serious threat to human health and causes heavy economic burden. Enhanced CT is widely used in screening or preliminary diagnosis of uroepithelial tumors. However, false-positive results of enhanced CT will bring unnecessary mental pain, expensive examination costs, physical injuries, and other adverse consequences; 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-negative and false-positive rates of enhanced CT in uroepithelial tumors. The aim of this study was to evaluate the diagnostic value of YiDiXie™-SS and YiDiXie™-HS in uroepithelial carcinoma.

Patients and methods

319 subjects (malignant group, n=240; benign group, n=79) 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 and YiDiXie™-HS.

Results

The sensitivity of YiDiXie™-SS in enhanced CT-positive patients was 96.3% (95% CI: 96.3% - 98.3%; 158/164)and its specificity was 64.3% (95% CI: 38.8% - 83.7%; 9/14). This means that the application of YiDiXie ™ -SS reduces the false-positive rate of urological enhanced CT by 64.3% (95% CI: 38.8% - 83.7%; 9/14) with essentially no increase in malignancy leakage. The sensitivity of YiDiXie™-HS in enhanced CT-negative patients was 85.5% (95% CI: 75.9% - 91.7%; 65/76)and its specificity was 84.6% (95% CI: 73.9% - 91.4%; 55/65). This means that the application of YiDiXie™-HS reduces the false-negative rate of urological enhanced CT by 85.5% (95% CI: 75.9% - 91.7%; 65/76).

Conclusion

YiDiXie ™ -SS substantially reduces the rate of urological enhanced CT false positives with essentially no increase in delayed treatment of malignancies. YiDiXie™-HS substantially reduces the false negative rate of urological enhanced CT. YiDiXie™ -SS and YiDiXie™ -HS have an important diagnostic value in uroepithelial carcinoma, and are expected to solve the problems of “high false-positive rate of urological enhanced CT” and “high false-negative rate of urological enhanced CT” in uroepithelial carcinoma.

Clinical trial number

ChiCTR2200066840.