Evaluation of the diagnostic performance of YiDiXie™ tests in urothelial carcinoma

Computed tomography (CT) is widely used to the diagnosis of upper urinary tract epithelial tumors, but the relatively inaccurate results may affect subsequent treatment. Cystoscopy is widely used for preoperative diagnosis of bladder tumors and postoperative review of urothelial carcinoma, but its invasiveness and corresponding complications are feared by patients. There is an urgent need to find a convenient, cost-effective and non-invasive diagnostic method to reduce the false-positive and false-negative rates of urinary tract CT, and to replace cystoscopy in the preoperative diagnosis of bladder tumors or postoperative monitoring the bladder for recurrent of urothelial carcinoma. The study aimed to evaluate the diagnostic value of YiDiXie™-30, YiDiXie™-32, and YiDiXie™-48 in urothelial cancer.

439 study subjects were finally included in this study (malignant group, n = 292, benign group, n = 90; relapse group, n = 22, relapse-free group, n = 35). The remaining serum samples from the subjects were collected and tested by applying the YiDiXie™ all-cancer detection kit to evaluate the sensitivity and specificity, positive likelihood ratio, and negative likelihood ratio of YiDiXie™-30, YiDiXie™-32, and YiDiXie™-48. Receiver-operating characteristic curves' analyses were included in this study.

The sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of YiDiXie™-30 were 74.7%, 92.2%, 9.6, and 0.27, respectively. The sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of YiDiXie™-32 were 86.6%, 84.4%, 5.6, and 0.16, respectively. The sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio were 96.2%, 65.6%, 2.8, and 0.06, respectively. Further studies revealed that YiDiXie™-30, YiDiXie™-32, and YiDiXie™-48 had similar results in patients with positive or negative urothelial CT. The negative likelihood ratios of YiDiXie™-30, YiDiXie™-32, and YiDiXie™-48 with ultrasound concurrently in the relapse and relapse-free groups were 0.05, 0.05, and 0. In the malignant and benign groups with diameters < 2.0 cm negative likelihood ratios of YiDiXie™-30.

YiDiXie™ tests showed considerable validity in the diagnosis of urothelial carcinoma with significantly different levels of sensitivity and specificity. They have significant diagnostic value in urothelial carcinoma, improving the diagnosis of upper urinary tract epithelial tumors and potentially providing an alternative to cystoscopy in combination with CT or ultrasound. Clinical study registration number ChiCTR2200066840.