The performance of the Xpert Bladder Cancer Monitor Test and voided urinary cytology in the follow-up of urinary bladder tumors

Abstract

BackgroundCystoscopy in complement with urinary cytology represents the gold standard for the follow-up of patients with urinary bladder tumours. Xpert Bladder Cancer Monitor Test (XBC) is a novel mRNA-based urine test for bladder cancer surveillance. The aim of the study was to evaluate the performance of the XBC and voided urinary cytology (VUC) in the follow-up of bladder tumours.Patients and methodsThe XBC was performed on stabilized voided urine and VUC was performed on urine samples. The results were compared to cystoscopic findings and histopathological results after transurethral resection of the bladder lesion.ResultsFor the prediction of malignant histopathological result sensitivity, the specificity and negative predictive value were 76.9%, 9 7.5% and 93.0% for the XBC and 38.4%, 9 7.5% and 83.3%, respectively for VUC. For the prediction of suspicious or positive cystoscopic finding sensitivity, the specificity and negative predictive value were 75.0%, 95.2%, and 93.0% respectively for the XBC and 41.7%, 97.6%, and 85.4% for VUC. The sensitivities for papilary urothelial neoplasms of low malignant potential (PUNLMP), low- and high-grade tumours were 0.0%, 66.7% an d 100.0% for the XBC and 0.0%, 66 .7% and 42.9%, respectively for VUC.ConclusionsThe XBC showed significantly higher overall sensitivity and negative predictive value than VUC and could be used to increase the recommended follow-up cystoscopy time intervals. Complementing the XBC and voided urinary cytology does not improve performance in comparison to the XBC alone.

Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non–muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis

“…Twenty-one studies, comprising 7330 patients, were included in the quantitative synthesis. All the studies included in the quantitative synthesis reported on the diagnostic value of UBTs for the detection of recurrence during surveillance: ten studies on Xpert bladder cancer [17][18][19][20][21][22][23][24][25][26], five studies on Bladder EpiCheck [26][27][28][29][30], three on Adxbladder [31][32][33], two on Uromonitor [34,35], and two on Cxbladder Monitor [36,37].…”

“…Ten studies provided data on the diagnostic values of the Xpert bladder cancer UBT for the diagnosis of recurrence during NMIBC follow-up [17][18][19][20][21][22][23][24][25][26]. The pooled Se, Sp, PPV, and NPV were 0.72 (95% CI 0.63-0.80), 0.76 (95% CI 0.72-0.81), 0.43 (95% CI 0.32-0.54), and 0.92 (95% CI 0.90-0.94), respectively (Fig.…”

Clinical Evaluation of Two Non-Invasive Genetic Tests for Detection and Monitoring of Urothelial Carcinoma: Validation of UroVysion and Xpert Bladder Cancer Detection Test

“…A negative result is achieved if the LDA total is below the cut-off point and the ABL1 Ct is within the valid range. The manufacturer determined the cut-off point of the LDA total at 0.4450 on the basis of statistical analysis of a large number of samples ( Wallace et al, 2018 ; F. Johannes P.; van Valenberg et al, 2019 ; Pichler et al, 2018 ; Smrkolj et al, 2020 ). The result is ‘invalid’ if the presence or absence of target mRNAs cannot be determined, if the ABL1 Ct and/or CIC Ct do not meet the criteria, and if the cell content in the urine sample is too low or the PCR reaction was inhibited.…”

RNA-based urinary assays for non-muscle invasive bladder cancer

“…Ten studies evaluated the test metrics of an RNAbased urine assay in patients under surveillance for NMIBC [20,[25][26][27][28][29][30][31][32][33]]. An overview of articles is shown in Table 3.…”

“…An overview of articles is shown in Table 3. Eight studies assessed test performance of the Xpert Bladder Cancer Monitor (XBCM), evaluating 2257 patients in total [25,[27][28][29][30][31][32][33]. The XBCM test measures the same mRNA targets as the XBCD but uses a different algorithm and cut-off to make the tests suitable for the surveillance setting [18 & ,23].…”