Xpert Bladder Cancer (BC) is an mRNA-based urine assay for diagnosis and surveillance of urothelial carcinoma. Although previous meta-analyses have examined Xpert, none has evaluated its accuracy in both BC detection and non-muscle-invasive bladder cancer (NMIBC) surveillance, while also exploring its potential role in guiding repeat transurethral resection (re-TURBT) and in the diagnostic evaluation of upper tract urothelial carcinoma (UTUC). We systematically assessed the diagnostic accuracy of Xpert in all these clinical settings, integrating grade-specific analysis and formal evidence-certainty assessment. PubMed/MEDLINE, Embase, Scopus, Web of Science, and the Cochrane Library were searched to January 2026 (PROSPERO: CRD420251184275). Sensitivity and specificity were pooled using bivariate random-effects models; PPV and NPV using univariate models. Grade-specific sensitivity was pooled across 13 studies with tumour-grade-stratified data. Evidence certainty was assessed using GRADE-DTA. Publication bias was evaluated with Deeks' funnel plots. Twenty-six studies (8613 patients) were included. For Detection (k = 8, where k denotes the number of cohorts pooled), pooled sensitivity was 0.83 (95% CI 0.73-0.90) and specificity 0.77 (0.65-0.86); NPV was 0.96. For Monitor (k = 15), sensitivity was 0.71 (0.63-0.77) and specificity 0.78 (0.70-0.85); NPV was 0.91. Grade-specific pooling showed high-grade (HG) sensitivity of 0.89 (0.83-0.93) in Detection and 0.80 (0.71-0.87) in Monitor, versus 0.60 for low-grade (LG) in both settings; heterogeneity was not statistically significant for HG estimates. Re-TURBT (k = 2) and UTUC (k = 2) were exploratory, with encouraging NPV but limited by sparse events. Evidence certainty was low for sensitivity/NPV and very low for specificity/PPV. No publication bias was detected. Xpert demonstrates high sensitivity and NPV, particularly for HG disease, supporting its role as an adjunctive rule-out tool. Grade-adapted interpretation is warranted. Prospective validation with standardised grade-specific reporting is needed.
Scientific reports. 2026 Jun 14 [Epub ahead of print]
Ludovica Cella, Vittorio Fasulo, Alessandro Uleri, Andrea Piccolini, Valerio Mallia, Francesco Sormani, Alessio Finocchiaro, Roberto Contieri, Stefano Moretto, Pier Paolo Avolio, Alberto Saita, Rodolfo Hurle, Paolo Casale, Giovanni Lughezzani, Nicolò Maria Buffi, Massimo Lazzeri, Marco Paciotti
Department of Biochemical Science, Humanitas University, Milan, Italy., Department of Urology, North Academic Hospital, AP-HM, Marseille, France., Urology Department, Istituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Naples, Italy., Department of Urology, Humanitas Clinical and Research Institute IRCCS, Milan, Italy., Department of Urology, Humanitas Clinical and Research Institute IRCCS, Milan, Italy. .