Abstract

There is a need for sensitive and specific biomarkers for detecting recurrences in patients with non-muscle invasive bladder cancer (NMIBC) on surveillance. Xpert bladder cancer (BC) monitor is the latest rapid in vitro qualitative test that detects expression of 5 mRNAs using a GeneXpert instrument. The primary aim of this review was to systematically review and pool the data regarding the diagnostic performance of Xpert BC in patients with NMIBC. Systematic literature search using 4 electronic databases (PubMed, EMbase, Scopus and Web of science) was performed. Pooled sensitivity, specificity and diagnostic odds ratio (DOR) were estimated using DerSimonian-Laird random-effects model. Standard Preferred Reporting Items for Systematic reviews and Meta-analysis guidelines were followed and the study protocol was registered with PROSPERO (CRD42021249762). In this review, 11 prospective studies with 2,896 patients were included. Pooled sensitivity and specificity for Xpert BC were 73% (95% confidence interval (CI) 65%-80%) and 77% (95% CI 69%-84%) respectively. Area under curve (AUC) for Xpert BC monitor was 0.81 (0.78-0.84) respectively. Subgroup analysis from 7 studies for patients with high-grade recurrence revealed sensitivity, specificity and AUC of 0.86 (0.77-0.92), 0.78 (0.75-0.81) and 0.87 (0.84-0.90) respectively. Similar analysis for patients with low-grade recurrence revealed sensitivity, specificity and AUC of 0.58 (0.47-0.68), 0.79 (0.75-0.82) and 0.79 (0.75-0.82) respectively. Xpert BC monitor has overall acceptable diagnostic accuracy. Sensitivity is higher for high-grade disease for detecting recurrences in patients with NMIBC on surveillance.

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