Description:
<jats:sec><jats:title>Objectives</jats:title><jats:p>To evaluate the diagnostic accuracy of the Xpert Bladder Cancer (<jats:styled-content style="fixed-case">BC</jats:styled-content>) Monitor, compared with cystoscopy and cytology in the oncological follow‐up of non‐muscle‐invasive bladder cancer (<jats:styled-content style="fixed-case">NMIBC</jats:styled-content>).</jats:p></jats:sec><jats:sec><jats:title>Material and Methods</jats:title><jats:p>A total of 140 patients with a history of <jats:styled-content style="fixed-case">NMIBC</jats:styled-content> undergoing routine surveillance at our institution were enrolled prospectively in this study (<jats:styled-content style="fixed-case">ISRCTN</jats:styled-content> study registry number 37210907). Urine cytology was evaluated according to the Paris classification system. In addition, urinary specimens were analysed using the Xpert <jats:styled-content style="fixed-case">BC</jats:styled-content> Monitor, which measures five target <jats:styled-content style="fixed-case">mRNA</jats:styled-content>s (<jats:styled-content style="fixed-case">ABL</jats:styled-content>1, <jats:styled-content style="fixed-case">CRH</jats:styled-content>,<jats:styled-content style="fixed-case"> IGF</jats:styled-content>2, <jats:styled-content style="fixed-case">UPK</jats:styled-content>1B, <jats:styled-content style="fixed-case">ANXA</jats:styled-content>10) using real‐time <jats:styled-content style="fixed-case">PCR</jats:styled-content>. Descriptive analysis, diagnostic accuracy including sensitivity, specificity, positive (<jats:styled-content style="fixed-case">PPV</jats:styled-content>) and negative predictive value (<jats:styled-content style="fixed-case">NPV</jats:styled-content>), receiver‐operating characteristic curve, and area under the curve (<jats:styled-content style="fixed-case">AUC</jats:styled-content>) were calculated.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The overall sensitivity (0.84) and <jats:styled-content style="fixed-case">NPV</jats:styled-content> (0.93) of the Xpert <jats:styled-content style="fixed-case">BC</jats:styled-content> Monitor were significantly superior to those of bladder washing cytology (0.33 and 0.76; <jats:italic>P</jats:italic> < 0.001). Subgroup analyses confirmed the high sensitivity of the Xpert <jats:styled-content style="fixed-case">BC</jats:styled-content> Monitor even in low‐grade (0.77) and <jats:styled-content style="fixed-case">pT</jats:styled-content>a (0.82) disease compared with barbotage cytology (low‐grade: 0.13; <jats:styled-content style="fixed-case">pT</jats:styled-content>a: 0.21). The overall specificity of the Xpert <jats:styled-content style="fixed-case">BC</jats:styled-content> Monitor and barbotage cytology was similar (0.91 vs 0.94; <jats:italic>P</jats:italic> = 0.41). Combining the Xpert <jats:styled-content style="fixed-case">BC</jats:styled-content> Monitor with barbotage cytology (<jats:styled-content style="fixed-case">AUC</jats:styled-content> = 0.85) did not enhance diagnostic performance compared with the performance of the Xpert <jats:styled-content style="fixed-case">BC</jats:styled-content> Monitor alone (<jats:styled-content style="fixed-case">AUC</jats:styled-content> = 0.87).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>In this study, we report for the first time that the Xpert <jats:styled-content style="fixed-case">BC</jats:styled-content> Monitor, a new <jats:styled-content style="fixed-case">mRNA</jats:styled-content>‐based urine test, outperforms cytology with regard to sensitivity and <jats:styled-content style="fixed-case">NPV</jats:styled-content>, even in low‐grade and <jats:styled-content style="fixed-case">pT</jats:styled-content>a tumours, with no reduction of specificity.</jats:p></jats:sec>