Use of immunocytology to predict bladder cancer presence in patients with asymptomatic hematuria.
242 Background: The uCyt immunocytology assay detects cellular biomarkers for bladder cancer (BCa) in exfoliated urothelial cells. We assessed the performance of uCy for detecting BCa in patients undergoing initial evaluation for asymptomatic hematuria. Methods: Data from 1,182 subjects without a history of BCa undergoing evaluation for hematuria were collected at three centers: EuromedClinic/Urologie24, University of Tübingen, and Central Hospital of Bolzano. All subjects underwent standard workup (i.e., voided cytology, upper tract imaging, and cystoscopy) and immunocytology. Results: Overall, 245 subjects had BCa (20.7%). The sensitivity/specificity/negative predictive value for uCyt and cytology were 82.4%/86.6%/95.0% and 46.5%/94.9%/87.2%, respectively. uCyt (OR 18.3, p<0.001) and cytology (OR 2.9, p<0.001) were associated with BCa in a multivariable analysis. The base model (age, gender, smoking status, type of hematuria) predicted BCa with an accuracy of 74.1%. Addition of cytology to the base model improved predictive accuracy (PA) to 83.5% (p<0.001), while addition of uCyt to the base model improved PA to 90.1% (p<0.001). Addition of uCyt to Model 1 significantly improved PA (+7.6%, p<0.001), but addition of cytology to Model 2 did not (+1.0%, p=0.057). uCyt performed equally well in patients with microscopic and gross hematuria (OR 30 vs. 27), while cytology did not (OR 18 vs. 12). Conclusions: uCyt is a strong, independent predictor of BCa in patients with hematuria; it outperforms cytology. uCyt may help with patient counseling, quality of care optimization (referral prioritization), and possibly sparing unnecessary hematuria workup in patients at extremely low risk of BCa. [Table: see text] No significant financial relationships to disclose.