Diagnostic accuracy of Bladder EpiCheck for upper tract urothelial carcinoma: A meta-analysis.

Abstract

Introduction and objective: Current upper tract urothelial carcinoma(UTUC) diagnosis and disease management rely on the combination of CT Urography(CTU), cytology and ureteroscopy(URS). The limited accuracy and complications associated with these tools have led to the search for non-invasive and reliable biomarkers. Our aim was to review and analyse the existing data on the use of Bladder EpiCheck® to assess its performance as a diagnostic tool for UTUC.

Material and methods: A literature search on the diagnostic value of Bladder EpiCheck® as a urinary biomarker in UTUC was conducted through PubMed, Web of Science and Scopus until February 2024. Pooled sensitivity(Se), specificity(Sp), negative predictive value(NPV) and positive predictive value(PPV) of the biomarker were calculated. Diagnostic performance was assessed through the area under the curve(AUC).

Results: Four studies, including 334 patients, were included in the quantitative analysis. Bladder EpiCheck® showed promising pooled diagnostic values with Se of 0.85(95%CI 0.55-0.96), Sp of 0.93(95%CI 0.56-0.99), PPV of 0.74(95%CI 0.54-0.87) and NPV of 0.84(95%CI 0.77-0.89). The exact AUC obtained was 0.912.

Conclusions: Bladder EpiCheck® is an effective diagnostic tool in UTUC, showing a promising diagnostic accuracy, with a Se and NPV of 85% and 84%, respectively. Its use in UTUC diagnosis and follow-up could reduce or postpone the need for more invasive procedures, such as URS, thereby reducing the procedure-associated risks and improving patients' quality of life. Although further research and large prospective studies are needed, the current results indicate that Bladder EpiCheck® is a promising tool in UTUC diagnosis, treatment decision-making, and follow-up.