Abstract
OBJECTIVES: To evaluate the diagnostic performance of FDA-approved urinary biomarkers in the evaluation of primary haematuria for investigation of bladder cancer. METHODS: The scientific databases MEDLINE, EMBASE, Pubmed and Web of Science were searched to collect studies. Studies that evaluated the diagnostic performance of FDA-approved urinary biomarkers in investigating patients with primary haematuria without a prior history of bladder cancer were included. Quality of studies was assessed using the JBI Criteria. Bivariate mixed-effects regression model was used to calculate pooled sensitivities and specificities for each biomarker. RESULTS: Eighteen studies were included in the analysis. The biomarkers assessed in these studies were CxBladder, AssureMDx, Bladder Tumour Antigen (BTA), NMP22, UroVysion and Immunocyt/uCyt+. Several biomarkers, such as AssureMDx, CxBladder and Immunocyt, were shown to have better diagnostic performance based on their sensitivity, specificity and diagnostic odds ratio, as well as positive and negative likelihood ratios. Across the six biomarkers, sensitivity ranged from 0.659 to 0.973, and the specificity ranged between 0.577 and 0.833. CONCLUSION: Despite certain biomarkers demonstrated better performance, current diagnostic abilities of the FDA-approved biomarkers remain insufficient for their general application as a rule out test for bladder cancer diagnosis and as a triage test for cystoscopy in patients with primary haematuria. High-quality prospective studies are required to further analyse this and also analyse the correct scenario in which urinary biomarkers may be best utilised.