Utility of urinary biomarkers in primary haematuria: Systematic review and meta‐analysis

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.

Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients

“…13,14 In a meta-analysis of 6 urinary biomarkers, including Cxbladder, the sensitivities and specificities ranged from 0.66 to 0.97 and 0.58 to 0.83, respectively. 15 While no published study has performed a head to head comparison between these urinary biomarkers, the observed cost savings in the current study illuminates Cxbladder Detect potential as a promising tool in the diagnostic pathway for microhematuria patients.…”

TERT promoter mutations and methylation for telomerase activation in urothelial carcinomas: New mechanistic insights and clinical significance

“…UC patients typically present with hematuria, however, hematuria is not specific to UCs and can occur in up to 9–18% of the population ( 95 ). Therefore, distinguishing between UC- and other genitourinary disorder-causing hematuria is an essential aim in the patient management.…”

Shining a little light on peer review debates

“…For our review article this issue, Soputro et al 4 review the diagnostic performance of regulatory approved urinary biomarkers for investigating primary haematuria for bladder cancer. Of 18 studies of six biomarkers analysed, the sensitivities ranged from 0.659 to 0.973 and specificities from 0.577 to 0.833.…”