Table 1.

Available commercial kits performance and characteristics.

Name (Commercially Available Kits/Procedures)	FDA Approval/CE Mark	Present in EAU Guidelines 2019	Sample	Starting Material	Technology	Type of biomarker assessed	Purpose	Overall Performance	References
Cytology	Yes	Yes	Urine	Exfoliated cells	Giemsa an H&E staining	Cell phenotype	Diagnostic & Surveillance	Sensitivity = 38% Specificity = 98%	Christopher G.T. Blick, et al. 2011 [41]
uCyt+	Yes/NA*1	No	Urine	Exfoliated cells	Immunofluorescence	Antigens/ Metabolites	Surveillance	Sensitivity = 73% Specificity = 66%	He, H. et al. 2016 [57]
NMP22	Yes/Yes	Yes	Urine	Exfoliated cells	Elisa	Peptides	Surveillance	Sensitivity = 40% Specificity = 99%	Mowatt, G. et al. 2010 [58]
CellSearch	Yes/Yes	No	Plasma/serum	CTC’s	Immunomagnetic enrichment	Proteins	Surveillance	Sensitivity = 35% Specificity = 97%	Zhang, Z. et al. 2017 [59]
UroVysion	Yes/Yes	Yes	Urine	Exfoliated cells	FISH	DNA (Aneuploidies)	Diagnostic	Sensitivity= 72% Specificity = 83%	Hajdinjak, T. et al. 2008 [60]
BTA stat/ BTA Track	Yes/NA*1	No	Urine	Exfoliated cells	Dipstick immunoassay	Proteins	Diagnostic & Surveillance	Sensitivity = 70% Specificity = 75%	Glas, A.S. et al. 2003 [61]
CxBladder	No/No	No	Urine	Exfoliated cells	RT-qPCR	RNA (messenger RNA)	Diagnostic	Sensitivity = 82% Specificity = 85%	O’Sullivan, P. et al. 2012 [62]
Xpert Detection	No/Yes	No	Urine	Exfoliated cells	RT-qPCR	RNA (messenger RNA)	Diagnostic	Sensitivity = 76% Specificity = 85%	Valenberg FJP, V. et al. 2017 [63]
Uromonitor	No/Yes	Yes*2	Urine	Exfoliated cells	Real-time PCR	DNA (tumor cell DNA)	Surveillance	Sensitivity = 74% Specificity = 93%	Batista, R. et al. 2019 [56]
Epicheck	No/Yes	No	Urine	Exfoliated cells	Real-time PCR	DNA (methylation)	Surveillance	Sensitivity = 68% Specificity = 88%	Witjes, A. et al. 2018 [64]
UroSEEK	No/No	No	Urine	Exfoliated cells	Massively parallel sequencing-based assay	DNA (tumor cell DNA)	Diagnostic & Surveillance	Sensitivity = 95% Specificity = 93%	Springer, S.U. et al. 2018 [65]

*1 Information not available; *2 EAU guidelines refer the use of TERT/FGFR3 testing that composes Uromonitor test.