. 2018 Dec 14;10:251–261. doi: 10.2147/RRU.S173027

Table 1.

Urine-based tests to diagnosis and post-TURBT monitoring for bladder cancer (BCa)

Name of assay	Biomaterial	Marker description	Assay	Application purpose	Diagnostic accuracy (%)		Approval		Reference
Name of assay	Biomaterial	Marker description	Assay	Application purpose	Sensitivity	Specificity	FDA	Japanese health insurance
Urine cytology	Sediment	Morphology	Staining and microscopical exam	Diagnosis	38	98	Yes	Yes	31
Urine cytology	Sediment	Morphology	Staining and microscopical exam	Monitoring	16–53	94–100	Yes	Yes	32, 33
ImmunoCyt/uCyt+	Sediment	Tumor-associated cellular antigens (M344, LDQ10, 19A11)	Immunofluorescence	Monitoring	73	66	Yes	No	35
UroVysion	Sediment	Aneuploidy for chromosomes 3, 7, and 17 and loss of the 9p21 locus	Multitarget FISH	Diagnosis	72	83	Yes	No	36
UroVysion	Sediment		Multitarget FISH	Monitoring	50–92	72–93	Yes	Yes	37, 38
5-ALA-mediated fluorescent urine cytology	Sediment	Intracellular accumulation of protoporphyrin IV	Fluorescence detection devices	Diagnosis	70–87	68–80	No	No	43, 44
NMP-22	Protein	NuMA	Sandwich ELISA	Surveillance	40	99	Yes	Yes	45
NMP-22 BladderChek	Protein	NuMA	Dipstick immunoassay (POC)	Diagnosis and monitoring	68	79	Yes	No	46
BTA TRAK	Protein	hCFHrp	Sandwich ELISA	Monitoring	57–83	60–92	Yes	No	47, 48
BTA stat	Protein	hCFHrp	Dipstick immunoassay (POC)	Monitoring	58	72–95	Yes	No	47
UBC test	Protein	Cytokeratin 8/18 fragment	Sandwich ELISA	Diagnosis	64	80	No	Yes	49
CxBladder Detect	mRNA	IGFBP5, MDK, HOXA13, CDK1, and CXCR2	RT-PCR	Diagnosis	82	85	Yes	No	61
CxBladder Monitor	mRNA	IGFBP5, MDK, HOXA13, CDK1, and CXCR2	RT-PCR	Monitoring	91	96 (NPV)	Yes	No	62
Xpert Bladder Cancer Detection	mRNA	ABL1, CRH, IGF2, UPK1B, and ANXA10	RT-PCR	Diagnosis	77	85	Yes	No	64
Xpert Bladder Cancer Monitor	mRNA	ABL1, CRH, IGF2, UPK1B, and ANXA10	RT-PCR	Monitoring	84	91	Yes	No	65
FGFR3 gene mutation	DNA	FGFR3	PCR	Diagnosis	46% (Ta tumor) 53% (low-grade tumor)	NA	No	No	59
FGFR3 gene mutation	DNA	FGFR3	PCR	Monitoring	78	100	No	No	53

Abbreviations: 5-ALA, 5-aminolevulinic acid; BTA, bladder tumor antigen; FDA, US Food and Drug Administration; FISH, fluorescence in situ hybridization; NPV, negative predictive value; POC, point-of-care; RT-PCR, reverse transcription-PCR; TURBT, transurethral resection of bladder tumor; UBC, urine bladder cancer.