Ordering Recommendation

May aid in diagnosis of urothelial carcinoma and monitoring for tumor recurrence.

Mnemonic
UF REQUEST
Methodology

Fluorescence in situ Hybridization/Computer Assisted Analysis/Microscopy

Performed

Mon-Fri

Reported

4-12 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Second-morning, clean-catch voided urine specimen in UroVysion FISH Collection Kit (ARUP Supply #41440) available online through eSupply using ARUP Connector contact Client Services at (800) 522-2787. For specific instructions refer to Specimen Collection & Handling.

Specimen Preparation

Transport the entire collection in the original collection kit. (Min: 35 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Specimens in inappropriate fixative. Specimens submitted in expired reagents.

Remarks

Submit source information with the specimen.

Stability

Ambient: Unacceptable; Refrigerated: 72 hours; Frozen: Unacceptable

Reference Interval

Negative: No evidence of numeric chromosomal aberrations associated with urothelial carcinoma identified.
Positive: Numeric chromosomal aberrations associated with urothelial carcinoma identified.

Interpretive Data

Negative: Negative results indicate a lack of evidence for the presence of numeric chromosomal abnormalities commonly associated with urothelial carcinoma, within the cells collected in this specimen. Negative results in the presence of other symptoms/signs of urothelial carcinoma may suggest the possibility of a false-negative result. In this circumstance, additional clinical studies to exclude urothelial carcinoma should be pursued as clinically indicated. Although the UroVysion Kit was designed to detect genetic abnormality associated with most urothelial cancers, there will be some urothelial cancers for which genetic changes cannot be detected by the UroVysion Test.

Positive: Positive results indicate the presence of one or more numeric chromosomal abnormalities commonly associated with urothelial carcinoma, within the cells collected in this specimen. Positive results in the absence of clinical documentation of urothelial carcinoma within the bladder suggest the possibility of urothelial carcinoma or other urologic malignancy from another site (including ureter, kidney, urethra, and prostate). In this circumstance, further clinical evaluation to exclude these as a source of the abnormal cells is justified.

The UroVysion Bladder Cancer Kit (UroVysion Kit) is approved for use by the U.S. Food and Drug Administration.

Compliance Category

FDA

Note
Hotline History
N/A
CPT Codes

88121; if manual 88120

Components
Component Test Code* Component Chart Name LOINC
2000594 Clinical History 11329-0
2000608 Gross Description
2001221 UroVysion FISH Specimen Source 31208-2
8100630 Fixative 8100-0
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • Bladder Cancer
  • Bladder Cancer FISH
  • Bladder Tumor
  • Bladder Tumor FISH
  • Cytology
  • FISH
  • Urinary Tract Cancer
  • Urothelial Carcinoma
  • Urovysion
UroVysion FISH