Ordering Recommendation
May aid in diagnosis of urothelial carcinoma and monitoring for tumor recurrence.
Mnemonic
Methodology
Fluorescence in situ Hybridization (FISH)/Computer Assisted Analysis/Microscopy
Performed
Mon-Fri
Reported
4-12 days
New York DOH Approval Status
Specimen Required
Second-morning, clean-catch voided urine specimen collected in PreservCyt collection vial included in UroVysion FISH Collection Kit (ARUP Supply #41440). Collection kit is available online through eSupply using ARUP Connector contact Client Services at (800) 522-2787. For specific instructions refer to Specimen Collection & Handling.
Specimens must be transported in PreservCyt fixative. Acceptable sources are voided urine, bladder washings, ureteral washings, or urethral washings. (Min: 35 mL)
Ambient or Refrigerated.
Unfixed specimens not in PreservCyt fixative. Frozen specimens. Specimens submitted in expired collection vials.
Submit source information with the specimen.
Ambient: 1 week from collection; Refrigerated: 1 week from collection; 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.
FDA
Note
Hotline History
CPT Codes
88121; if manual 88120
Components
Component Test Code* | Component Chart Name | LOINC |
---|---|---|
2000594 | Clinical History | 22636-5 |
2000608 | Gross Description | 22634-0 |
2001221 | UroVysion FISH Specimen Source | 66746-9 |
8100630 | Fixative | 8100-0 |
Aliases
- Bladder Cancer
- Bladder Cancer FISH
- Bladder Tumor
- Bladder Tumor FISH
- Cytology
- FISH
- Urinary Tract Cancer
- Urothelial Carcinoma
- Urovysion