UROVYSION FISH-BLADDER CANCER TESTING

Code

000.0000

Name

UROVYSION FISH-BLADDER CANCER TESTING

Category

None

Department

Send-Out

Start Date

Expiration Date

Synonyms

Bladder Cancer FISH, Urinary Tract Cancer, FISH, Urothelial Carcinoma, FISH

CPT Codes

88121

Site

SBMF

Reference Test

44263

Patient Instructions

Contact SBLHC laboratory before collection.
Specimen: Urine or Bladder Wash collected with UroVysion collection kit.

Within 30 minutes of collection, carefully pour 60.0 mL of well-mixed urine into a UroVysion™ Collection Cup containing 30.0 mL of Carbowax Preservative – provided by SBMF (this is a 2:1 mixture of urine to preservative).

Place the preserved sample plus the absorbent pads from the kit into a biohazard bag and securely seal the bag.

Refrigerate the sample and ship on ice packs within 24 hours of collection.

Sample must be received by SBMF and processed within 72 hours of collection.

Reference Range

Negative: No evidence of numeric chromosomal aberrations associated with urothelial carcinoma identified.
Positive: Numeric chromosomal aberrations associated with urothelial carcinoma identified.
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 test. In this circumstance, additional clinical studies to exclude urothelial carcinoma should be pursued, as clinically indicated. Although the Vysis® 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.

Methodology

Fluorescence in situ Hybridization
Automated Image Analysis or Manual Screening