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
ATLAS Test Code

Specimen Information

Type

***CALL LAB FOR INSTRUCTIONS AND SUPPLIES***
Urine, second-morning, clean-catch void
Urine collection system and transport tube, Saccomanno, ThinPrep® UroCyte Urine Collection Kit or PreservCyt® fixative, and a Cytology test request form.
UroVysion™ FISH Collection Kits fixative can be ordered through Client Services

Volume

60 ml

Transport Info

3 days refrigerated (2-8°C) (must be fixed with Saccomanno or PreservCyt® fixative)

Fasting Required?
False
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

Clinical Significance

Results of the UroVysion™ test are intended for use, in conjunction with standard diagnostic procedures, as an aid for initial diagnosis of transitional cell carcinoma in symptomatic patients and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

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