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Bladder Cancer, FISH

Message
Order Uncoded, Miscellaneous with Quest test number 10107.


Test Code
10107


Alias/See Also
Urovysion; Urovysion FISH; FHURO; 10107


CPT Codes
88121

Preferred Specimen
Collection Kit for Urine Cytology or UroVysion FISH Testing


Minimum Volume
33 mL


Other Acceptable Specimens
None


Instructions
Urine (preferred): A urine preservative transport kit, with handling instructions, is available upon request. Perform urine collection (50 mL) at the physician's office or Patient Service Center (PSC) in a sterile 100 mL urine specimen container. Mix voided urine with CytoLyt® or ethanol 50% in a 1:1 solution. Alternatively, mix urine with preservative Carbowax™ (2% polyethylene glycol in 50% ethanol) 2:1 (v:v).
Bladder washings (acceptable): Perform bladder washing collection (50 mL) at the physician's office in a sterile 100 mL urine specimen container. Mix bladder washing with CytoLyt® or ethanol 50% in a 1:1 solution. Alternatively, mix bladder washing with preservative Carbowax™ (2% polyethylene glycol in 50% ethanol) 2:1(v:v).

It is recommended that specimens be processed within 72 hours of collection. Samples received without preservative will be assayed; any study under these conditions yielding insufficient cells or an abnormal result should have a follow-up study with urine in a preservative. Cold packs are recommended during transportation. If bladder washing is not shipped immediately after collection, refrigerate immediately (DO NOT FREEZE). Under no circumstances should bladder-washing specimens be stored or shipped at temperatures at or above 37°C.

Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not reject. Do not freeze.


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Room temperature: See instructions
Refrigerated: See instructions
Frozen: See instructions


Methodology
Fluorescence in situ Hybridization (FISH)

FDA Status
The analytical performance characteristics of this assay have been determined by Quest Diagnostics Nichols Institute. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Daily; Report available: 4 days after receipt at the performing laboratory. Add two (2) days for transport.


Reference Range
See Laboratory Report


Clinical Significance
UroVysion® FISH, detects aneuploidy of chromosomes 3,7,17 and loss of 9p21 locus. Useful for monitoring bladder cancer and in the initial diagnosis of bladder cancer in patients with hematuria.


Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153


Last Updated: August 31, 2023


The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.