Bladder Cancer, FISH [10107X]

Test Code
10107

CPT Codes
88121

Preferred Specimen
Minimum: 50 mL urine (≥33 mL voided urine mixed 2:1 with PreservCyt®) transferred into a tightly-capped plastic container

Other Acceptable Specimens
Bladder washing submitted in a sterile, leak-proof container (see instructions)

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.

Transport Temperature
Refrigerated (cold packs)

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

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: Sun-Fri a.m.; Report available: 4 days

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

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.