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Test ID NBLD0297 UroVysion for Detection of Bladder Cancer, Urine

Important Note

Effective 7/23/2021: Due to high specimen volumes and staffing impacts, the UroVysion for Detection of Bladder Cancer test will have TAT delays significantly beyond what is published. All specimens will be stabilized and performed/reported as soon as possible. Please anticipate an extended TAT of cases by up to 5 weeks longer than published TAT of cases. Please share this information with ordering physicians for awareness as they schedule collection of these specimens. An update will be provided once testing TAT returns to normal.

Useful For

Monitoring for tumor recurrence in patients with a history of urothelial carcinoma involving the bladder or upper urinary tract

 

Assessing patients with hematuria for urothelial carcinoma

Specimen Type

Varies


Necessary Information


1. Specimen source is required on request form (ie voided, catheterized, bladder washing).

2. Provide fixative, source, reason for referral (evaluate for urothelial carcinoma or hematuria) and status of diagnosis (known previous diagnosis or suspected/unknown).



Specimen Required


Specimen Type: Urine

Sources: Voided urine, catheterized urine, bladder washings, stoma collections, ureteral brushings or washings, renal pelvic brushings or washings

Supplies: FISH for Urothelial Carcinoma Urine Collection Kit (T509)

Container/Tube:

Preferred: FISH for Urothelial Carcinoma in Urocyte Urine Collection Kit

Acceptable: 70% ethanol, PreservCyt, CytoLyt, ThinPrep UroCyte (UroCyte PreservCyt Solution)

Specimen Volume: 30 mL

Collection Instructions:

1. Follow instructions included with Urocyte Urine Collection Kit.

2. If kit is not used, submit a random urine specimen with an equal volume of 70% ethanol, PreservCyt, or CytoLyt.


Specimen Minimum Volume

See Specimen Required

Reject Due To

Unfixed specimens 48 hours after collection Reject

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred)
  Ambient 

Day(s) Performed

Monday through Friday

Report Available

7 to 10 days

Method Name

Fluorescence In Situ Hybridization (FISH) using DNA Probes

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

88120

Special Instructions

Reporting Name

UroVysion (R) for Bladder Cancer

Reference Values

An interpretive report will be provided.

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

Forms

1. Pathology/Cytology Information (T707) in Special Instructions

2. If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.

Sanford Laboratories - Fargo Additional Information:

SANFORD INTERFACE BUILD INFORMATION

Result Code Result Code Description
19110 Result Summary
19111 Result
19112 Interpretation
19113 Reason for Referral
19114 Specimen
19115 Source
19116 Released By