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Test Code FUROC UroVysion for Detection of Bladder Cancer, Urine

Reporting Name

UroVysion (R) for Bladder Cancer

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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

Method Name

Fluorescence In Situ Hybridization (FISH) using DNA Probes


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 Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

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

Reject Due To

Unfixed specimens 48 hours after collection Reject

Reference Values

An interpretive report will be provided.

Interpretation

Lower Tract Samples:

Abnormal: any specimen satisfying 1 of the following criteria:

-Four or more cells with gains of 2 or more chromosomes

-Ten or more cells with a gain of a single chromosome or 10 or more cells with tetrasomic signal patterns (ie, 4 copies for each of the 4 probes)

-Homozygous deletion of the 9p21 locus in 20% or more of the cells analyzed

 

For cases that are abnormal, the percentage of abnormal cells and type of chromosomal abnormality (ie, polysomy, trisomy, tetrasomy, or homozygous 9p21 deletion) are indicated in the test report.

 

Negative:

-Fewer than 4 cells with gains of 2 or more chromosomes

-Fewer than 10 cells with gain of a single chromosome or tetrasomy

-Less than 20% of cells with homozygous 9p21 deletion

 

Upper Tract Samples:

Abnormal: any upper tract specimen satisfying 1 of the following criteria:

-Four or more hypertetrasomy cells with at least 5 copies of 2 or more chromosomes

-Ten or more cells with a gain of a single chromosome or 10% or more cells with tetrasomic or near-tetrasomic signal patterns (ie, 4 copies for each of the 4 probes)

-Homozygous deletion of the 9p21 locus in 20% or more of the cells analyzed

 

Negative:

-Fewer than 4 cells with hypertetrasomy with at least 5 copies of 2 or more chromosomes

-Fewer than 10% of cells with tetrasomy

-Less than 20% of cells with homozygous 9p21 deletion

Day(s) Performed

Monday through Friday

Report Available

7 to 10 days

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.

CPT Code Information

88120

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FUROC UroVysion (R) for Bladder Cancer 82251-0

 

Result ID Test Result Name Result LOINC Value
54674 Result Summary 50397-9
54675 Result 82251-0
54676 Interpretation 69047-9
54677 Reason for Referral 42349-1
54678 Specimen 31208-2
54679 Source 31208-2
54680 Released By 18771-6

Forms

1. Pathology/Cytology Information (T707)

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

Special Instructions