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Test Code UROVY UroVysion for Detection of Bladder Cancer, Urine

Reporting Name

UroVysion (R) for Bladder Cancer

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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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, and 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 (T509)

Acceptable: 70% ethanol, PreservCyt, CytoLyt

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

30 mL is recommended, however, will not reject if <30 mL

Specimen Stability Information

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

Special Instructions

Reference Values

An interpretive report will be provided.

Day(s) and Time(s) Performed

Monday through Friday; 6 a.m.-8 p.m.

Saturday; 10 a.m.-6:30 p.m.

Sunday; 1 p.m.-9:30 p.m.

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 U.S. 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

Clinical Reference

1. Halling KC, Kipp BR: Bladder Cancer Detection Using FISH (UroVysion Assay). Adv Anat Pathol 2008:15(5):279-286

2. Gayed BA, Seideman C, Lotan Y: Cost-effectiveness of fluorescence in situ hybridization in patients with atypical cytology for the detection of urothelial carcinoma. J Urol. 2013 Oct;190(4):1181-1186

Method Description

Urinary cells are harvested, fixed, and placed on a slide. The UroVysion probe set, which contains fluorescently labeled DNA probes specific to the centromeres of chromosomes 3, 7, 17, and to the 9p21 locus is hybridized to the cells on the slide. The slide is washed and counterstained with DAPI stain. Fluorescence microscopy with unique band filters is then used to scan the slide for atypical cells (eg, cells with nuclear enlargement or irregularity). These cells are assessed for gains of chromosomes (3, 7, 17) or homozygous 9p21 deletion. If the number of cells with chromosomal gains (polysomy or trisomy) or homozygous 9p21 deletion observed on scanning is sufficient to consider the test result positive, the percentage of transitional cells with polysomy, trisomy, or homozygous 9p21 deletion is determined.(Halling KC, King W, Sokolova IA, et al: A comparison of cytology and fluorescence in situ hybridization for the detection of urothelial carcinoma. J Urol 2000;164:1768-1775; Sokolova IA, Halling KC, Jenkins RB, et al: The development of a multi-target, multi-color fluorescence in situ hybridization assay for the detection of urothelial carcinoma in urine. J Mol Diagn 2000;2:116-123)

Analytic Time

4 days

Reject Due To

No specimen should be rejected.

Method Name

Fluorescence In Situ Hybridization (FISH) Using DNA Probes

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.