A
5200 Harry Hines Blvd.
,
Dallas
,
TX
75235
Search Tests
Search by Dept.
General Information
Alias: Fluorescence in situ hybridization, UroVysion, FISH for Recurrent Bladder Cancer
Performed: Mon, Thurs
Turn Around Time: 2-5 days
CPT Codes: 86021
Performed By: Referral Lab
Notes: This test is performed at UTSW. Call UTSW Cytogenetics Lab (214-648-0975) with questions. Generally, Urovysion is performed on a urine cytology diagnosis of Atypical or Suspicious.
Clinical Utility: The UroVysion® Bladder Cancer Kit (UroVysion Kit) is FDA approved and designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
Link:
UroVysion for Detection of Bladder Cancer, Urine
Unacceptable Conditions: Preservcyt® specimen vial exceeding the expiration date printed on the container; Specimens stored or transported outside of required temperature range 39°- 86° F (4-30°C);
Unlabeled specimen containers;
A mismatch between the specimen label and the requisition;
A leaking specimen that is not salvageable
Incomplete requisition;
A specimen received > 72 hours past the date of collection;
A specimen with fewer than 25 evaluable nuclei is reported as Uninformative.
Components
| Name |
Method |
Sex |
Age Range |
Ref. Range Low |
Ref. Range High |
Units |
| UroVysion FISH, Upper Tract Samples |
Fluorescence In Situ Hybridization (FISH) Using DNA Probes |
|
|
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 |
Abnormal: satisfying 1 of the following criteria: >=4 hypertetrasomy cells with at least 5 copies of 2 or more chromosomes; >=10 cells gain of single chromosome or >=10% or more tetrasomic signal pattern; Homozygous deletion of 9p21 in 20% or more cells |
|
| UroVysion FISH, Lower Tract Samples |
Fluorescence In Situ Hybridization (FISH) Using DNA Probes |
|
|
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 |
Abnormal: satisfying 1 of the following criteria: >= 4 cells with gains of 2 or more; >=10 cells with gain of single chromosome or 10 or more cells with tetrasomic signal pattern; Homozygous deletion of 9p21 in 20% or more cells analyzed |
|
Specimen Requirements
| Type |
Container |
Volume |
Units |
Collection / Delivery |
Storage / Transport |
Off Campus |
| Urine (voided or catheterized), Bladder Washing, Ureter or Renal Washing |
Submit specimen to lab in a 100 cc Urinary Fixative Collection container prefilled with 30 mL Preservcyt® (Provided by Cytology). Min Urine vol is 35mL |
|
|
Collect the urinary specimen in a sterile specimen container, then transfer the sample to a prefilled Urinary Fixative collection container (provided by Cytology) that contains Preservcyt (a methanol based fixative). The volume of urinary
specimen transferred to the prefilled Urinary fixative container should be a minimum volume of 35 mL and the total urinary volume should not exceed 66 mL.Specimens should be delivered to the lab within 72 hours of collection. |
Prior to specimen collection, urinary collection containers must be stored at 59-86° F (15-30° C). Once urinary specimen is added to the collection container, the specimens should be kept between 39°- 86° F (4-30°C) |
|