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UroVysion® Bladder Cancer Assay by FISH

Urine FISH Test, UroVysion Fluorescent in-situ Hybridization (FISH) Assay for Bladder Cancer.

Test Codes

EPIC: LAB6372

Department

Advanced Diagnostics

Instructions

Containers with preservative for UroVysion^® collection can be obtained from Beaumont Laboratory by contacting 800-551-1155.

Specimen Collection Criteria

Collect: 30-100 mL urine specimen (voided, cystoscopy specimen) in provided specimen container.

• Specimens collected in containers without preservative may be poured into a UroVysion^® container (with preservative). Pour 30-100 mL urine specimen into the UroVysion^® container. 
• If no UroVysion^® container is available, specimens submitted in plain urine collection containers will be accepted. Collect specimen in a sterile urine collection containers and keep refrigerated (2-8°C or 36-46°F). Specimens without preservative should be received within 24 hours. Adequacy of such specimens will be evaluated by the Laboratory. 
• Label the specimen container with the patient name. The specimen must be accompanied by a completed requisition and must contain the patient name, date of birth, collection date, ordering physician, and source of specimen. 

Physician Office/Draw Specimen Preparation

Maintain specimens refrigerated (2-8°C or 36-46°F) until transport. Specimens not in preservative must be received in the Laboratory within 24 hours. Specimens in preservative should be received in the Laboratory within 72 hours.

Preparation for Courier Transport

Transport: Urine specimen, refrigerated (2-8°C or 36-46°F).

Rejection Criteria

• Improper labeling, inadequate information. 
• Frozen specimens or specimens at a temperature above 37°C. 
• Improper storage. 
• Urine contaminated with bacteria or fungi. 
• Samples with less than 30 mLs.
• Samples not in proper collection containers (i.e. conical tubes, vaccutainers, etc.) .
• All samples should be submitted to the Advanced Diagnostics Laboratory for evaluation. Specimen adequacy will be determined by the Laboratory. 

Inpatient Specimen Preparation

Maintain specimens refrigerated (2-8°C or 36-46°F) until testing. Do not freeze specimens.

In-Lab Processing

Maintain specimens refrigerated (2-8°C or 36-46°F) until testing. Do not freeze specimens.

Storage

Specimen Stability for Testing:

Unpreserved Specimens
Room Temperature (20-26°C or 68-78.8°F): Unacceptable
Refrigerated (2-8°C or 36-46°F): 24 hours
Frozen (-20°C/-4°F or below): Unacceptable

Preserved Specimens
Room Temperature (20-26°C or 68-78.8°F): Unacceptable
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal: 

Refrigerated (2-8°C or 36-46°F): 7 days

Laboratory

Royal Oak Anatomic Pathology – Advanced Diagnostics Laboratory.

Performed

Twice per week.
Results available in 4-7 days.

Test Methodology

Fluorescence in-situ Hybridization technique utilizing UroVysion^® FISH kit from Abbott.

Interpretation

Positive/Negative/Indeterminate/Quantity not Sufficient.

Clinical Utility

Detects transformed, neoplastic urothelial cells.

The UroVysion^® Bladder Cancer Kit is designed to detect aneuploidy for chromosomes 3, 7, and 17 and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from patients 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 in the diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

CPT Codes

88121

Contacts

Last Updated

1/10/2024