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Beaumont Laboratory

UroVysion ® Bladder Cancer Assay by FISH

Urine FISH Test, UroVysion Fluorescent in-situ Hybridization (FISH) Assay for Bladder Cancer, EPIC: LAB6372, SOFT: MUROG

Instructions

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

Specimen Collection Criteria

Collect: 40-100 mL urine specimen (voided, cystoscopy specimen) in provided specimen container with 40 mL preservative.

  • Specimens collected in containers without preservative may be poured into a UroVysion® container (with preservative). Pour 40-100 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. Adequecy 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/Drawsite 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.
  • A separate specimen container must be submitted for the assay. No split samples or samples in test tubes will be accepted.
  • All samples should be submitted to the Advanced Diagnostics Laboratory for evaluation. Specimen adequecy will determined by the Laboratory.

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.

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 Code

88120.

Test Codes

EPIC: LAB6372, SOFT: MUROG

Last Updated

04/10/2017

Microtainer® and Vacutainer® are registered trademarks of Becton, Dickinson and Company.
UroVysion® is a registered trademark of Abbott Laboratories. ThinPrep® is a registered trademark of Hologic, Incorporated.

This directory currently reflects information only for specimens collected and/or processed at the Farmington Hills, Grosse Pointe, Royal Oak, and Troy campuses.