ARUP's Laboratory Test Directory

UroVysion™ FISH : 8100600
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Additional Technical Information
  


Mnemonic: UF

Methodology: Fluorescence in situ Hybridization/Computer Assisted Analysis/Microscopy
Performed: Weekly
Reported: 4-12 days
Specimen Required: Patient Prep: Indications: The UroVysion™ Bladder Cancer Kit (UroVysion™ Kit) is 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.

Collect: A minimum of 35 mL of voided urine specimens.

Supplies: Urine collection system and transport tube, Saccomanno, ThinPrep® UroCyte Urine Collection Kit or PreservCyt® fixative, and a Cytology test request form. UroVysion™ FISH Collection Kits fixative can be ordered through ARUP Client Services at (800) 522-2787 or (801) 583-2787 extension 2170.

Collection Procedure: For purposes of obtaining the greatest yield of diagnostic material, a second-morning, clean-catch voided urine specimen should be collected, if possible. Mix voided urine 2:1 with Saccomanno or PreservCyt® fixative and transfer to a screw-top transport tube. If there is more than 60 mL of urine, the remaining urine can be submitted in an additional container of Saccomanno or PreservCyt® fixative. The specimen should be labeled with the patient's first and last name, date of birth, specimen source, medical record number (or other unique identifier), and collection date. Submit the specimen along with the completed Cytology request form to the Cytopathology Laboratory. Specimen needs to be stored and transported refrigerated. The specimen must be accompanied by a Cytology test request form with the requested test marked and pertinent clinical history recorded.

Unacceptable Conditions: Refrigerated specimens not fixed in Saccomanno or PreservCyt®. Urine volume less than 35 mL.

Stability (collection to initiation of testing): Refrigerated: 72 hours (must be fixed with Saccomanno or PreservCyt® fixative)
Reference Interval:
Negative: No evidence of numeric chromosomal aberrations associated with urothelial carcinoma identified.
Positive: Numeric chromosomal aberrations associated with urothelial carcinoma identified.
Interpretive Data: Negative: Negative results indicate a lack of evidence for the presence of numeric chromosomal abnormalities commonly associated with urothelial carcinoma, within the cells collected in this specimen. Negative results in the presence of other symptoms/signs of urothelial carcinoma may suggest the possibility of a false-negative test. In this circumstance, additional clinical studies to exclude urothelial carcinoma should be pursued, as clinically indicated. Although the Vysis® UroVysion™ Kit was designed to detect genetic abnormality associated with most urothelial cancers, there will be some urothelial cancers for which genetic changes cannot be detected by the UroVysion™ Test.

Positive: Positive results indicate the presence of one or more numeric chromosomal abnormalities commonly associated with urothelial carcinoma, within the cells collected in this specimen. Positive results in the absence of clinical documentation of  urothelial carcinoma within the bladder suggest the possibility of urothelial carcinoma or other urologic malignancy from another site (including ureter, kidney, urethra, and prostate). In this circumstance, further clinical evaluation to exclude these as a source of the abnormal cells is justified.

The Vysis® UroVysion™ Bladder Cancer Kit (UroVysion™ Kit) is approved for use by the U.S. Food and Drug Administration.

The UroVysion™ Bladder Cancer Kit (UroVysion™ Kit) is 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.
CPT Code(s): 88121; If manual: 88120
Cross References: Bladder Cancer FISH (UroVysion™ FISH) , Urinary Tract Cancer (UroVysion™ FISH) , Urothelial Carcinoma (UroVysion™ FISH)