UroVysion

Fresh or CytoLyt fixed specimen in sterile container. No minimum/maximum volume requirements, >10mL preferred. Small volume may limit interpretation.

Collection instructions:
Urine for UroVysion examination should be sent to the laboratory as soon as possible after collection · If a delay of more than 24 hours cannot be avoided, add an equal amount of CytoLyt · Include method of collection on the test requisition form: voided urine, catheterized urine, or bladder lavage. Also indicate if specimen was obtained pre- or post-cystoscopy.

Voided Urine Specimen: A mid-morning specimen is most desirable.
1. Have the patient drink several glasses of water.
2. One hour later, have patient void and save the specimen. Obtain by the "clean catch" method.
3. Repeat on successive days for higher accuracy.
4. Label specimen as "Voided Urine Specimen."

Catheterized Urine Specimen:
1. Have the patient drink several glasses of water.
2. One hour later, obtain a catheterized specimen.
3. Label specimen as "Catheterized Urine Specimen."

Kidney Urine Cytology:
1. Obtain a baseline voided urine prior to urethral catheterization.
2. Kidney urine specimens are collected in surgery.
3. Kidney pelvis washings are obtained by instilling saline solution through catheter and aspirating.
4. Washings with water are not suitable as the cells are lysed.
5. Label specimen as to method of collection. Cytomegalovirus & Polyoma (BK Virus)1. Collect as routine urine or, if from an infant, obtain as much urine as possible.

Bladder Lavage:
1. Fluid obtained by saline lavage of the bladder during cystoscopy must be fixed in an equal amount of cytology collection fluid.

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.

When possible, store specimen at 2°C - 8°C. Specimen may be transported at 15°C - 30°C. Do not freeze.

Specimen containers without two (2) patient identifiers, frozen specimens

7 Days

In general, exfoliated transitional cells from voided or instrumented urine collection specimens are first cytologically examined, and, if the cells are atypical/suspicious for malignancy, the cells are "reflexed" for UroVysion testing.The Vysis® UroVysion™ Bladder Cancer Kit (UroVysion™ Kit) is approved for use by the U.S. Food and Drug Administration.