Specimen Collection & Shipping

 

Specimen Collection and Transport

  • Use the UroVysion Bladder Cancer Kit on voided urine specimens (greater than or equal to 33 mL) which should be collected at a physician’s office
  • Mix voided urine 2:1 (v:v) with preservative; Carbowax (2% polyethylene glycol in 50% ethanol) or PreservCyt® preservatives are recommended
  • Transfer mixture to a 50 mL centrifuge tube(s) or other tightly-capped plastic container
  • Ship urine immediately after collection, or if this is not possible, refrigerate immediately and ship via overnight courier within 24 hours (preferred storage and shipping conditions are on ice packs, but specimens may be stored and shipped at temperatures up to 25°C)
  • Storing urine in Carbowax or PreservCyt® under these conditions has been shown to keep it stable for 1 week, but it is recommended that specimens be processed to the point of fixed cell pellets within 72 hours of collection
  • Performance characteristics of the UroVysion test under any other conditions must be determined and validated by the user

 

Recommended Specimen Preservatives

  • Carbowax (2% polyethylene glycol in 50% ethanol)
  • ThinPrep™ PreservCyt® Solution, Cytyc Corp.
  • Use of any other preservative must be validated by individual laboratories

 

Intended Use: 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.

 

Warnings and Limitations

  1. The UroVysion Kit has been optimized for identifying and quantitating chromosomes 3, 7, and 17, and locus 9p21 in human urine specimens.
  2. The performance of the UroVysion Kit was validated using the procedures provided in the package insert only. Modifications to these procedures may alter the performance of the assay.
  3. The clinical interpretation of any test results should be evaluated within the context of the patient’s medical history and other diagnostic laboratory test results.
  4. UroVysion assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate, e.g., the presence of excessive granulocytes or massive bacteruria.
  5. Technologists performing the UroVysion signal enumeration must be capable of visually distinguishing between the red and green signals.
  6. Positive UroVysion results in the absence of other signs or symptoms of bladder cancer recurrence may be evidence of other urinary tract related cancers, e.g., ureter, urethra, renal, and/or prostate in males, and further patient follow-up is justified. In a study conducted on patients with hematuria, 3 patients whose initial bladder cystoscopy was negative, were subsequently diagnosed with renal cancer within 6 months of this initial study visit. All 3 of these cases were positive by UroVysion.
  7. If UroVysion results are negative but standard clinical or diagnostic tests (e.g., cytology, cystoscopy) are positive, the standard procedures take precedence over the UroVysion test. Although the UroVysion Kit was designed to detect genetic changes associated with most bladder cancers, there will be some bladder cancers whose genetic changes cannot be detected by the UroVysion test.
  8. Ta stage solitary tumors smaller than 5mm could not be detected by UroVysion FISH. UroVysion FISH results are dependent on the amount of tumor cells that are deposited on the slide.

 

Caution:  United States Federal law restricts this device to sale and distribution to, or on the order of, a physician or a clinical laboratory; use is restricted to, by, or on the order of a physician.

 

Click here to arrange for kit ordering.

Click here  to arrange for specimen shipping.

 

Complete UroVysion Package Insert
Important Safety Information for UroVysion

 

FOR IN VITRO DIAGNOSTIC USE