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For In Vitro Diagnostic Use
The UroVysion Bladder Cancer Kit (UroVysion Kit) is FDA approved and 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.
UroVysion Bladder Cancer Kit Package Insert (PDF – 2.4 MB)For Information Only - Not a Controlled Copy
Urovysion Kit Contents
The UroVysion Bladder Cancer Kit probes are directly labeled with one of the Vysis fluorophores; SpectrumRed, SpectrumGreen, SpectrumAqua or SpectrumGold.
The UroVysion Bladder Cancer Kit consists of:
Indications and Limitations Of 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.
CAUTION: United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; use is restricted to, by, or on the order of a physician.
Vysis Microscope Filter Recommendations
UroVysion probe signals and DAPI counterstain should be viewed with the following Vysis filter sets:
An epi-fluorescence microscope equipped with a 100-watt mercury lamp is strongly recommended. An epi-fluorescence microscope enables a light source to transmit light through the viewing path, replacing the illuminator and condenser of the conventional wide field microscope. For this mode to function, the structures of interest are labeled with a fluorophore. Light from the source is collimated and directed into the tube of the microscope to a 45-degree mirror with an interference coating that lets in light at particular wavelengths and is transparent at other wavelengths (a dichroic mirror). This light is directed to the back of the objective and is focused into the sample. The objective functions as a condenser. Exciting light is absorbed by the fluorophore in the sample. The energy of the absorbed photon causes an electron in the dye molecule to jump to a higher energy orbital state. The electron rapidly jumps back to its ground orbital state, with the energy released becoming a photon of less energy compared to the exciting photon. The emitted photon has a color shifted toward red. The eyepiece collects the image in an identical manner as is transmitted in wide field microscopy.
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