Intended Use

The Vysis D7S486/CEP7 FISH Probe Kit is intended to detect the copy number of the LSI D7S486 and CEP 7 probe targets located at chromosome 7q31 and 7p11.1-q11.1, respectively.

The Vysis LSI D7S486 SpectrumOrange/CEP 7 SpectrumGreen Probes are a mixture of a SpectrumOrange D7S486 probe (7q31) and a SpectrumGreen CEP 7 probe (7p11.1-q11.1). The LSI D7S486 probe target is approximately 308 kb in length (chr7:115462602-115770704; March 2006 UCSC Human Genome Browser). The CEP 7 probe targets the D7Z1 alpha satellite sequence at the centromere of chromosome 7.

Limitations

• FOR IN VITRO DIAGNOSTIC USE
• Individual laboratories should establish an analytical normal cut-off for the abnormal signal pattern(s) of interest.
• If a specimen has a low level abnormal FISH pattern, careful review is recommended including use of the appropriate single pass filter to confirm the pattern.
• Interpretation of FISH results should be made using appropriate controls and analytical techniques as well as taking into consideration other clinical and diagnostic test data.

Caution

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.

To learn more about the Vysis LSI D7S486/CEP 7 FISH Probe Kit please visit: https://www.molecular.abbott/us/en/products/oncology/vysis-d7s486-cep-7-fish-probe-kit