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The Vysis CLL FISH Probe Kit is intended to detect deletion of the LS1 TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence in peripheral blood specimens from untreated patients with B-cell chronic lymphocytic leukemia (CLL). The assay may be used to dichotomize CLL (the 13q-, +12, or normal genotype group versus the 11q- or 17p- group) and may be used as an aid in determining disease prognosis in combination with additional biomarkers, morphology, and other clinical information. The Vysis CLL FISH Probe Kit is not intended for use in selection of therapy or in monitoring of residual disease.

The Vysis CLL FISH Probe Kit uses fluorescence in situ hybridization (FISH) DNA probe technology to determine deletions of the locus-specific identifier (LSI) TP53, LSI ATM, and LSI D13S319 probe targets and gain of the D12Z3 sequence. The Vysis CLL FISH Probe Kit (List No. 4N02-020) consists of two DNA FISH probe sets and three general purpose reagents sufficient to process 20 assays. - . LSI TP53 SpectrumOrange/ATM SpectrumGreen Probe - LSI D13S319 SpectrumOrange/13q34 SpectrumAqua/CEP 12 SpectrumGreen Probe . - DAPI II Counterstain . - NP-40 . - 20X SSC Salt .

The CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe Kit is designed to be an adjunct to standard cytogenetic analysis for in vitro diagnostic use in identifying and enumerating chromosome 12 via fluorescence in situ hybridization (FISH) in interphase nuclei of cells obtained from peripheral blood lymphocytes in patients with chronic lymphocytic leukemia (CLL). Results from the CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe Kit are intended for use in conjunction with standard cytogenetics and for further assessing the trisomy 12 status in normal and abnormal tissue specimens characterized by standard cytogenetics, in patients with and/or without clinical symptoms of CLL. It is not intended to be a stand alone assay for test reporting.

The CEP 12 SpectumOrange DNA Probe is a SpectumOrange fluorescent labeled DNA probe specific for the centromeric region of chronosome 12. This assey is designed IDN provide a rapid and reliable method for the desertion and quantification of chromosome 12 In interphase nuclei by fluorescence in situ hybridization (FISH).