The CEP 12 SpectrumOrange DNA Probe Kit is intended to detect AT rich alpha satellite sequences in the centromere region of chromosome 12 in conjunction with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating chromosome 12 via fluorescence in situ hybridization (FISH) in interphase nuclei of cells obtained from peripheral blood lymphocytes in patients with B-cell chronic lymphocytic leukemia (CLL). It is not intended for use with test matrices other than peripheral blood lymphocytes from subjects with CLL, to screen for chromosome 12 aneuploidy, eg, in asymptomatic individuals, or to monitor patients for residual disease.
Chronic Lymphocytic Leukemia