Vysis CEP 12 SpectrumOrange Direct Labeled Fluorescent DNA Probe Kit

For more information, contact Abbott.


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 to be used as a stand alone assay for test reporting; FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, using the same patient specimen. The CEP 12 assay has not been validated for purposes other than those described above. 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.

This kit contains:

  • CEP 12 DNA probe pre-denatured in hybridization buffer (1 vial, 220 µL/vial)
  • NP-40 detergent for wash solution (1 vial, 1 mL/vial)
  • DAPI II counterstain (1 vial, 300 µL/vial)
  • 20X Standard Sodium Citrate (SSC) Salt (1 bottle, 66 g)

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In a normal cell, the expected pattern for CEP 12 is the two orange (2O) signal pattern. In an abnormal cell containing trisomy 12, the expected pattern will be the three orange (3O) signal pattern.

Normal Hybridization: CEP 12 SpectrumOrange hybridized to a normal cell showing two orange signals indicating two copies of chromosome 12.