The CEP X SpectrumOrange/Y SpectrumGreen DNA Probe Kit is intended to detect alpha satellite sequences in the centromere region of chromosome X and satellite III DNA at the Yq12 region of chromosome Y in conjunction with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating chromosomes X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow specimens in subjects who received opposite-sex bone marrow transplantation for chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), myeloproliferative disorder (MPD), myelodysplastic syndrome (MDS), acute and lymphoid leukemia (ALL), or hematological disorder not otherwise specified (HDNOS). 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 from standard cytogenetic analysis, performed concurrently, using the same patient specimen. This device is not intended for use in subjects with like-sex bone marrow transplants; with matrices other than unstimulated, cultured bone marrow specimens; or in screening for constitutional X and Y chromosome aneuploidies.

The CEP X DNA probe (DXZ1 locus) is a SpectrumOrange directly labeled fluorescent DNA probe specific for the AT rich alpha satellite DNA sequence at the centromeric region of chromosome X (Xp11.1- Xq11.1). The CEP Y DNA probe (DYZ1 locus) is a SpectrumGreen directly labeled fluorescent DNA probe specific for the satellite III DNA at the Yq12 region of chromosome Y. This assay is designed for the detection and quantification of chromosomes X and Y in both interphase nuclei and metaphase spreads by FISH.