CEP® X SpectrumOrange/Y SpectrumGreenTM Direct Labeled Fluorescent DNA Probe Kit
Product Description
| Probe Name | Probe Location | Fluorophore |
| CEP X | Xp11.1-q11.1 Alpha Satellite DNA | SpectrumOrange TM |
| CEP Y | Yq12 Satellite III | SpectrumGreen TM |
The CEP X/Y DNA Probe Kit, which is FDA approved, may be used as an adjunct to standard karotyping to evaluate engraftment success in recipients of sex mismatched bone-marrow transplantation by determining the proportion of XX and XY donor cells. Following transplantation, an assessment of the proportion of cells belonging to the donor and to the recipient can be used to evaluate engraftment, detect the presence of clonal neoplasms and determine disease recurrence. This probe kit offers a limit of detection of 1% through a combination of CEP X and CEP Y fluorescently labeled DNA probes for specific regions of chromosome X and chromosome Y, respectively. This probe provides rapid (results in 3 hours or less) and accurate identification of the genetic sex of the bone marrow cells. Bone-marrow transplantation is a critical therapeutic strategy in the management of hematologic malignancies, such as:
Materials Provided With the CEP X/Y DNA Probe Kit:
- Chronic Myelogenous Leukemia (CML)
- Acute Myeloid Leukemia (AML)
- Acute Lymphocytic Leukemia (ALL)
- Myeloproliferative Disorder (MPD)
- Chronic Lymphocytic Leukemia (CLL)
- Myelodysplastic Syndrome (MDS)
- Other hematologic disorders not otherwise specified (including hyper-proliferative states such as polycythemia vera, leukemoid reaction, and lymphoproliferative disorders)
Materials Provided With the CEP X/Y DNA Probe Kit:
- CEP X/Y DNA probe pre-denatured in hybridization buffer (220 µL)
- NP-40 (detergent for wash solution 1000 µL)
- DAPI II counterstain (300 µL)
- 20X SSC (66 g)
Results of Hybridization
In a normal male cell, the expected pattern for a nucleus hybridized with the CEP X/Y DNA Probe is the one orange, one green (1O1G) signal pattern. In a normal female cell the two orange (2O) single pattern for female donor cells will be observed.
Female
Male
References
- Byrd, J., et al. Clin. Cancer Res. 4 (1998): 1235-41.
- Escudier, S., et al. Blood 81 (1993): 2702-7.
- Heim, S., et al. Cancer Cytogenetics 2nd ed. (1995): 377.
- Jenkins, R., et al. Blood 79 (1992): 3307-15.
- Najfeld, V., et al. Bone Marrow Trans. 19 (1997): 829-34.
Order Information
| Product Name | Package Size | Vysis® Order Number | Abbott Order Number |
| Sex Mismatched Bone-Marrow Transplant Management ( BMT) (without control slides) | 20 Assays | 30-161050 | 07J20-050 |
| Sex Mismatched Bone-Marrow Transplant Management ( BMT) (with control slides) | 20 Assays | 32-161050 | 07J22-050 |
For In Vitro Diagnostic Use.
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 fluorescence in situ hybridization (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 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 fluorescence in situ hybridization (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.
