CEP® 8 SpectrumOrangeTM Direct Labeled Fluorescent DNA Probe Kit
Product Description
| Probe Name | Probe Location | Fluorophore |
| CEP 8 | 8p11.1-q11.1 Alpha Satellite DNA | SpectrumOrange TM |
CEP 8 is a SpectrumOrange labeled probe specific for the alpha satellite (centromeric) region, 8p11.1-q11.1.
The CEP 8 DNA Probe Kit which is FDA cleared may be used as an adjunct to standard karotyping to identify and enumerate chromosome 8 in cells obtained from bone marrow. In multi-site clinical trials, the CEP 8 DNA Probe Kit for interphase analysis was 96% sensitive and 98% specific as compared to traditional cytogenetic analysis. A close association has been made between trisomy 8 and both myeloid blast crisis and basophilia. Trisomy 8 is a prevalent genetic aberration in several specific diseases:
The CEP 8 DNA Probe Kit which is FDA cleared may be used as an adjunct to standard karotyping to identify and enumerate chromosome 8 in cells obtained from bone marrow. In multi-site clinical trials, the CEP 8 DNA Probe Kit for interphase analysis was 96% sensitive and 98% specific as compared to traditional cytogenetic analysis. A close association has been made between trisomy 8 and both myeloid blast crisis and basophilia. Trisomy 8 is a prevalent genetic aberration in several specific diseases:
- Chronic Myelogenous Leukemia (CML)
- Acute Myeloid Leukemia (AML)
- Myeloproliferative disorders (MPD)
- Myelodysplastic Syndrome (MDS)
- Other hematologic disorders not specified (includes hyperproliferative states such as polycythemia vera, leukemoid reaction, lymphoproliferative disorders or chronic lymphocytic leukemia)
Results of Hybridization
In a normal cell, the expected pattern for a nucleus hybridized with the CEP 8 probe is a two orange (2O) signal pattern. In an abnormal cell containing trisomy 8, the expected pattern will be a three orange (3O) signal pattern.Components of the CEP 8 SpectrumOrange DNA Probe Kit include:
- CEP 8 SpectrumOrange alpha satellite DNA for centromere region 8p11.1-q11.1 predenatured in hybridization buffer (220 ìL)
- NP-40 (detergent for wash solution: 1000 ìL)
- DAPI II counterstain (300 ìL)
- 20X SSC (66 g)
Control slides for the CEP 8 kit are also sold separately. See Order No. 30-805000 and Order No. 30-805002.
CEP 8 SpectrumOrange hybridized to a normal cell showing two orange signals indicating two copies of chromosome 8.
References
- Byrd, J., et al. (1998) Clin Cancer Res 4, 1235-41.
- Escudier, S., et al. (1993) Blood 81, 2702-7.
- Heim, S. & Mitelman, F. (1995) Cancer Cytogenetics 2nd ed. New York City, NY, John Wiley & Sons.
- Jenkins, R., et al. (1992) Blood 79, 3307-15.
- Najfeld, V., et al (1997) Bone Marrow Trans 19, 829-34.
Order Information
| Product Name | Package Size | Vysis® Order Number | Abbott Order Number |
| CEP 8 SpectrumOrange Direct Labeled Fluorescent DNA Probe Kit (without control slides) | 20 Assays | 30-160008 | 07J20-008 7J20
|
| CEP 8 SpectrumOrange Direct Labeled Fluorescent DNA Probe Kit (with control slides) | 20 Assays | 32-160008 | 07J22-008 7J22
|
For In Vitro Diagnostic Use.
The CEP 8 SpectrumOrange DNA Probe Kit is intended to detect AT rich alpha satellite sequences in the centromere region of chromosome 8 in conjunction with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating chromosome 8 via fluorescence in situ hybridization (FISH) in interphase nuclei and in metaphase spreads of cells obtained from bone marrow in patients with myeloid disorders [Chronic myelogenous leukemia (CML), Acute myeloid leukemia (AML), Myeloproliferative disorder (MPD), Myelodysplastic syndrome (MDS), and Hematological disorders not otherwise specified (HDNOS)]. It is not intended to be used as a stand alone assay for test reporting. It is not intended for use in long term cell cultured materials such as amniocytes, fibroblasts and tumor cells.
The CEP 8 SpectrumOrange DNA Probe Kit is intended to detect AT rich alpha satellite sequences in the centromere region of chromosome 8 in conjunction with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating chromosome 8 via fluorescence in situ hybridization (FISH) in interphase nuclei and in metaphase spreads of cells obtained from bone marrow in patients with myeloid disorders [Chronic myelogenous leukemia (CML), Acute myeloid leukemia (AML), Myeloproliferative disorder (MPD), Myelodysplastic syndrome (MDS), and Hematological disorders not otherwise specified (HDNOS)]. It is not intended to be used as a stand alone assay for test reporting. It is not intended for use in long term cell cultured materials such as amniocytes, fibroblasts and tumor cells.
