The CEP 8 SpectrumOrange DNA Probe Kit is available for in vitro diagnostic use and 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 SpectrumOrange 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)
• Hematologic Disorders Not Otherwise Specified (HDNOS)

CEP 8 SpectrumOrange DNA Probe Kit Contents

Each CEP 8 SpectrumOrange DNA Probe Kit includes:

• CEP 8 SpectrumOrange alpha satellite DNA for centromere region 8p11.1-q11.1 predenatured in hybridization buffer (220 µL)
• NP-40 (detergent for wash solution: 1000 µL)
• DAPI II counterstain (300 µL)
• 20X Standard Sodium Citrate (SSC) Salt (1 bottle, 66 g)

Control slides for the CEP 8 SpectrumOrange DNA Probe Kit are also sold separately. See Order No. 07J21-001 and Order No. 07J21-002.