For In Vitro Diagnostic Use
The Vysis CEP 8 SpectrumOrange DNA Probe Kit is a SpectrumOrange labeled probe specific for the alpha satellite (centromeric) region, 8p11.1-q11.1.
For Information Only - Not a Controlled Copy
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:
CEP 8 SpectrumOrange DNA Probe Kit Contents
Each CEP 8 SpectrumOrange DNA Probe Kit includes:
Control slides for the CEP 8 SpectrumOrange DNA Probe kit are also sold separately. See Order No. 07J21-001 and Order No. 07J21-002.
Indications and Limitations of 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.
CAUTION: United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; use is restricted to, by, or on the order of a physician.
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