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.

Indications and Limitations of Use

Intended 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.

Limitations

• The CEP 8 SpectrumOrange DNA Probe Kit has been characterized only for identifying chromosomes in nuclear preparations or metaphase spreads from bone marrow specimens.
• The clinical interpretation of any test results should be done in conjunction with standard cytogenetic analysis and should be evaluated within the context of the patient's medical history and other diagnostic laboratory test results.
• Clinical specimens with >2.2% tri-signaled nuclei are considered to have an abnormal trisomy 8 clone. Those with ≤ 2.2% tri-signaled nuclei should be considered normal, although the presence of trisomy 8 is not completely excluded.
• The CEP 8 SpectrumOrange DNA Probe Kit is not intended for long term cell cultured materials such as amniocytes, fibroblasts and tumor cells.
• FISH assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate.
• If significant peripheral blood contamination is present in the bone marrow specimen, the blood may dilute the specimen; it is important to recognize the potential effects this dilution effect may have on the FISH assay results.
• It is possible that patients may have chromosome polymorphism which may hybridize with CEP 8 probe. FISH metaphase analysis should be done in addition to FISH interphase analysis. Polymorphism was not investigated in the clinical trials.
• This assay will not detect the presence of other chromosome abnormalities frequently associated with hematological disorders.
• The efficacy of this assay for monitoring of trisomy 8 or disease progression has not been demonstrated.

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.