Vysis CEP 12 SpectrumOrange Direct Labeled Fluorescent DNA Probe Kit

For more information, contact Abbott.

Contact
Product Name Unit Size Order Number GTIN
Product Description
Results of Hybridization
Product Description

The Vysis CEP 12 SpectrumOrange DNA Probe Kit is intended to detect AT rich alpha satellite sequences in the centromere region of chromosome 12 in conjunction with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating chromosome 12 via fluorescence in situ hybridization (FISH) in interphase nuclei of cells obtained from peripheral blood lymphocytes in patients with B-cell chronic lymphocytic leukemia (CLL). 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 of standard cytogenetic analysis, performed concurrently, using the same patient specimen. The CEP 12 assay has not been validated for purposes other than those described above. It is not intended for use with test matrices other than peripheral blood lymphocytes from subjects with CLL, to screen for chromosome 12 aneuploidy, eg, in asymptomatic individuals, or to monitor patients for residual disease.

This kit contains:

  • CEP 12 DNA probe pre-denatured in hybridization buffer (1 vial, 220 µL/vial)
  • NP-40 detergent for wash solution (1 vial, 1 mL/vial)
  • DAPI II counterstain (1 vial, 300 µL/vial)
  • 20X Standard Sodium Citrate (SSC) Salt (1 bottle, 66 g)
  • Intended Use

    The CEP 12 SpectrumOrange DNA Probe Kit is intended to detect AT rich alpha satellite sequences in the centromere region of chromosome 12 in conjunction with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating chromosome 12 via fluorescence in situ hybridization (FISH) in interphase nuclei of cells obtained from peripheral blood lymphocytes in patients with B-cell chronic lymphocytic leukemia (CLL). 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 of standard cytogenetic analysis, performed concurrently, using the same patient specimen. The CEP 12 assay has not been validated for purposes other than those described above. It is not intended for use with test matrices other than peripheral blood lymphocytes from subjects with CLL, to screen for chromosome 12 aneuploidy, eg, in asymptomatic individuals, or to monitor patients for residual disease.

    Limitations of the Procedures

    • The CEP 12 DNA Probe Kit has been optimized only for identifying chromosome 12 in interphase nuclei from peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia.
    • The clinical interpretation of any abnormality or its absence by FISH should be done in conjunction with standard cytogenetic analysis and proper controls, and should be evaluated within the context of the patient’s medical history and past diagnostic laboratory test results.
    • Clinical specimens with > 2.0% tri-signaled nuclei are considered to have an abnormal trisomy 12 clone. Those with ≤ 2.0% tri-signaled nuclei should be considered normal, although the presence of trisomy 12 is not completely excluded. When the percentage of tri-signaled interphase nuclei are near the cutoff point (1.5 to 2.5%), the results should be interpreted with caution.
    • The CEP 12 assay has been validated only for use with peripheral blood lymphocytes obtained from patients with B-cell CLL leukemia. It is not intended to be used for chromosome 12 enumeration in other patient populations or with other test matrices such as amniocytes, chorionic villi, fibroblasts, tumor cells, long term cultures, among others.
    • FISH assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate; the CEP 12 DNA Probe Kit has been optimized for archived peripheral blood specimens stored only at – 20°C or – 80°C, as recommended.
    • The CEP 12 DNA Probe Kit has not been validated for monitoring disease status.
    • It is possible that some individuals may have target sequences at an alternate chromosomal location that may hybridize with CEP 12. This has not been investigated for this device; the user should assess this in metaphase spreads from each subject tested.
    • The CEP 12 assay is intended only to aid in the enumeration of chromosome 12 centromeres; it is not designed to detect chromosome 12 structural abnormalities.

    Rx Only

    For In Vitro Diagnostic Use

    To learn more about the Vysis CEP 12 SpectrumOrange DNA probe kit please visit: https://www.molecular.abbott/us/en/products/vysis-cep-12-dna-probe-kit

    Results of Hybridization
    In a normal cell, the expected pattern for CEP 12 is the two orange (2O) signal pattern. In an abnormal cell containing trisomy 12, the expected pattern will be the three orange (3O) signal pattern.
    Normal Hybridization: CEP 12 SpectrumOrange hybridized to a normal cell showing two orange signals indicating two copies of chromosome 12.

    You are about to exit the Abbott family of websites for a 3rd party website

    Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. The website that you have requested also may not be optimised for your screen size.

    Do you wish to continue and exit this website?

    Yes No

    You are about to enter an Abbott country or region specific website.

    Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.

    Do you wish to continue and enter this website?

    Yes No