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.

CEP 12 SpectrumOrange DNA Probe Kit Contents

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)

The CEP 12 SpectrumOrange DNA Probe Kit is available in two configurations: with control slides (07J22-12) and without (07J20-12).

Control slides for the CEP 12 kit are also sold separately. See Order No. 07J21-001, Order No. 07J21-002.

Limitations

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. The CEP 12 DNA Probe Kit has not been validated for monitoring disease status.
7. 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.
8. 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.

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.