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Product summary

  • Technology FISH
  • Application Hematology
  • Areas of interest AML, MDS
  • Region 17p13
    17p11.1-q11.1
  • Label    
  • Product No. USA-LPH 017 (10 tests)
  • Intended use For in vitro diagnostic use. Rx only.

Chromomaps

Overview

Probe specification

  • P53, 17p13, Texas Red
  • D17Z1, 17p11.1-q11.1, FITC Green

The P53 (TP53) Deletion FISH Probe Kit consists of a 161kb probe, labeled in Texas Red, covering the whole P53 (TP53) gene, extending 74kb telomeric to the gene and covering a region centromeric to the gene, to just beyond the marker D17S655; and a probe, labelled in FITC green, covering the chromosome 17 centromere (D17Z1) region.

 

Probe information

The TP53 (tumor protein p53) gene at 17p13 is a tumor suppressor gene that has been shown to be deleted in a wide range of human malignancies. In acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), TP53 loss is associated with a poor outcome and is often seen as a marker of disease progression or secondary disease1,2.

Intended use

The P53 (TP53) Deletion FISH Probe Kit is a fluorescence in situ hybridization (FISH) Test used to detect deletion of the P53 (TP53) region on chromosome 17 at location 17p13 in fixed bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The test is indicated for characterization of patient specimens consistent with World Health Organization (WHO) guidelines for Classification of Tumours of Haematopoietic and Lymphoid Tissues (Revised 4th Edition) and in conjunction with other clinicopathological criteria. The assay results are intended to be interpreted by a qualified pathologist or cytogeneticist. The test is not intended for use as a stand-alone diagnostic, disease screening, or as a companion diagnostic.

 

Limitations of the procedure

For In Vitro Diagnostic Use. Rx only.

Reporting and interpretation of FISH results should be consistent with professional standards of practice and should take into consideration other clinical and diagnostic information. This kit is intended as an adjunct to other diagnostic laboratory tests and therapeutic action should not be initiated on the basis of the FISH result alone. Failure to adhere to the protocol may affect the performance and lead to false results.

Each lab is responsible for establishing their own cut-off values. Each laboratory should test sufficiently large number of samples to establish normal population distribution of the signal levels and to assign a cut-off value. The product is for professional use only and is intended to be interpreted by a qualified Pathologist or Cytogeneticist.

For sale in the US only. This product has not been licensed in accordance with Canadian law.

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References

  1. Grimwade D et al., Blood. 2010;116(3):354–65
  2. Seifert H et al., Leukaemia. 2009;23(4):656–63

Recommended protocol and sample preparation

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Sample and slide preparation

Sample and slide preparation Thumbnail
  • The FISH probes for AML/MDS are designed for use on bone marrow cells fixed in Carnoy’s solution (3:1 methanol/ acetic acid) that are prepared according to the laboratory or institution guidelines.
  • Spot the cell sample onto a glass microscope slide. Allow to dry.
  • Immerse the slide in 2x Saline Sodium Citrate (SSC) for 2 minutes at room temperature (RT) without agitation.
  • Dehydrate in an ethanol series (70%, 85% and 100%), each for 2 minutes at RT.
  • Allow to dry.

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