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Product summary

  • Technology FISH
  • Application Hematology
  • Areas of interest MDS
  • Region 20q12
    20q13.1
  • Label    
  • Product No. USA-LPH 020 (10 tests)
  • Intended use For in vitro diagnostic use. Rx only.

Chromomaps

Overview

Probe specification

  • 20q12, Texas Red
  • 20q13.1, FITC Green

The Del(20q) Deletion FISH Probe Kit consists of a 331kb probe, labeled in Texas Red, covering a region within the PTPRT gene and including the D20S108 marker; and two (141kb and 174kb) probes labeled in FITC green covering the MYBL2 gene and including the D20S150 marker.

 

Probe information

Deletions of the long arm of chromosome 20 are recognized as recurrent chromosomal abnormalities associated with myelodysplastic syndromes (MDS)1. The prognosis for MDS where del(20q) is the sole abnormality is good; however, the presence of secondary abnormalities may be indicative of disease progression2.

Intended use

The Del(20q) Deletion FISH Probe Kit is a fluorescence in situ hybridization (FISH) Test used to detect deletion within the long arm of chromosome 20 at locations 20q12 and 20q13.1, in fixed bone marrow specimens from patients with 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. Brezinova J et al., Cancer Genet Cytogenet. 2005 Jul;160(2):188–92
  2. Liu Y-C et al., Cancer Genet Cytogenet. 2006 Nov;171(1):9–16

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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