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Product summary

  • Technology FISH
  • Application Haematology
  • Areas of interest AML, MDS
  • Region 5q31.2
  • Label    
  • Product Code CE-LPH 024 (10 tests)
    CE-LPH 024-S (5 tests)
  • Regulatory Status In vitro diagnostic.



Probe specification

  • EGR1, 5q31.2, Red
  • 5p15.3, Green

The EGR1 probe, labelled in red, covers a 186kb region within 5q31.2 that includes the D5S500 marker. The probe mix also contains a control probe, labelled in green for chromosome 5 at 5p15.3 that includes the marker D5S630.


Probe information

Deletions of the long arm of chromosome 5 are one of the most common karyotypic abnormalities reported in myelodysplastic neoplasms and acute myeloid leukaemia, myelodysplasia-related1,2. EGR1 (early growth response 1), a tumour suppressor gene at 5q31.2, has been shown to act through haploinsufficiency to initiate the development of myelodysplasia and acute myeloid leukaemia3.

Intended purpose

The CytoCell® Del(5q) Deletion Probe is a qualitative, non-automated, fluorescence in situ hybridisation (FISH) test used to detect chromosomal deletions in the 5q31.2 region on chromosome 5 in Carnoy’s solution (3:1 methanol/acetic acid) fixed haematologically-derived cell suspensions from patients with confirmed or suspected acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS).


Indications for use

This device is designed as an adjunct to other clinical and histopathological tests in recognised diagnostic and clinical care pathways, where knowledge of 5q31.2 deletion status would be important for clinical management.



This device is designed to detect genomic losses larger than the region covered by the red clone in this probe set, which includes the 5q31.2 region. Genomic losses outside this region or partial losses of this region may not be detected with this device.

This device is not intended for: use as a stand-alone diagnostic, use as a companion diagnostic, prenatal testing, population-based screening, near-patient testing, or self-testing.

This device has not been validated for sample types, disease types, or purposes outside of those stated in the intended purpose.

It 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.

Reporting and interpretation of FISH results should be performed by suitably qualified staff, consistent with professional standards of practice, and should take into consideration other relevant test results, clinical and diagnostic information.

This device is intended for laboratory professional use only.

Failure to adhere to the protocol may affect the performance and lead to false positive/negative results.

What our customers say


  1. Ebert. Best Pract Res Clin Haematol. 2010;23(4):457-461.
  2. WHO Classification of Tumours Editorial Board. Haematolymphoid tumours [Internet; beta version ahead of print]. Lyon (France): International Agency for Research on Cancer; 2022 [cited 2023 September 19]. (WHO classification of tumours series, 5th ed.; vol. 11). Available from:
  3. Joslin, et al. Blood;110(2):719-726.

Recommended protocol for CytoCell haematology FISH

Select a protocol step to view:

Sample and slide preparation

1. Sample & Slide Prep Dark Blue
  • 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.
Haematology FISH protocol Video Image
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Haematology FISH protocol

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