The 20q12 probe, labelled in red, covers a 331kb region within the PTPRT gene and includes the D20S108 marker. The 20q13.1 probes, labelled in green (141kb and 174kb), cover the MYBL2 gene and includes the D20S150 marker.
Deletions of the long arm of chromosome 20 are recognised as recurrent chromosomal abnormalities associated with myelodysplastic syndromes (MDS). The prognosis for MDS where del(20q) is the sole abnormality is good; however, the presence of secondary abnormalities may be indicative of disease progression1.
Microscope image
The CytoCell® Del(20q) Deletion Probe is a qualitative, non-automated, fluorescence in situ hybridisation (FISH) test used to detect chromosomal deletions in the 20q12 and 20q13.1 regions on chromosome 20 in Carnoy’s solution (3:1 methanol/acetic acid) fixed haematologically-derived cell suspensions from patients with confirmed or suspected myelodysplastic syndrome (MDS).
This device is designed as an adjunct to other clinical and histopathological tests in recognised diagnostic and clinical care pathways, where knowledge of 20q12 or 20q13.1 deletion status would be important for clinical management.
This device is designed to detect genomic losses larger than the regions covered by the red and green clones in this probe set, which includes the 20q12 and 20q13.1 regions. Genomic losses outside this region or partial losses of this region may not be detected with this product.
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.
The quality of the products we have received from CytoCell have been excellent. The FISH probes they provide to us give intense, strong signals and are a pleasure to count. What has really stood out however has been the level of support and assistance provided by CytoCell’s application specialists. The team worked very closely alongside our own during the adoption of this product and spent many hours with us perfecting the technique, going above and beyond what I would expect during the transition period. Source BioScience absolutely demand high quality products and service to be able to deliver our results with confidence, and that is what we have received from CytoCell.
Neil Ryan
Laboratory Operations Manager, Source BioScience, UK
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