XL del(5)(q33)

Deletion Probe

Order Number
D-5091-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
5
Regulatory Status
IVDR

IVDR Certification

This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.

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Intended Purpose

The XL del(5)(q33) probe is a qualitative, non-automated test for the detection of deletions of the RPS14 gene region at 5q32-33.1 by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected acute myeloid leukemia (AML) and myelodysplastic neoplasms (MDS). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.

Product Description

The XL del(5)(q33) probe consists of a green-labeled probe hybridizing to a region at 5p15.2-15.3 and an orange-labeled probe hybridizing to the RPS14 locus at 5q32-33.1.

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Images

XL del(5)(q33)

XL del(5)(q33) was hybridized to lymphocytes. One normal interphase and metaphase are shown.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green (2G) and two orange (2O) signals.

Expected Pattern 2

Aberrant Cell (typical results):
Two green (2G) and one orange (1O) signal, indicating the deletion of the RPS14 at 5q33.

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Downloads

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