XL 5p15/9q22/15q22 Hyperdiploidy

Enumeration Probe

Order Number
D-5095-100-TC
Package Size
100 µl (10 Tests)
Labels
   
Chromosomes
9155
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 5p15/9q22/15q22 Hyperdiploidy enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosomes 5, 9 and 15 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 multiple myeloma (MM). Hybridization is to be performed on methanol/acetic-acid fixed plasma cells.

Product Description

The XL 5p15/9q22/15q22 Hyperdiploidy enumeration probe consists of a green-labeled probe hybridizing to a region at 5p15.2-15.3, an aqua-labeled probe hybridizing to a region at 9q22.3-31 and an orange-labeled probe hybridizing to the SMAD6 gene region at 15q22.3.

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Images

XL 5p15/9q22/15q22 Hyperdiploidy

XL 5p15/9q22/15q22 hybridized to lymphocytes. Two normal interphases are shown.

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Expected Patterns

Expected Pattern 1

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

Expected Pattern 2

Aberrant Cell:
Three green (3G), two blue (2B) and three orange (3O) signals, indicating hyperdiploidy.

Expected Pattern 3

Aberrant Cell:
Three orange (3O), two green (2G) and three blue (3B) signals, indicating hyperdiploidy.

Expected Pattern 4

Aberrant Cell:
Three green (3G), three blue (3B) and two orange (2O) signals, indicating hyperdiploidy.

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