Home Probes XL XL 5p15/9q22/15q22 Hyperdiploidy

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.

Please use the switch to change to the IVDD product.

IVDDIVDRDiscover all IVDR-certified products

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.

Need assistance or a quote?

Images

XL 5p15/9q22/15q22 Hyperdiploidy

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

Need assistance or a quote?

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.

Need assistance or a quote?

Downloads

Performance Data (English)Probes Catalog

Certificate of Analysis (CoA)

or go to CoA Database

News

IVDR Certification

MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.

IVDR Certification