XA TriScore (X/Y/21)

Aneusomy Probe

Order Number
D-5603-100-TC
Package Size
100 µl (10 Tests)
Labels
   
Chromosomes
XY21
Regulatory Status
IVDR

IVDR Certification

This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).

MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.

Please use the switch to change to the IVDD product.

IVDDIVDRDiscover all IVDR-certified productsDownload Instructions For Use (IFU)

Until further notice, we will continue to provide IVDD products in various countries.

As part of our phased rollout, the IVDR-certified probes are now available in Australia, Austria, Belgium, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Iceland, Italy, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, New Zealand, Poland, Slovakia, Slovenia, South Africa, and Switzerland, with the list of countries continuously expanding.

Intended Purpose

The XA TriScore (X/Y/21) enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome X, chromosome Y and chromosome 21 by fluorescence in situ hybridization (FISH). The product is intended for prenatal testing of pregnancies at risk for copy number variations of chromosomes X and chromosome Y and trisomy 21 on methanol/acetic-acid fixed uncultured amniocytes.

Product Description

XA TriScore (X/Y/21)

The XA TriScore (X/Y/21) enumeration probe consists of an aqua-labeled probe hybridizing to the centromere of the X-chromosome, a green-labeled probe hybridizing to the centromere of the Y-chromosome and an orange-labeled probe hybridizing to the DSCR4 gene region at 21q22.1-22.2.

Probe maps for selected products have been updated. These updates ensure a consistent presentation of all gaps larger than 10 kb including adjustments to markers, genes, and related elements. This update does not affect the device characteristics or product composition. Please refer to the list to find out which products now include updated probe maps.

Probe map details are based on UCSC Genome Browser GRCh37/hg19, with map components not to scale.

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Images

XA TriScore (X/Y/21)

XA TriScore (X/Y/21) hybridized to lymphocytes. Two aberrant interphases (47,XY,+21) are shown.

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Expected Patterns

Expected Pattern 1

Normal Cell (male):
One green (1G), two orange (2O), and one blue (1B) signal.

Expected Pattern 2

Normal Cell (female):
No green (0G), two orange (2O), and two blue (2B) signals.

Expected Pattern 3

Aberrant Cell (male):
One green (1G), three orange (3O), and one blue (1B) signal.

Expected Pattern 4

Aberrant Cell (female):
No green (0G), three orange (3O), and two blue (2B) signals.

Expected Pattern 5

Aberrant Cell (male):
One green (1G), two orange (2O), and two blue (2B) signals.

Expected Pattern 6

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

Expected Pattern 7

Aberrant Cell (female):
No green (0G), two orange (2O), and one blue (1B) signals.

Expected Pattern 8

Aberrant Cell (female):
No green (0G), two orange (2O), and three blue (3B) signals.

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