XA 13/18/21

Aneusomy Probe

Order Number
D-5607-100-TC
Package Size
100 µl (10 Tests)
Labels
   
Chromosomes
131821
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 XA 13/18/21 enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 13, chromosome 18 and chromosome 21 by fluorescence in situ hybridization (FISH). The product is intended for prenatal testing of pregnancies at risk for trisomy 13, trisomy 18 and trisomy 21 on methanol/acetic-acid fixed uncultured amniocytes.

Product Description

The XA 13/18/21 enumeration probe consists of a green-labeled probe hybridizing to the RB1 gene region at 13q14.2, an aqua-labeled probe hybridizing to the MALT1 gene region at 18q21.3 and an orange-labeled probe hybridizing to the DSCR4 gene region at 21q22.1-22.2.

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Images

XA 13/18/21

XA 13/18/21 hybridized to cultured amniocytes. A normal signal constellation is observed for 13q14 and 21q22, two green and two orange signals, respectively. For the 18q21 locus-specific probe three blue signals 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 orange (2O), and two blue (2B) signals.

Expected Pattern 3

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

Expected Pattern 4

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

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News

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