XA X/Y/18

Aneusomy Probe

Order Number
D-5606-100-TC
Package Size
100 µl (10 Tests)
Labels
   
Chromosomes
XY18
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 X/Y/18 enumeration probe is a qualitative, non-automated test for the detection of copy number variations of chromosome X, chromosome Y and chromosome 18 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 18 on methanol/acetic-acid fixed uncultured amniocytes.

Product Description

The XA X/Y/18 enumeration probe consists of a green-labeled probe hybridizing to the centromere of the X-chromosome, an orange-labeled probe hybridizing to the centromere of the Y-chromosome and an aqua-labeled probe hybridizing to the centromere of the chromosome 18.

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Images

XA X/Y/18

XA X/Y/18 hybridized to normal uncultured amniocytes. A normal signal constellation with 1 orange (Y centromere-specific), 1 green (X centromere-specific) and 2 blue (18 centromere-specific) is observed.

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Expected Patterns

Expected Pattern 1

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

Expected Pattern 2

Normal Cell (female):
Two green (2G) and two blue (2B) signals.

Expected Pattern 3

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

Expected Pattern 4

Aberrant Cell (female):
Two green (2G) and three blue (3B) signals.

Expected Pattern 5

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

Expected Pattern 6

Aberrant Cell (female):
One green (1G) and two blue (2B) signals.

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