XL 20q12/20qter/8cen plus

Deletion Probe

Order Number
D-5122-100-TC
Package Size
100 µl (10 Tests)
Labels
   
Chromosomes
208
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 20q12/20qter/8cen plus probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 8, deletions of the PTPRT gene region at 20q12 and isoderivative chromosomes 20q 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 acute myeloid leukemia (AML), myelodysplastic neoplasms (MDS), myelodysplastic/myeloproliferative neoplasms (MDS/MPN) and myeloproliferative neoplasms (MPN). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.

Product Description

The XL 20q12/20qter/8cen plus probe consists of an aqua-labeled probe hybridizing to the centromere of chromosome 8, an orange-labeled probe hybridizing to the PTPRT gene region at 20q12 and a green-labeled probe hybridizing to a region at 20q13.3.

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Images

XL 20q12/20qter/8cen plus

XL 20q12/20qter/8cen plus hybridized to lymphocytes. One normal interphase is shown.

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Expected Patterns

Expected Pattern 1

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

Expected Pattern 2

Aberrant Cell (typical results):
Two blue (2B), two green (2G), and one orange (1O) signal resulting from the loss of one orange signal.

Expected Pattern 3

Aberrant Cell (typical results):
Three blue (3B), two green (2G) and one orange (1O) signal resulting from loss of one orange signal and a gain of the blue labeled chromosome.

Expected Pattern 4

Aberrant Cell (typical results):
Two blue (2B), three green (3G), and one orange (1O) signal resulting from the presence of ider(20q).

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