XL CDKN2C/
CKS1B

Enumeration Probe

Order Number
D-5099-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
1
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 CDKN2C/CKS1B enumeration probe is a qualitative, non-automated test for the detection of copy number variations of the CDKN2C gene region at 1p32 and the CKS1B gene region at 1q21 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 CDKN2C/CKS1B enumeration probe consists of a green-labeled probe hybridizing to the CDKN2C (p18) gene region at 1p32.3 and an orange-labeled probe hybridizing to the CKS1B gene region at 1q21-22.

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Images

XL CDKN2C/<br />CKS1B

XL CDKN2C/CKS1B hybridized to lymphocytes. Three normal interphases are shown.

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Expected Patterns

Expected Pattern 1

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

Expected Pattern 2

Aberrant Cell (typical results):
Two green (2G) and three orange (3O) signals resulting from gain of one orange signal.

Expected Pattern 3

Aberrant Cell (typical results):
One green (1G) and two orange (2O) signals resulting from loss of one green signal.

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