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DryFlowEx PNH High-Sensitivity Assay Kit

DryFlowEx PNH High-Sensitivity Assay Kit
Application: Flow cytometry
Target Species: Human
Regulatory Status: CE IVD
Quantity: 25 tests
Order number: ED7750
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What is detected and measured The DryFlowEx PNH High-Sensitivity Assay Kit is intended for... more
Product information "DryFlowEx PNH High-Sensitivity Assay Kit"

What is detected and measured

The DryFlowEx PNH High-Sensitivity Assay Kit is intended for high-sensitivity detection and enumeration of glycosyl-phosphatidylinositol (GPI)-deficient cells in human whole blood by flow cytometry.

This measurement aids in the diagnosis, monitoring, and clinical management of patients with Paroxysmal Nocturnal Haemoglobinuria (PNH), a very rare, but often extremely debilitating, haematopoietic stem cell disorder.

The DryFlowEx PNH High-Sensitivity Assay Kit has been developed according to the current ICCS/ESCCA consensus guidelines [1]to detect Paroxysmal Nocturnal Haemoglobinuria (PNH) clones in erythrocytes, monocytes and neutrophils. It detects and measures relative percentages of:

  • CD59 dim or CD59- cells from all erythrocytes (CD235a+)
  • CD59 dim or CD59- cells from all reticulocytes (CD235a+ CD71+)
  • CD14-, CD157- and GPI anchor- cells from all monocytes (CD45+CD64+)
  • CD24-, CD157- and GPI anchor- cells from all neutrophil granulocytes (CD45+CD15+)

In erythrocytes, it allows discrimination of complete (Type III) and partial (Type II) GPI-deficient erythrocytes for evaluation of the PNH clone size. In addition, it detects GPI-deficient reticulocytes (immature erythrocytes) in patients receiving blood transfusions when PNH erythrocytes are difficult to delineate.

 

[1] Illingworth AJ, Marinov I, Sutherland DR. Sensitive and accurate identification of PNH clones based on ICCS/ESCCA PNH Consensus Guidelines-A summary. Int J Lab Hematol. 2019 May;41 Suppl 1:73-81. doi: 10.1111/ijlh.13011. PMID: 31069981.

Manufacturer: Exbio Praha, a.s.

Trademarks: Cy™ and CyDyes™ are trademarks of Cytiva; Alexa Fluor™ and Pacific Blue™ are trademarks of Life Technologies Corporation.

The Reagents are sufficient for the examination of 25 patient samples

  • 25 pouches, each containing one tube each of
    - PNH WBC single test tube (dried 7-colour panel)
    - PNH RBC single test tube (dried 3-colour panel)
  • 1 set of compensation tubes (7 for WBC tube and 3 for RBC tube
  • 1 bottle of lysing solution (10x formaldehyde-based)

 

Composition of the PNH WBC 7-colour tube

Antigen Fluorochrome Clone Isotype Purpose 
 GPI anchor
(Proaerolysin)
 Alexa Fluor™ 488       GPI-linked (Neutrophils & Monocytes)
 CD157  PE  SY11B5  IgG1  GPI-linked (Neutrophils & Monocytes)
 CD45  PerCP-Cy™5.5   2D1  IgG1  Exclusion of debris, unlysed RBC
 CD64  PE-Cy™7   10.1  IgG1  Gating on Monocytes
 CD24  APC  SN3  IgG1  GPI-linked (Neutrophils)
 CD14  APC-Cy™7   MEM-15  IgG1  GPI-linked (Monocytes)
 CD15  Pacific Blue™   MEM-158  IgM  Gating on Neutrophils

 

Composition of the PNH RBC 3-colour tube

Antigen Fluorochrome Clone Isotype Purpose 
CD235a  FITC   JC159  IgG1  Gating on RBC
CD59  PE MEM-43  IgG2a  GPI-linked for RBC
CD71  APC   MEM-75  IgG1  Gating on reticulocytes
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