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

Composition of the PNH RBC 3-colour tube