DryFlowEx PNH High-Sensitivity Assay Kit
Application: | Flow cytometry |
Target Species: | Human |
Regulatory Status: | CE IVD |
Quantity: | 25 tests |
Order number: | ED7750 |
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
- 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 |