Use to monitor subclinical paroxysmal nocturnal hemoglobinuria and eculizumab treatment. Preferred initial diagnostic test is Paroxysmal Nocturnal Hemoglobinuria (PNH), High Sensitivity, RBC and WBC (2005006).
Quantitative Flow Cytometry
New York State Clients: Testing is only approved for the Paroxysmal Nocturnal Hemoglobinuria (PNH), High Sensitivity, RBC and WBC (ARUP test code 2005006) on whole blood specimens.
Lavender (EDTA), pink (K2EDTA), or green (sodium or lithium heparin).
Transport 4 mL whole blood. (Min: 0.5 mL)
Bone marrow. Clotted or hemolyzed specimens.
Specimens must be analyzed within stability times provided.
Ambient: 4 days; Refrigerated: 4 days; Frozen: Unacceptable
This assay tests for CD59 on erythrocytes using flow cytometry. The percentage of red blood cells (RBCs) with normal expression of CD59 is decreased in paroxysmal nocturnal hemoglobinuria (PNH). The presence of a subclinical PNH population (0.005-1.000 percent) in myelodysplastic bone marrow disorders, such as aplastic anemia or refractory anemia, may correlate with a positive immunotherapeutic response (Blood 2006; 107, 1308-1314).
The lower limit of detection of this test is 0.005 percent PNH cells. This test will distinguish between Type II and Type III cells when the PNH cell percentage is 1 percent or greater. Glycophorin A (CD235a) is used to gate the RBC population. CD59 is the GPI-linked antigen. Recent RBC transfusions may decrease the percentage of PNH cells measured in RBCs (Cytometry 2000; 42:223-33).
For the most accurate measurement of the PNH clone size, order Paroxysmal Nocturnal Hemoglobinuria, High Sensitivity, WBC (ARUP test code 2005003) to assist with therapeutic decisions in conventional PNH.
For initial diagnosis of PNH and analysis of both RBCs and WBCs, order Paroxysmal Nocturnal Hemoglobinuria (PNH), High Sensitivity, RBC and WBC (ARUP test code 2005006).
Compliance Statement A: For laboratory developed tests using a manufacturer labeled ASR as the reagent providing the specificity of the assay. Analyte Specific Reagent. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, the FDA has determined that such clearance or approval is not necessary.
|Component Test Code*||Component Chart Name||LOINC|
|2004367||% PNH RBC||33662-8|
- 59 and Glycophorin A
- PI-Linked Antigens on RBCs