Paroxysmal Nocturnal Hemoglobinuria, High Sensitivity, RBC
2004366
Ordering Recommendation
Use to monitor subclinical paroxysmal nocturnal hemoglobinuria and eculizumab treatment. Preferred initial diagnostic test is Paroxysmal Nocturnal Hemoglobinuria Panel, RBC and WBC (2005006).
Mnemonic
PNH RBC
Methodology
Quantitative Flow Cytometry
Performed
Sun-Sat
Reported
1-4 days  
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
New York State Clients: Testing is only approved for the Paroxysmal Nocturnal Hemoglobinuria Panel (ARUP test code 2005006) on whole blood specimens.  
Collect
Lavender (EDTA), pink (K2EDTA), or green (sodium or lithium heparin).  
Specimen Preparation
Transport 4 mL whole blood. (Min: 0.5 mL)  
Storage/Transport Temperature
Refrigerated.  
Unacceptable Conditions
Clotted, hemolyzed, or frozen specimens. Bone marrow specimens.  Specimens older than 4 days.
New York State Clients: Specimens for the PNH PAN older than 24 hours ambient or older than 48 hours refrigerated. Clotted, hemolyzed or frozen specimens.  Bone marrow specimens.  
Remarks
Specimens must be analyzed within 4 days of collection.
New York State Clients: Only the whole blood PNH PAN is acceptable and must be analyzed within 24 hours of collection if ambient or 48 hours of collection if refrigerated.  
Stability
Ambient: 4 days; Refrigerated: 4 days; Frozen: Unacceptable
New York State Clients: PNH PAN-Ambient: 24 hours; Refrigerated: 48 hours. Frozen: Unacceptable  
Reference Interval
By report   
Interpretive Data
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 (0.005 percent-0.999 percent) PNH population 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 and distinguishes between Type II and Type III cells when the PNH cell percentage is 1 percent or greater. Glycophorin A is used to gate the RBC population. CD59 is the GPI-linked antigen. Recent RBC transfusions may decrease the percentage of PNH cells. (Cytometry 42:223-33, 2000).

For the most accurate measurement of the PNH clone size, the PNH WBC (ARUP test code 2005003) is available to assist with therapeutic decisions in conventional PNH.

For initial diagnosis of PNH and analysis of both RBCs and WBCs, Paroxysmal Nocturnal Hemoglobinuria Panel, RBC and WBC (ARUP test code 2005006) is available.

See Compliance Statement A: www.aruplab.com/CS  
Note
 
CPT Code(s)
86356 x2
Components
Component Test Code*Component Chart Name
2004367% PNH RBC
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • CD15, CD33, CD14, CD24, FLAER
  • PI-Linked Antigens on RBCs