Paroxysmal Nocturnal Hemoglobinuria (PNH), RBC and WBC
Ordering Recommendation
Preferred test for initial diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) and quantification of PNH clones.
Quantitative Flow Cytometry
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: Only whole blood testing is acceptable. Specimen must be analyzed within 24 hours of collection if ambient or within 48 hours of collection if refrigerated.  
Lavender (EDTA), pink (K2EDTA), or green (sodium or lithium heparin).  
Specimen Preparation
Transport 4 mL whole blood. (Min: 3 mL)  
Storage/Transport Temperature
Unacceptable Conditions
Specimens older than 72 hours. Clotted, Hemolyzed or frozen specimens. Bone marrow specimens.
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.  
Specimens must be analyzed within 72 hours 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.  
Ambient: 24 hours; Refrigerated: 72 hours; Frozen: Unacceptable. New York State Clients: Ambient: 24 hours; Refrigerated: 48 hours. Frozen: Unacceptable  
Reference Interval
By report  
Interpretive Data
This panel is useful in the initial diagnosis of PNH and was developed according to recently published guidelines (Cytometry B Clin Cytom. 2010 Jul; 78(4):211-30); it includes diagnostic WBC analysis and high-sensitivity RBC analysis. WBC analysis is the most accurate measurement of the PNH clone size with a lower limit of detection of 0.1 percent PNH cells and uses FLAER, CD14, and CD24 as GPI-linked markers with CD15 and CD33 as lineage-specific markers. The high sensitivity RBC analysis has a lower limit of detection of 0.005 percent PNH cells and quantifies Type II and Type III RBC populations when the percentage of PNH RBCs is greater than 1 percent. 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).

This test also detects minor (0.005-0.999 percent) PNH clone populations found in bone marrow failure disorders.

Compliance Statement A: Analyte specific reagents (ASR) are used in many laboratory tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration (FDA) approval or clearance. 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, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. This test should not be regarded as investigational or for research use.
CPT Code(s)
86356 x7
Component Test Code*Component Chart NameLOINC
2004367% PNH RBC33662-8
2005004% PNH Monocytes60554-3
2005005% PNH PMN53831-4
* 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.
  • CD15, CD33, CD14, CD24, FLAER, CD59, Glycophorin A
  • PI-Linked Antigens, RBCs, Monocytes and Granulocytes