Ordering Recommendation

Use to quantify or monitor paroxysmal nocturnal hemoglobinuria clone size. Preferred initial diagnostic test is Paroxysmal Nocturnal Hemoglobinuria (PNH), High Sensitivity, RBC and WBC (2005006).


Quantitative Flow Cytometry




1-3 days

New York DOH Approval Status
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
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.


Lavender (EDTA), pink (K2EDTA), or green (sodium or lithium heparin).

Specimen Preparation

Transport 4 mL whole blood. (Min: 4 mL)

Storage/Transport Temperature


Unacceptable Conditions

Bone marrow. Clotted or hemolyzed specimens.


Specimens must be analyzed within stability times provided.


Ambient: 24 hours; Refrigerated: 72 hours; Frozen: Unacceptable

Reference Interval

By report

Interpretive Data

This test was developed according to published guidelines (Cytometry B Clin. Cytom. 2010; 78:211) and as updated in 2014 (Cytometry B Clin. Cytom. 2014; 86:44). WBC analysis is the most accurate measurement of the PNH clone size and uses FLAER and CD157 as GPI-linked markers with CD15 (PMNs) and CD64 (monocytes) as lineage-specific markers. The lower limits of detection are 0.005 percent for PMNs and 0.020 percent for monocytes.

For initial diagnosis of PNH, order High Sensitivity RBC and WBC Panel (ARUP test code 2005006). The presence of a subclinical 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).

For delineation of RBC Types II and III populations when the RBC clone size is greater than 1 percent, order PNH, High Sensitivity, RBC (ARUP test code 2004366).

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.

Hotline History
CPT Codes

86356 x5

Component Test Code* Component Chart Name LOINC
2005004 % PNH Monocytes 60554-3
2005005 % PNH PMN 53831-4
* 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, CD64, CD157, FLAER)
  • Eculizumab treatment monitoring assay
Paroxysmal Nocturnal Hemoglobinuria, High Sensitivity, WBC