Paroxysmal Nocturnal Hemoglobinuria, High Sensitivity, RBC
Also known as: PNH RBC
Use
This test is used to monitor subclinical paroxysmal nocturnal hemoglobinuria (PNH) and eculizumab treatment. It is designed to quantify CD59 expression on erythrocytes using flow cytometry, specifically to identify high-sensitivity PNH RBCs. The test can detect PNH clone size and assist in therapeutic decisions, especially beneficial for evaluating treatment in myelodysplastic bone marrow disorders with subclinical PNH populations. It also helps to accurately measure PNH RBC clone sizes beyond the initial diagnostic contexts.
Special Instructions
Not provided.
Limitations
The test is not FDA-approved and is not suitable for use in New York. The assay results may be affected by recent RBC transfusions, which could decrease the percentage of PNH cells measured. The assay is specifically developed to determine CD59 expression and quantify RBC Type II and III clones when PNH RBCs exceed 1% of the total. It is essential to note that incorrect clinical diagnosis can result from improper sample collection or handling. Clotted or hemolyzed specimens are unacceptable and can result in erroneous results.
Methodology
Cell-based / Cytometry (Flow Cytometry)
Biomarkers
CD235a
AntibodyCD59
Protein
LOINC Codes
- 33662-8 - RBC CD59 deficient NFr
- 93479-4 - Observation Imp
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
4 mL
Minimum Volume
0.5 mL
Container
Lavender (EDTA), pink (K2EDTA), or green (sodium or lithium heparin)
Storage Instructions
Refrigerated
Causes for Rejection
Clotted or hemolyzed specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 4 days |
| Refrigerated | 4 days |
| Frozen | Unacceptable |
Other tests from different labs that may be relevant