Paroxysmal Nocturnal Hemoglobinuria (PNH) by FLAER (High Sensitivity)
Expected Turnaround Time
1 day
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Clinical Information
Paroxysmal Nocturnal Hemoglobinuria (PNH) is a high sensitivity flow cytometry test that uses fluorescence labeled proaerolysin (FLAER) to diagnose PNH by identifying abnormal red blood cell populations that lack certain surface proteins, such as CD55 and CD59, due to a genetic mutation. This test may also be used to diagnose glucose phosphate isomerase (GPI) deficiency.
Requisition Forms
Specimen Requirements
Specimen Requirements
Whole Blood: 4 mL (minimum of 0.5 mL with 107 cells), NaHep preferred (EDTA accepted)
Specimen Stability
Specimen stable for 48 hours at 4°C.
Storage Requirements
2°C to 8°C
Shipping Conditions
Refrigerated
Shipping Recommendations
REFRIGERATED, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen
Specimen Rejection Criteria
Specimens stored at incorrect temperature; Non-viable specimens; Specimens in inappropriate anticoagulant; Too few cells; Hemolysis; Specimen clotted
Test Details
Synonyms
PNH Screen, high sensitivity analysis for PNH, CD59, FLAER, GPI deficiency
Keywords
Flow Cytometry, Leukemia, Oncology, Paroxysmal Nocturnal Hemoglobinuria (PNH)
Test Method
Flow cytometry
Methodology Category
Flow Cytometry
Regulatory Status
ASR
Associations
Coombs negative hemolytic anemia, myelodyspastic syndromes with unilineage dysplasia and unexplained hemoglobinuria, aplastic anemia, cytopenia or thrombosis; Soliris® (Eculizumab)