Paroxysmal Nocturnal Hemoglobinuria (PNH) by FLAER (High Sensitivity)

Test ID: FLOW PNH CPT Code: 88184, 88185x6, 88187

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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.

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

Oncology Pathology Requisition

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)

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