High Sensitivity PNH Evaluation
Use
This high-sensitivity evaluation of Paroxysmal Nocturnal Hemoglobinuria (PNH) uses flow cytometry to detect red blood cell and granulocyte PNH clones at extremely low frequencies (down to 0.01%), providing highly sensitive diagnostic capability for identifying PNH even in patients with very small clone burdens. It supports accurate detection of PNH clones to guide diagnosis and clinical decision-making in relevant hematologic conditions.
Special Instructions
Level of Service options include Global and Tech Only. For New York clients, additional requirements include Date and Time of Collection and recent transfusion history. A recent CBC report is requested. The assay is New York State–approved, and sample handling must meet state-specific transport requirements.
Limitations
Bone marrow specimens are not acceptable. Lithium heparin or ACD tubes are not acceptable; only EDTA is preferred (sodium heparin acceptable). Specimens must be received within 48 hours to assure integrity and viability. Samples must be refrigerated and never frozen; cold packs should not contact specimens directly.
New York Approved
Methodology
Cell-based / Cytometry (Flow Cytometry)
Biomarkers
Result Turnaround Time
24 hours
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
1-2 mL
Minimum Volume
Not provided
Container
EDTA tube preferred; sodium heparin acceptable; lithium heparin or ACD not acceptable
Collection Instructions
Provide a recent CBC report; bone marrow specimens not acceptable
Storage Instructions
Refrigerate specimen; do not freeze; use cold pack for transport (not in direct contact with specimen)
Causes for Rejection
Lithium heparin or ACD tubes; bone marrow specimens; samples received after 48 hours; frozen samples
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | Within 48 hours accepted |