Paroxysmal Nocturnal Hemoglobinuria (PNH) by Flow : 1003013

Message
Please submit a copy of the most recent CBC with differential report and any clinical information related to the patient's disease state. The CBC w/diff is needed for the reporting of the flow cytometry interpretative results.


Test Code
MDFCPFPNH or 1003013


Alias/See Also
PI-Linked Antigen


CPT Codes
88184, 88185x7

Instructions
Collect Peripheral blood in a Green Top Sodium Heparin tube (4-10 mL). Lavender Top EDTA tube is acceptable if a Green Top tube is not available. The specimen must be received within 24 hours of collection. Do not centrifuge. Transport at ambient temperature within 24 hours. Specimen can be refrigerated if not transported immediately. Do not freeze. Protect from heat with a refrigerated cold (not frozen) pack.


Transport Container
Blood specimen must be received within 24 hours of collection. Do not centrifuge.


Transport Temperature
Ambient temperature within 24 hours. Specimen should be refrigerated if not transported immediately. Refrigerate after 24 hours. Do not freeze. Protect from heat with a refrigerated cold (not frozen) pack.


Specimen Stability
Ambient: 24 hours; Refrigerated: 48 hours; Frozen: Unacceptable


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Rejected only with Pathologist approval


Methodology
Immunophenotyping by Flow Cytometry

Setup Schedule
Sunday - Saturday


Report Available
1-2 days


Limitations
Laboratory test results should always be considered in the context of clinical observations. This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration
(FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments
of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.



Reference Range
An interpretive report will be provided.


Clinical Significance
This is a diagnostic test for paroxysmal nocturnal hemoglobinuria (PNH), a rare form of hemolytic
anemia characterized by intravascular haemolysis and venous thrombosis. PNH is associated with
immune-mediated bone marrow failure, as well as PNH/aplastic anemia and PNH/myelodysplasia.
This test detects the presence of PNH cells, which lack expression of the X-linked PIGA gene.


Performing Laboratory
med fusion



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.