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22958 PNH-Paroxysmal Nocturnal Hemoglobinuria

PNH-Paroxysmal Nocturnal Hemoglobinuria
Test Code: PNH-FC
Synonyms/Keywords
Flow Cytometry, CD55, CD59, Ham's Test for PNH, Sucrose Hemolysis Test​
Useful For
Paroxysmal Nocturnal Hemoglobinuria (PNH) is an acquired clonal disorder of hematopoiesis characterized by an unusual sensitivity of the abnormal RBC’s to complement lysis leading to intravascular hemolysis.  PNH is characterized by a triad of intravascular hemolysis, cytopenias secondary to underlying bone marrow failure, and a predisposition to venous thrombosis.  PNH is a chronic condition with a median survival of between 10 and 15 years.  The most common causes of morbidity and mortality are venous thrombosis, particularly affecting the hepatic veins, and progressive bone marrow failure.​
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
No​ Whole blood​ EDTA Lavender Top Tube (LTT)
EDTA Pink Top Tube (PTT)​		 ​ 1 mL​ 1 mL​ 0.5 mL​
Collection Processing Instructions
Contact Flow Cytometry (800-222-5835, ext. 16385) prior to specimen collection to discuss additional specimen requirements (unstained slide, a normal control specimen and patient history).
Specimen Stability Information
Specimen Type Temperature Time
Whole blood​ Refrigerated​ 5 days​
Rejection Criteria
Fixed specimens
Frozen​
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Marshfield​ Monday through Friday, days only​ 3 days​ Flow Cytometry​
Test Information
This test replaces the Ham's and the Sucrose Hemolysis tests for detection of PNH.
 
This test was developed and its performance characteristics determined by Marshfield Labs.  It has not been cleared or approved by the U.S. Food and Drug Administration.  The FDA has determined that such clearance or approval is not necessary.  This test is for clinical purposes.  It should not be regarded as investigational or for research.  This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing.
 
Monoclonal antibodies tested include: CD59 on red blood cells, CD14, CD33, and FLAER on monocytes and granulocytes.
Reference Range Information
Performing Location Reference Range
Marshfield​ Interpretive report​
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
88184​ ​ 1​ Technical first marker​ ​
88185​ ​ 3 Technical additional markers​ ​
88187​ ​ ​ Interpretation​ ​
Classification
This test was developed and its performance characteristics determined by Marshfield Labs.  It has not been cleared or approved by the U.S. Food and Drug Administration.  The FDA has determined that such clearance or approval is not necessary.  This test is for clinical purposes.  It should not be regarded as investigational or for research.  This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing.
Synonyms/Keywords
Flow Cytometry, CD55, CD59, Ham's Test for PNH, Sucrose Hemolysis Test​
Ordering Applications
Ordering Application Description
​Centricity ​PNH
​Cerner ​Pnh-Paroxysmal Nocturnal Hemoglobinuria
​COM ​PNH
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
No​ Whole blood​ EDTA Lavender Top Tube (LTT)
EDTA Pink Top Tube (PTT)​		 ​ 1 mL​ 1 mL​ 0.5 mL​
Collection Processing
Contact Flow Cytometry (800-222-5835, ext. 16385) prior to specimen collection to discuss additional specimen requirements (unstained slide, a normal control specimen and patient history).
Specimen Stability Information
Specimen Type Temperature Time
Whole blood​ Refrigerated​ 5 days​
Rejection Criteria
Fixed specimens
Frozen​
Useful For
Paroxysmal Nocturnal Hemoglobinuria (PNH) is an acquired clonal disorder of hematopoiesis characterized by an unusual sensitivity of the abnormal RBC’s to complement lysis leading to intravascular hemolysis.  PNH is characterized by a triad of intravascular hemolysis, cytopenias secondary to underlying bone marrow failure, and a predisposition to venous thrombosis.  PNH is a chronic condition with a median survival of between 10 and 15 years.  The most common causes of morbidity and mortality are venous thrombosis, particularly affecting the hepatic veins, and progressive bone marrow failure.​
Reference Range Information
Performing Location Reference Range
Marshfield​ Interpretive report​
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Marshfield​ Monday through Friday, days only​ 3 days​ Flow Cytometry​
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
88184​ ​ 1​ Technical first marker​ ​
88185​ ​ 3 Technical additional markers​ ​
88187​ ​ ​ Interpretation​ ​
Classification
This test was developed and its performance characteristics determined by Marshfield Labs.  It has not been cleared or approved by the U.S. Food and Drug Administration.  The FDA has determined that such clearance or approval is not necessary.  This test is for clinical purposes.  It should not be regarded as investigational or for research.  This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing.
For most current information refer to the Marshfield Laboratory online reference manual.