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Test Name:
Paroxysmal Nocturnal Hemoglobinuria, by Flow Cytometry

• SBMF No:
  36161
• Performance Lab Name:
  Flow Cytometry/Molecular Pathology
• Test Mnemonic:
  PNH PANEL
• ABN:
  Required – Not FDA-Approved
• CPT Code:
  88184; 88185x3; 88187
• LOINC Code:
  21026-0; 49031-8; 17126-4; 53831-4; 53831-4
• Also Known As:
  Flow Cytometry Test for PNH
  PI-Linked Antigen
• Spec Type:
  Whole blood
• Spec Container:
  Lavender top (EDTA) tube
• Pref Vol:
  5.0 mL
• Min Vol:
  2.5 mL
• Fasting:
  No
• Spec Collect:
  Collect Monday through Thursday only and not the day before a holiday
  Routine venipuncture
• Spec Process:
  Do not centrifuge
  Do not remove plasma from cells
• Spec Store Transport:
  Refrigerated
• Spec Stability:
  24 hours room temperature (20-30°C)
  48 hours refrigerated (2-8°C)
  Frozen (-20°C): Unacceptable
• Spec Reject:
  Sample received in testing department greater than 48 hours after collection
• Spec Remarks:
  TIME SENSITIVE – Sample must be received by SBMF Flow Cytometry Department within 48 hours of collection
• Methodology:
  Flow Cytometry
• Use:
  Screening for or confirming a diagnosis of PNH. Evaluation of patients with hemolytic anemia or pancytopenia of undetermined cause.
• Clinical Significance:
  Paroxysmal Nocturnal Hemoglobinuria (PNH) is an uncommon acquired hematologic disorder characterized by nocturnal hemoglobinuria, chronic hemolytic anemia with acute episodes, pancytopenia, thrombosis and, in some patients, acute or chronic myeloid malignancies. It is a disorder of hematopoietic stem cells and affects erythroid, myeloid and megakaryocytic cell lines. It is caused by mutations in the phosphatidylinositol glycan A (PIG-A) gene of the stem cell. This results in disruption of the synthesis of GPI and a deficiency in all GPI-anchored proteins in the affected cells. A consequential absence of the GPI linked complement inhibitors CD55 and CD59 causes the blood cells to be susceptible to complement mediated hemolysis.
• Reference Range:
  

  % RBC CD59 PNH     % FLAER/CD24 PNH      % FLAER/CD59 PNH GRAN

  0-1    0-1    0-1

  % % %

  Reference Information:
  The partial or complete absence of at least 1 GPI-linked antigen in 2 or more different lineages is indicative of PNH. A PNH clone size of more than 1% for RBCs and/or more than 10% for granulocytes indicates classic PNH. Smaller clone sizes suggest hypoplastic PNH.

  Reports include interpretation by pathologist

• Additional Test Info:
  This test was developed and it performance was established and confirmed by the South Bend Medical Foundation (SBMF). This test is not cleared or approved by the U.S. FDA. This test is used for clinical purposes and should not be regarded as investigational or for research. SBMF is authorized under Clinical Laboratory Improvement Amendments(CLIA) to perform high-complexity testing.
• Test Type:
  FLOW