Flow Cytometry — Using Peripheral Blood — Is the Gold Standard Diagnostic Test for PNH

Flow cytometry: the most sensitive, informative assay for PNH diagnosis

Detection of PNH clones by flow cytometry, the gold standard diagnostic test for PNH, provides the most consistent and sensitive method of testing for PNH. The Clinical Cytometry Society (CCS) has published guidelines to support the accurate identification and monitoring of PNH cell populations.1

Overview of sample processing in flow cytometry1

  • Send peripheral blood samples to a lab that can perform high-sensitivity testing, in order to detect cell populations numbering as few as 0.01%
  • Stain cells with monoclonal antibodies against GPI-anchored proteins or markers for GPI anchor in both red blood cells (RBCs) and white blood cells (WBCs) that are specific for each cell lineage tested
    • Both RBCs and WBCs should be tested for the presence of PNH clones
    • Multiple markers should be used for each lineage tested, as recommended in the CCS guidelines
  • Ensure that appropriate numbers of gated cells are used for routine analysis and high-sensitivity flow cytometry
  • Report flow cytometric data by describing populations of both RBCs and WBCs that are abnormal or deficient in GPI anchors

In this section:

Flow Cytometry Strategies

  • Test methodology
  • Cell lineage gating

Peripheral Blood Cell Analyses

  • Erythrocyte testing
  • Granulocyte testing
  • Monocyte testing

Reagents for Flow Cytometry

  • High-sensitivity flow cytometry
  • PNH cell reporting

High-Sensitivity Labs

  • Looking for a lab to send flow cytometry samples to? View a listing of labs here.




IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Soliris increases the risk of meningococcal infections. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early

  • Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of Soliris; revaccinate according to current medical guidelines for vaccine use
  • Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary

The effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. Therefore, treatment with Soliris should not alter anticoagulant management.

The most frequent adverse events observed in clinical studies were headache, nasopharyngitis, back pain, nausea, and fatigue.

SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING INCLUDING WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS.


References: 1. Borowitz MJ, Craig FE, DiGiuseppe JA, et al; for Clinical Cytometry Society. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry [published online ahead of print April 28, 2010]. Cytometry Part B Clin Cytometry. doi:10.1002/cyto.b.20525. 2. Parker C, Omine M, Richards S, et al; for International PNH Interest Group. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005;106:3699-3709.