The Role of Flow Cytometry in the Diagnosis of PNH

Screening and diagnosis of patients with PNH has improved with the development of flow cytometry. 1 Immunophenotypic analysis of GPI-linked antigen expression on red cells and peripheral blood granulocytes by flow cytometry provides a rapid, sensitive and specific method for screening and diagnosis of PNH. 2

Traditional laboratory methods for diagnosing PNH are based on proving an increased susceptibility of patient erythrocytesto lysis by complement, activated by acidification ofserum. Though thistype of testing has been modified to improve sensitivity and specificity, flow cytometry is superior as a diagnostic method. Flow cytometry is the gold standard for testing for PNH and is recommended by the International PNH Interest Group. 3

Miraca Life Sciences and the Use of Quality Flow Cytometry

In concert with guidelines from the International Clinical Cytometry Society (ICCS) and the International PNH Interest Group, Miraca Life Sciences provides high sensitivity flow cytometry testing on peripheral blood for the detection of PNH clones. In accordance with the ICCS guidelines, Miraca Life Sciences utilizes informative reagents for flow cytometry, including CD59 and CD235A for red cells and FLAER, CD24, CD16, CD15, CD14, CD33 and CD45 for granulocytes and monocytes. 4

According to Andy Moye, Vice President of Miraca Life Sciences Hematopathology Group,”Miraca Life Sciences offers high sensitivity testing to identify and differentiate blood-based disorders and cancers. In the case of PNH, the ICCS guidelines validate our standard laboratory operations. Our difference is further validated by being recognized as one of the few laboratories able to perform high-sensitivity flow cytometry for PNH patients by Alexion Pharmaceuticals (the developer of eculizumab (Soliris®) a therapeutic monoclonal antibody for the treatment of PNH).”

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2. Richards SJ, Barnett D. The role of flow cytometry in the diagnosis of paroxysmal nocturnal hemoglobinuria in the clinical laboratory. Clin Lab Med. 2007 Sep;27(3):577-90, vii.

3. Parker C, Omine M, Richards S, et al. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood 2005;106(12):3699-4709.

4. 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. Cytometry Part B Clin Cytometry, 2010; 78B:211-230.

5. Brodsky, RA. How I treat paroxysmal nocturnal hemoglobinuria. Blood 2009;113:6522-6527.