This test can be used to confirm the suspected diagnosis of Hereditary Spherocytosis (HS). HS is a common inherited hemolytic anemia characterized by the presence of spherical erythrocytes (spherocytes). HS can be diagnosed based on family history and clinical features, along with clinical laboratory tests including peripheral smear examination, osmotic fragility (OF), ektacytometry or flow cytometry. Band 3 is the most abundant transmembrane protein found in the human RBC. Eosin-5-maleimide (EMA) dye binds to band 3 on intact RBCs and a reduction of fluorescence intensity is seen in hereditary spherocytosis. This test by flow cytometry has been reported to have a sensitivity of 93 percent for diagnosis of HS. Congenital Dyserythropoietic Anemia Type II, Southeast Asian Ovalocytosis and Hereditary Pyropoikilocytosis are rare disorders that may have a positive result in this test.
Compliance Statement B
: This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.