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FDA Approves HEA Test for Sickle Cell Trait

December 30, 2021

The FDA approved a new molecular assay (PreciseType Human Erythrocyte Antigen [HEA] test) to screen for sickle cell trait (SCT) in blood donors. The test was previously approved by the FDA for use in determining blood compatibility between donors and transfusion recipients. Screening for SCT helps to avoid the transfer of SCT-positive red blood cells to neonates or patients with sickle cell disease. Blood from SCT donors also can cause complications when performing the required filtration of white cells from the blood donation. The new HEA test allows these units to be identified prior to filtration.

Source: Immucor press release, October 26, 2016.

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