The AABB in conjunction with the American Red Cross and America’s Blood Centers issued a joint statement last week before the Food and Drug Administration’s (FDA) Blood Products Advisory Committee (BPAC) about molecular blood typing assays, such as the Immucor PreciseType Human Erythrocyte Antigen Molecular BeadChip assay.
Molecular assays for blood products have been in use for a number of years and have improved the safety of the blood supply, especially for those patients undergoing chronic transfusions and those with alloantibodies. The workgroup stressed the following in general to molecular typing assays. Lab developed tests and research use only assays are acceptable for use while similar assays are being licensed. Furthermore, the results from a licensed molecular phenotype test do not need to be confirmed with an alternate assay. Finally, licensed molecular assays need to be clearly labeled on limitations including the frequency of discrepancies between molecular and serological test results. The BPAC recommend approval to the FDA that the Immucor assay be accepted for clinical use.
AABB Statement. A Joint Statement Presented Before the Food and Drug Administration’s Blood Products Advisory Committee. March 18, 2014. Accessed online: http://www.aabb.org/pressroom/statements/Pages/statement140318.aspx.