Federal Register Notice: FDA has scheduled a public workshop, "Molecular Methods in Immunohematology" 9/25-26 to gather and review current information on scientific developments that might enhance immunohematologic testing of blood donor or patient blood samples during pre-transfusion compatibility testing, or when determining and managing feto-maternal blood group incompatibilities.

The workshop’s main goal is to determine potential applications of molecular methods to improve safety in transfusion medicine. The agency hopes to do this by overcoming current limitations in the field of immunohematology, namely, the lack of reagent grade antibodies, both polyclonal and monoclonal; variability of reactivity of monoclonal antibodies as compared to polyclonal antibodies; and inherent limitations in the hemagglutination test. Topics slated for discussion include: (1) Use of molecular methods in platelet and leukocyte typing, (2) use of phage display technology in place of routine hemagglutination tests, (3) potential advantages of using molecular methods in donor screening and patient typing, (4) use of molecular methods to resolve unusual serologic findings, (5) potential use of molecular methods in manufacturing immunohematology reagents, and (6) current limitations in the use of molecular methods.

The workshop will be held on 9/25, from 8:30 a.m. to 5 p.m., and 9/26, from 8:30 a.m. to 2 p.m. at the Lister Hill Center Auditorium, Bldg. 38A, National Institutes of Health, 8800 Rockville Pike, Bethesda, MD 20894. Contact Rhonda Dawson, (301) 827-6129. To view this notice, click here.