Dear FDA Dockets Manager:
AABB is an international association dedicated to advancing transfusion and cellular therapies worldwide. Our members include more than 1,800 hospital and community blood centers and transfusion and transplantation services as well as approximately 8,000 individuals involved in activities related to transfusion, cellular therapies and transplantation medicine. For over 50 years, AABB has established voluntary standards for, and accredited institutions involved in, these activities. AABB is focused on improving health through the advancement of science and the practice of transfusion medicine and related biological therapies, and developing and delivering programs and services to optimize patient and donor care and safety.
We appreciate the opportunity to provide comments to this draft guidance document. For several years the blood community has worked with FDA to provide data in support of a requalification method for reentry of blood donors who were deferred due to reactive test results for antibody to hepatitis B core antigen. The availability of a reentry mechanism is welcomed by our member facilities and the donors who have waited a long time for an opportunity to once again donate blood.
For purposes of reentry the agency recommends that a licensed HBV NAT labeled as having a sensitivity of </= 10 copies/mL (at 95% detection rate) be used. We do not disagree with the recommendation; however, the language in at least one manufacturers package insert does not appear to be consistent with this recommendation, even though the draft guidance states that this sensitivity reflects the current technological capabilities regarding sensitivity of HBV NAT assays.
The current residual risk of post-transfusion HBV infection from donations screened for HBsAg and anti-HBc has been established as 1:205,000 (Dodd RY, Notari EP, Stramer SL. Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion 2002;42:975-979).
There is an additional reference that we recommend for inclusion in the guidance document. Katz et al. present data that support the feasibility and safety of a reentry method for donors deferred by false positive anti-HBc tests. (Katz L, Strong DM, Tegtmeier G, et al. Performance of an algorithm for the reentry of volunteer blood donors deferred due to false positive test results for antibody to hepatitis B core antigen. Transfusion [manuscript accepted, publication pending]).
AABB strongly supports initiatives that improve the safety of patients and donors, and the adequacy of the blood supply, and stands ready to interact with FDA as necessary.
Please contact me at firstname.lastname@example.org with any questions.
M. Allene Carr-Greer, MT(ASCP)SBB
Director, Regulatory Affairs