A colleague in Buenos Aires asks how others manage re-entry of repeat blood donors who after many blood donations demonstrate a single reactive test for anti-HBc, but who test non-reactive for anti-HBs. The donor in question denies any risk behaviors for hepatitis B infection. A brief test history of the donor is shown below:

• 6/14/02: anti-HBc Non-Reactive (Biokit test from Spain)
• 12/06/02: anti-HBc Reactive, Gray zone (Biokit test from Spain); s/co: 0.680/0.706; anti-HBs non-reactive
• 3/06/03: anti-HBc Non-Reactive (Biokit test from Spain); s/co 0.722/0.626
• 8/09/04: anti-HBc Non Reactive (Axsym Abbott); s/co: 1.395

The following responses have been received.

1. A colleague at a blood center in California reported that per an FDA memorandum issued in September 1991, if a donor is repeatedly reactive for anti-HBc on two occasions (either two different samples or two different manufacturer's tests on one sample) they will not re-enter the donor due to the lack of confirmatory testing. Therefore, in this case under discussion, provided the donor has no other reason for deferral, the donor could be re-entered.

2. A colleague on the East coast comments that for the specific donor referenced in this discussion, he will assume that all donations are HBsAg non-reactive, that all other disease markers are negative or within normal limits, and that the donor has no history or physical findings that would cause disqualification. Based on his understanding of the above FDA memorandum, on a first anti-HBc repeat reactive donation, donated red cells and platelets are to be discarded but the plasma can be diverted to fractionation. The donor is put in a surveillance category for one-time anti-HBC repeat reactive; the individual is not deferred. If subsequent donations are non-reactive for anti-HBc, all components may be used. If a subsequent donation is repeated reactive for anti-HBC (i.e., the second time), donated red cells and platelets are to be discarded but the plasma can be diverted to fractionation, however, the donor is now deferred. The number of intervening non-reactive donations between the two repeat reactive for anti-HBc is irrelevant.

ADDENDA May 23, 2008

3. The Editors believe that the following Draft Guidance for Industry "Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)" is germane to this discussion.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator