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Reentry for Donors Deferred Based on Anti-HBc Test Results

Reentry for Donors Deferred Based on Anti-HBc Test Results. November 3, 2005 BPAC Meeting FDA/CBER/OBRR/DETTD. Issue.

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Reentry for Donors Deferred Based on Anti-HBc Test Results

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  1. Reentry for Donors DeferredBased on Anti-HBc Test Results November 3, 2005 BPAC Meeting FDA/CBER/OBRR/DETTD

  2. Issue FDA would like to update the Committee on a proposed algorithm that would allow reentry of donors deferred for testing repeatedly reactive (RR) for antibodies to hepatitis B core antigen (anti-HBc) on more than one occasion.

  3. Donor Screening for Anti-HBc: September 10, 1991 Guidance • Donations for transfusion should be tested for anti-HBc. Only negative units should be transfused. • Donors should be indefinitely deferred when they test RR more than once. • Donor reentry algorithm not recommended at that time because there was no supplemental (additional, more specific) tests for anti-HBc.

  4. Consequences of anti-HBc screening Although anti-HBc donor screening has contributed to blood safety, many donors have been indefinitely deferred because of potentially false positive (FP) anti-HBc results.

  5. Considerations • Reentry permitted only on the premise that i) historical tests for anti-HBc were false positives and ii) there is no evidence for past or present hepatitis B virus infection.

  6. December 1998 BPAC Meeting • FDA and AABB presented to BPAC similar reentry algorithms based on negative test results for HBsAg, anti-HBc, anti-HBs. • The Committee did not recommend reentry because ARC data showed that some HBsAg and anti-HBc negative samples were HBV DNA reactive using an experimental NAT.

  7. October 2004 BPAC Meeting • FDA presented to BPAC the following reentry algorithm based on negative test results for HBsAg, anti-HBc, and HBV NAT. • The Committee did not vote on the proposed re-entry algorithm because of lack of data to validate its use.

  8. Proposed Anti-HBc Re-entry algorithm A donor who has been indefinitely deferred because of having tested repeatedly reactive for anti-HBc on more than one occasion may be reentered if,

  9. Proposed Anti-HBc Re-entry algorithm a) after a minimum of 8 weeks subsequent to the last repeatedly reactive anti-HBc test, a new sample is collected from the donor, and this sample tests negative for HBsAg, anti-HBc, and HBV NAT (sensitivity of 95% detection at <10 copies/mL) in FDA licensed assays. and

  10. Proposed Anti-HBc Re-entry algorithm b) when a donor presents at a blood center to donate, subsequent to the negative tests for HBsAg, anti-HBc and HBV NAT, all donor suitability criteria for donors of Whole Blood and components are fulfilled.

  11. Recent Developments • FDA licensed in April 2005 the Roche Cobas AmpliScreenHBV NAT for screening donations in minipool and individual donation (ID) format. Roche presented data showing that its is possible to enhance the sensitivity of the ID test.

  12. Recent Developments • FDA licensed in October 2005 the Abbott PRISM anti-HBc test for screening donations. This test uses different technology than other currently licensed assays and could be used in the re-entry algorithm.

  13. Request for Data • The FDA is looking forward to reviewing data to validate the proposed reentry algorithm for anti-HBc repeat reactive donors

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