Selective Chagas Testing

Some donor collection centers in the United States have began 'selective Chagas testing'. At least one center reports that they previously were testing 100% of their collections for evidence of Chagas, but currently they are only testing all first time donors and any donors within their database who have never been tested. In light of the recently published Draft Guidance for Industry, "Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)", will other centers also be implementing selective Chagas testing?

The following comments have been submitted in response.

ADDENDA May 14, 2009

1. Dr. Jim AuBuchon, President and CEO of the Puget Sound Blood Center (attribution used with permission) reports that his center is currently employing a 'geographic filter' to determine on which donors Chagas testing is performed. Thus, that center currently is not testing every donor for evidence of T. cruzi infection. However, Dr. AuBuchon anticipates that the FDA will ultimately require a different testing strategy than what his center is currently doing. In his opinion, the future testing strategy might be a "one-time selective testing strategy". Regardless, he says that his center is prepared to implement an FDA required approach.
   
   
2. According to Dr. Richard Benjamin, Chief Medical Officer of the American Red Cross (attribution used with permission), on April 1, 2009, the FDA Blood Product Advisory Committee voted 12 in favor, 5 opposed to a selective testing approach for anti-T. cruzi blood donation screening in which a donor would be qualified for no further testing based on a single lifetime nonreactive test result using an FDA-licensed test system (e.g., the Ortho Chagas ELISA). The committee's decision was contingent on a commitment made by the American Red Cross (ARC) and Blood Systems Inc (BSI) to develop and execute a study to further define the incidence of T. cruzi infection in the US donor population. Dr. Benjamin adds that in the near future, ARC and BSI will be meeting with the FDA and AABB TTD Committee Chagas' disease working group to further define the nature of the incidence study and to better understand the FDA's approach to selective testing. Decisions regarding the nature of selective testing will be made contingent on those discussions.

3. A medical director of a blood donor collection center in Southern California reports that her organization performs testing for T. cruzi is based on customer preference and thus their current protocol is to test 100% of donations. One of the major issues that they foresee with moving to a selective testing protocol (should their customers agree to do so) when the final FDA guidance is released would be the computer system management of donor testing. Perhaps centers that have already moved to selective testing would be willing to share how this is managed. The responding physician is also interested to know if a donor who qualified on a single lifetime nonreactive test result would be retested if they travel to an endemic area.

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