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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Panel/Roundtable Discussions - FDA Workshop on Testing for Malarial Infections in Blood Donors

Session I: Panel Discussion

Moderator: Monica Parise

Panelists: Sanjai Kumar, Christian Ockenhouse, Alan Williams

Q1. What are the main sources of malaria risk to the US blood supply?

Q2. How effective are the current safety interventions?


Session II: Panel Discussion

Moderator: Peter Chiodini

Panelists: John Barnwell, Jon Daugherty, P. Nigel Appleton, Freddie Poole, Marianna Wilson, Sanjai Kumar

Q1: How sensitive and specific are the available tests for malaria in detecting the infection at different clinical stages, and for different Plasmodium species?


Session III: Panel Discussion

Moderator: Roger Dodd

Panelists: Celso Bianco, Peter Chiodini, Olivier Garraud, Susan Stramer, David Leiby, Steven Anderson, Louis Katz, Steven Kleinman

Q1. What are the lessons learned from testing for malaria antibodies amongst blood donors in Europe and Australia?

Q2. What are the pros and cons of universal donor screening compared with testing only for donor reentry?


Session IV. Round Table Discussions

Moderator: Jay Epstein, M.D

Panelists: Hira Nakhasi, Monica Parise, Matthew Kuehnert, Alan Williams, Peter Chiodini, Roger Dodd, Jerry Holmberg, Tom McCutchan, Louis Katz, Olivier Garraud, Steven Anderson

 

  1. What are the desirable characteristics of laboratory tests to detect malaria infections in blood donors?

     

  2. What are the risks and benefits of donor screening for malaria infections in lieu of risk-based deferrals?

     

  3. What are the prospects for the use of a malaria antibody test in the US?
    I. To screen blood donors;
    II. To reenter deferred blood donors

     

  4. What are the prospects for the use of DNA-based methods as blood screening tests in the US?