Interagency Genome Amplification Testing Task Force: preliminary report

nvestigators from the Retroviral Epidemiology in Donors Study suggested several years ago that the use of nucleotide-amplification techniques should be help-I ful in reducing the infectivity of the blood supply.' In 1995, the Commissioner of the United States Food and Drug Administration formally stated the desire to see genome amplification tests developed and implemented for use in the United States blood supply.* In an effort to further improve the safety of plasma derivatives, the Committee for Proprietary Medicinal Products, the European regulatory agency, is now requiring that, by July 1,1999, all derivatives be prepared from plasma that has been tested for hepatitis C virus RNA by a genome-amplification technique. Thus, these forces have stimulated the development of technology to make such testing possible. The National Heart, Lung, and Blood Institute funded several projects involving development of the technology of genome-amplification testing (GAT) during the past several years, and this work appears to have been very s~ccessful.~ Thus, the potential is now nearly at hand to shift blood-screening technology from the detection of the immune response to the infectious agent to the detection of the agent itself. Several major blood collection organizations such as the American Red Cross and America's Blood Centers are making plans to introduce this new approach to transmissible-disease testing.