Interagency Genome Amplification Testing Task Force: preliminary report

Abstract

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.To prepare for this new era of transmissible-disease testing, the American Association of Blood Banks initiated the formation of an interagency task force to identify the issues created by the impending GAT and to propose positions or recommendations on those issues.The task force includes representatives from the American Association of Blood Banks, America's Blood Centers, the American Red Cross, the Food and Drug Administration, and the National Institutes of Health and observers from blood services in Canada, France, and the United Kingdom.This document is a report of the initial work of this interagency task force.The task force is reviewing background information and data on the present risks of transfusion-transmitted diseases; the dynamics of infection, especially as related to the window phase; genome-amplification technologies

Cite this work

No public copy is stored for this record, so only the metadata is cited.

Stored only when both papers are in the corpus — 11 citations exist upstream.

Papers that cite the same references — the relational fallback while embeddings are still backfilling.