Nucleic Acid Amplification Testing and Blood Safety : What is the Paradigm ?

Over the past 2 decades the pendulum of blood safety policy has swung wide and hit hard. Intense criticism of delayed responses to the early clues of the transfusion AIDS epidemic and of tolerance to the long standing problem of post-transfusion hepatitis has had enormous repercussions.( 1) Blood collection systems in a number of countries have been completely restructured. Policy makers and physicians hale gone to jail. Over the past five years the working paradigm has shifted toward “the precautionary principle” and the elusive mirage of a “zero risk” blood supply. However, recent commentary on the precautionary principle suggests that eventhis conservative approach must not seek zero risk or involve disproportionate responses, but rather should incorporate scientific data, consistency with comparable situations, and cost-benefit analyses into precautionary decision making.(2) In this issue of Transfusion, a number of papers on Nucleic Acid Amplification Testing (NAT) for infectious agents, illustrate some of the very different drivers that have influenced the formulation of blood safety policy: perception, science, ethics, international politics and economics. A review of the data and issues raised in these papers presents the opportunity to discuss recent evolution of blood safety decision making, and thus attempt to answer, or better yet influence, the question posed in the title of this editorial.

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[2]  Arturo Pereira,et al.  A model of the health and economic impact of posttransfusion hepatitis C: application to cost‐effectiveness analysis of further expansion of HCV screening protocols , 2000, Transfusion.

[3]  I. Hewlett,et al.  Summary of a workshop on the implementation of NAT to screen donors of blood and plasma for viruses , 2000, Transfusion.

[4]  H. Klein,et al.  Will blood transfusion ever be safe enough? , 2000, Transfusion medicine.

[5]  M. Kalish,et al.  Failure of routine HIV-1 tests in a case involving transmission with preseroconversion blood components during the infectious window period. , 2000, JAMA.

[6]  S. Glynn,et al.  Trends in incidence and prevalence of major transfusion-transmissible viral infections in US blood donors, 1991 to 1996. , 2000 .

[7]  S. Stramer,et al.  Indeterminate results in blood donor testing: what you don't know can hurt you. , 2000, Transfusion medicine reviews.

[8]  P. Schmidt Blood Feuds: AIDS, Blood, and the Politics of Medical Disaster , 2000 .

[9]  W. Gerlich,et al.  Hepatitis C virus transmission by a blood donation negative in nucleic acid amplification tests for viral RNA , 2000, The Lancet.

[10]  H C Tuckwell,et al.  Direct HIV testing in blood donations: variation of the yield with detection threshold and pool size , 1999, Transfusion.

[11]  J. Allain,et al.  Redefining the HIV‐infectious window period in the chimpanzee model: evidence to suggest that viral nucleic acid testing can prevent blood‐borne transmission , 1999, Transfusion.

[12]  J. Birkmeyer,et al.  Safety of the Blood Supply in the United States: Opportunities and Controversies , 1997, Annals of Internal Medicine.

[13]  S. Kleinman,et al.  The incidence/window period model and its use to assess the risk of transfusion-transmitted human immunodeficiency virus and hepatitis C virus infection. , 1997, Transfusion medicine reviews.

[14]  J. Birkmeyer,et al.  Cost‐effectiveness of expanded human immunodeficiency virus‐testing protocols for donated blood , 1997, Transfusion.

[15]  S. Kleinman,et al.  The Risk of Transfusion-Transmitted Viral Infections , 1996 .

[16]  K R Foster,et al.  Risk management. Science and the precautionary principle. , 2000, Science.

[17]  M. Busch,et al.  HIV, HBV and HCV: new developments related to transfusion safety. , 2000, Vox sanguinis.