US NAT yield: where are we after 2 years?

Susan L. Stramer

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Blood donation and transfusion practices HIV Research and Treatment Blood transfusion and management

Abstract

The US blood supply has been tested for human immunodeficiency virus-1 (HIV-1) and hepatitis C virus (HCV) using nucleic acid amplification testing (NAT) of pools of small number of samples since early 1999. Since the implementation of NAT under an investigational new drug (IND) application, the results for the yield and false positivity have been remarkably consistent for greater than 2 years of testing even among multiple programmes using two different test methodologies and manufacturers: Gen-Probe/Chiron transcription-mediated amplification (TMA) and Roche polymerase chain reaction. All programmes in the US and Canada use NAT as a criterion for cellular as well as frozen product release. The focus of this paper is to provide an update of the programmes in the US and Canada, provide data in support of p24 antigen replacement by HIV-1 NAT and discuss the projections of residual risk of HIV, HCV and hepatitis B virus (HBV) following NAT and the associated cost/benefit.

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References

1996The Risk of Transfusion-Transmitted Viral Infections 1999Feasibility and efficacy of routine PCR screening of blood donations for hepatitis C virus, hepatitis B virus, and HIV-1 in a blood-bank setting 2000Nucleic acid amplification testing of blood donors fortransfusion‐transmitted infectious diseases 1997The incidence/window period model and its use to assess the risk of transfusion-transmitted human immunodeficiency virus and hepatitis C virus infection 2000NAT of the United States and Canadian blood supply 1995Declining value of alanine aminotransferase in screening of blood donors to prevent posttransfusion hepatitis B and C virus infection. The Retrovirus Epidemiology Donor Study 1998False-Positive HIV-1 Test Results in a Low-Risk Screening Setting of Voluntary Blood Donation 2000NAT and blood safety: what is the paradigm?

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2007HIV-1, HCV and HBV seronegative window reduction by the new Roche cobas® TaqScreen MPX test in seroconverting donors 2003Detection of an early HIV‐1 infection by HIV RNA testing in an Italian blood donor during the preseroconversion window period

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