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Blood Screening by Nucleic Acid Amplification Technology: Current Issues, Future Challenges

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Abstract

Background: Nucleic acid amplification technology (NAT) is presently being evaluated in US clinical trials to determine the safety and efficacy of mini-pool testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) RNA in the blood-donor population. Although the risk for transfusion-transmitted HIV and HCV infection is extremely low, there is still a small chance that blood donated by infected individuals before seroconversion can escape detection by current antibody-based assays.

Methods: This report describes the amplification technologies being used and reviews several issues surrounding NAT-based blood screening. The performance features of NAT and current enzyme immunoassay technologies are compared, and the benefits of NAT in reducing transfusion-transmitted infections are discussed.

Conclusions: The current US clinical trials of mini-pool NAT testing for HIV and HCV RNA have successfully identified preseroconversion infectious blood units. Although the current NAT-based screening systems are semiautomated, mini-pool testing represents an unprecedented innovation among government and nongovernment agencies in the highly regulated blood transfusion industry. Despite cost-effectiveness issues, based on the public perception of infectious diseases acquired through blood transfusion, NAT-based screening of the blood supply is expected to become a standard in transfusion medicine.

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  1. Roche Molecular Systems, Inc, 4300 Hacienda Dr, Pleasanton, CA, 94588, USA

    James L. Gallarda PhD & Elizabeth Dragon PhD

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  1. James L. Gallarda PhD
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  2. Elizabeth Dragon PhD
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Correspondence to James L. Gallarda PhD.

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Gallarda, J.L., Dragon, E. Blood Screening by Nucleic Acid Amplification Technology: Current Issues, Future Challenges. Molecular Diagnosis 5, 11–22 (2000). https://doi.org/10.1007/BF03262018

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