title: Blood screening by nucleic acid amplification technology: current issues, future challenges.
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.
authors.affiliation: Roche Molecular Systems, Inc, Pleasanton, CA 94588, USA. James.Gallarda@Roche.com
authors.forename: J L
authors.initials: JL
authors.lastname: Gallarda
authors.forename: E
authors.initials: E
authors.lastname: Dragon
mesh_terms: D001331:Automation; D001769:Blood / Q000821:virology*; D000094902:Blood Banking / Q000379:methods; D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D005544:Forecasting; D006678:HIV / Q000302:isolation & purification; D016174:Hepacivirus / Q000302:isolation & purification; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D016133:Polymerase Chain Reaction / Q000379:methods*; D012307:Risk Factors