title: Screening the blood supply for West Nile virus RNA by nucleic acid amplification testing.
abstract: BACKGROUND
  The use of nucleic acid amplification tests of "minipools" of 16 samples to screen blood donors for West Nile virus RNA began in July 2003. We report the yield and characteristics of positive donations and the incremental yield and safety of nucleic acid amplification tests of individual donations.
  
  
  METHODS
  Reactive minipools were analyzed to identify the individual reactive donations. For the regions with the highest yield on minipool testing, retrospective nucleic acid amplification testing was performed on individual donations that were negative on minipool testing. Reactive donations were confirmed by alternative nucleic acid amplification tests and IgM and IgG tests, and donors were followed to document seroconversion.
  
  
  RESULTS
  From July 1 through October 31, 2003, 677,603 donations were prospectively screened for West Nile virus by minipool testing, yielding 183 confirmed viremic donations (0.027 percent, or 1 in 3703 donations). Retrospective individual testing of 23,088 donations from high-prevalence regions that were negative on minipool testing yielded 30 additional units with a low level of viremia, with 14 additional viremic units detected by prospective testing of individual donations late in the 2003 transmission season. Of all the viremic units detected, 5 percent were detected only by individual testing and were negative for IgM antibody, 29 percent were detected by individual testing after IgM seroconversion, and 66 percent were detected by minipool testing. West Nile virus infection was confirmed in both recipients of IgM-negative units that were reactive on individual testing, whereas neither recipient of antibody-positive blood components that were reactive on individual testing was infected. In 2004, prospective testing of individual donations in regions that yielded donations that were reactive on minipool testing resulted in a 32 percent incremental yield of units with a low level of viremia that would have been missed by minipool testing.
  
  
  CONCLUSIONS
  Although nucleic acid amplification testing of minipools of blood donations prevented hundreds of cases of West Nile virus infection in 2003, it failed to detect units with a low level of viremia, some of which were antibody-negative and infectious. These data support the use of targeted nucleic acid amplification testing of individual donations in high-prevalence regions, a strategy that was implemented successfully in 2004.
authors.affiliation: Blood Systems Research Institute, San Francisco, USA.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Busch
authors.forename: Sally
authors.initials: S
authors.lastname: Caglioti
authors.forename: Eugene F
authors.initials: EF
authors.lastname: Robertson
authors.forename: Joan D
authors.initials: JD
authors.lastname: McAuley
authors.forename: Leslie H
authors.initials: LH
authors.lastname: Tobler
authors.forename: Hany
authors.initials: H
authors.lastname: Kamel
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Linnen
authors.forename: Venkatakrishna
authors.initials: V
authors.lastname: Shyamala
authors.forename: Peter
authors.initials: P
authors.lastname: Tomasulo
authors.forename: Steven H
authors.initials: SH
authors.lastname: Kleinman
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D001769:Blood / Q000821:virology; D001782:Blood Donors; D001803:Blood Transfusion; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D021141:Nucleic Acid Amplification Techniques; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood*; D012189:Retrospective Studies; D014766:Viremia / Q000097:blood / Q000175:diagnosis; D014901:West Nile Fever / Q000097:blood / Q000175:diagnosis*; D014902:West Nile virus / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*
chemical_list: D000914:Antibodies, Viral; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D012367:RNA, Viral