title: Experience of German Red Cross blood donor services with nucleic acid testing: results of screening more than 30 million blood donations for human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus.
abstract: BACKGROUND
  The risk of transfusion-transmitted human immunodeficiency virus-1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) infections is predominantly attributable to donations given during the early stage of infection when diagnostic tests may fail. In 1997, nucleic acid amplification technique (NAT)-testing was introduced at the German Red Cross (GRC) blood donor services to reduce this diagnostic window period (WP).
  
  
  METHODS
  A total of 31,524,571 blood donations collected from 1997 through 2005 were screened by minipool NAT, predominantly with pool sizes of 96 donations. These donations cover approximately 80 percent of all the blood collected in Germany during that period. Based on these data, the WP risk in the GRC blood donor population was estimated by using a state-of-the-art mathematic model.
  
  
  RESULTS
  During the observation period, 23 HCV, 7 HIV-1, and 43 HBV NAT-only-positive donations were detected. On the basis of these data and estimated pre-NAT infectious WPs, the residual risk per unit transfused was estimated at 1 in 10.88 million for HCV (95% confidence interval [CI], 7.51-19.72 million), 1 in 4.30 million for HIV-1 (95% CI, 2.39-21.37 million), and 1 in 360,000 for HBV (95% CI, 0.19-3.36 million). Based on observed cases of breakthrough infections, the risk of transfusion-related infections may be even lower.
  
  
  CONCLUSIONS
  The risk of a blood recipient becoming infected with HCV, HIV-1, or HBV has reached an extremely low level. Introduction of individual donation testing for HCV and HIV-1 would have a marginal effect on interception of WP donations.
authors.affiliation: Institute of Transfusion and Immunohematology, German Red Cross Baden-Württemberg-Hessen, Johann Wolfgang Goethe University, Frankfurt, Germany. k.hourfar@blutspende.de
authors.forename: Michael K
authors.initials: MK
authors.lastname: Hourfar
authors.forename: Christine
authors.initials: C
authors.lastname: Jork
authors.forename: Volkmar
authors.initials: V
authors.lastname: Schottstedt
authors.forename: Marijke
authors.initials: M
authors.lastname: Weber-Schehl
authors.forename: Veronika
authors.initials: V
authors.lastname: Brixner
authors.forename: Michael P
authors.initials: MP
authors.lastname: Busch
authors.forename: Geert
authors.initials: G
authors.lastname: Geusendam
authors.forename: Knut
authors.initials: K
authors.lastname: Gubbe
authors.forename: Christina
authors.initials: C
authors.lastname: Mahnhardt
authors.forename: Uschi
authors.initials: U
authors.lastname: Mayr-Wohlfart
authors.forename: Lutz
authors.initials: L
authors.lastname: Pichl
authors.forename: W Kurt
authors.initials: WK
authors.lastname: Roth
authors.forename: Michael
authors.initials: M
authors.lastname: Schmidt
authors.forename: Erhard
authors.initials: E
authors.lastname: Seifried
authors.forename: David J
authors.initials: DJ
authors.lastname: Wright
mesh_terms: D001782:Blood Donors / Q000706:statistics & numerical data*; D004279:DNA, Viral / Q000097:blood; D005858:Germany / Q000453:epidemiology; D015658:HIV Infections / Q000175:diagnosis / Q000453:epidemiology / Q000635:transmission; D015497:HIV-1; D006509:Hepatitis B / Q000175:diagnosis / Q000453:epidemiology / Q000635:transmission; D006526:Hepatitis C / Q000175:diagnosis / Q000453:epidemiology / Q000635:transmission; D006801:Humans; D015994:Incidence; D008403:Mass Screening / Q000379:methods* / Q000706:statistics & numerical data*; D015233:Models, Statistical; D012011:Red Cross; D018570:Risk Assessment; D012307:Risk Factors; D014777:Virus Diseases / Q000175:diagnosis* / Q000453:epidemiology* / Q000635:transmission
chemical_list: D004279:DNA, Viral