title: Testing of individual blood donations for HCV RNA reduces the residual risk of transfusion-transmitted HCV infection.
abstract: BACKGROUND
  To allow cost-effective RNA testing with NAT techniques, the national authorities of several countries have planned or already introduced tests of mixed specimens, that is, plasma pools.
  
  
  METHODS
  High-throughput extraction, amplification, and detection of HCV RNA from individual blood donations were optimized and validated. The feasibility of the method and the frequency of anti-HCV-negative, HCV RNA-positive donations were determined in a prospective study of 27,745 allogeneic and 792 autologous individual donations.
  
  
  RESULTS
  The 50- and 95-percent detection limits of the method were determined at 44 IU per mL and 162 IU per mL, respectively (World Health Organization HCV reference material). When 201 HCV RNA-positive sera were taken as a reference, the sensitivity was 97.5 percent. The assay specificity was determined at 99.77 percent. During a 20-month period, two seronegative blood donors tested positive in HCV PCR. The viral load of these donations was 6 x 10(6) and 3 x 10(7) copies per mL, respectively. Thus, the yield of HCV RNA testing in this study was 7. 63 per 100,000 screened donations (95% CI, 1.25-22.07). In both PCR-positive donors, seroconversion was found in subsequent blood samples.
  
  
  CONCLUSIONS
  This study compares the feasibility of single-donation HCV RNA screening, with the detection of a relatively high percentage of window-phase donations, to data reported from groups using HCV RNA testing of plasma pools. The relative yield of NAT of individual donations versus minipools should be directly investigated in the near future.
authors.affiliation: Departments of Transfusion Medicine, Medical Statistics, and Virology, University of Göttingen, Göttingen, Germany.
authors.forename: T J
authors.initials: TJ
authors.lastname: Legler
authors.forename: J
authors.initials: J
authors.lastname: Riggert
authors.forename: G
authors.initials: G
authors.lastname: Simson
authors.forename: C
authors.initials: C
authors.lastname: Wolf
authors.forename: A
authors.initials: A
authors.lastname: Humpe
authors.forename: U
authors.initials: U
authors.lastname: Munzel
authors.forename: A
authors.initials: A
authors.lastname: Uy
authors.forename: M
authors.initials: M
authors.lastname: Köhler
authors.forename: K H
authors.initials: KH
authors.lastname: Heermann
mesh_terms: D001782:Blood Donors; D005189:False Positive Reactions; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000453:epidemiology / Q000635:transmission; D006801:Humans; D012367:RNA, Viral / Q000097:blood*; D015203:Reproducibility of Results; D012307:Risk Factors; D012680:Sensitivity and Specificity; D065227:Transfusion Reaction
chemical_list: D012367:RNA, Viral