title: First case of hepatitis C virus transmission by a red blood cell concentrate after introduction of nucleic acid amplification technique screening in Germany: a comparative study with various assays.
abstract: OBJECTIVE
  Pooled nucleic acid amplification techniques (NAT) and donor screening for anti-hepatitis C virus (HCV) have reduced the diagnostic window period of HCV infection in the blood donor population from about 12 to 1 or 2 weeks. During that time, HCV RNA is hardly detectable by pooled or individual donation NAT. Here we describe a case of transfusion-acquired HCV infection from an extremely low-titre donation. After a repeat donor tested positive for HCV, a look-back procedure was initiated. A recipient of a red cell concentrate from the previous donation was identified and found to be infected with HCV as well. We compared several commercial NAT systems for their ability to detect the viraemic plasma.
  
  
  METHODS
  Molecular analyses of HCV in donor and recipient samples were performed. The HCV-transmitting plasma was tested using different commercially available qualitative and quantitative NAT assays.
  
  
  RESULTS
  HCV transmission was verified by molecular analyses and was assigned to genotype 2b. NAT with various commercial HCV assays detected the infection erratically in individual donations. However, the detection rate was not directly related to the claimed sensitivity of some HCV NATs.
  
  
  CONCLUSIONS
  HCV transmission can be caused by donations that escape NAT detection even when tested in an individual donation. Comparison of different assays led to results that did not necessarily reflect the expected sensitivities. The need for standard materials representing further HCV genotypes is discussed.
authors: Institute for Clinical Haemostaseology, Duisburg, Germany. ek@trobisch.de
authors: E
authors: E
authors: Kretzschmar
authors: M
authors: M
authors: Chudy
authors: C M
authors: CM
authors: Nübling
authors: R S
authors: RS
authors: Ross
authors: F
authors: F
authors: Kruse
authors: H
authors: H
authors: Trobisch
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001483:Base Sequence; D001782:Blood Donors; D004279:DNA, Viral / Q000235:genetics; D046148:Donor Selection / Q000379:methods*; D017707:Erythrocyte Transfusion / Q000009:adverse effects*; D005260:Female; D005858:Germany; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification; D006526:Hepatitis C / Q000175:diagnosis / Q000635:transmission* / Q000821:virology; D006801:Humans; D008297:Male; D008969:Molecular Sequence Data; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D012367:RNA, Viral / Q000097:blood / Q000235:genetics; D012189:Retrospective Studies; D014766:Viremia / Q000175:diagnosis / Q000821:virology
chemical_list: D004279:DNA, Viral; D012367:RNA, Viral