title: Evaluation of two, commercial, multi-dye, nucleic acid amplification technology tests, for HBV/HCV/HIV-1/HIV-2 and B19V/HAV, for screening blood and plasma for further manufacture.
abstract: BACKGROUND
  The cobas TaqScreen MPX Test, version 2.0, a multiplex, multi-dye nucleic acid amplification technology (NAT) test from Roche was evaluated by two European Blood Banks, the German Red Cross Blood Donor Service, Frankfurt, Germany and Centro de Hemoterapia y Hemodonación de Castilla y León, Valladolid, Spain. In addition, the cobas TaqScreen DPX Test was evaluated for the simultaneous detection and quantitation of parvovirus B19 and the detection of hepatitis A virus (HAV).
  
  
  METHODS
  The performances of the two tests were evaluated regarding the analytical sensitivity, the reproducibility of the tests using samples containing low concentrations of each virus and cross-contamination using samples containing high titres of virus.
  
  
  RESULTS
  The analytical sensitivity of the MPX Test, version 2.0, obtained by the German Red Cross Blood Donor Service was 1·1, 3·9 and 43·3 IU/ml for HBV, HCV and HIV-1, respectively. The comparable analytical sensitivity at Centro de Hemoterapia y Hemodonación de Castilla y León was 3·5, 17·6 and 50·6 IU/ml for HBV, HCV and HIV-1, respectively. The analytical sensitivity of the DPX test determined by the German Red Cross Blood Donor Service was 0·6 and 3·8 IU/ml for HAV and B19.
  
  
  CONCLUSIONS
  These multiplex and multi-dye blood screening assays represent a flexible NAT screening system for mini-pools between 6 and 96 samples per pool and fulfil all requirements of the European Pharmacopoeia for HCV and B19V testing of plasma for fractionation. The inclusion of a new multi-dye technology means discriminatory assays are no longer required for either test thus improving workflow, turn-around time and minimize the risk of obtaining a reactive result for which the virus cannot be identified.
authors.affiliation: German Red Cross Blood Donor Service, Frankfurt Institute of Transfusion Medicine and Immunohematology, Johann Wolfgang Goethe University, Frankfurt, Germany.
authors.forename: M M
authors.initials: MM
authors.lastname: Müller
authors.forename: M I G
authors.initials: MI
authors.lastname: Fraile
authors.forename: M K
authors.initials: MK
authors.lastname: Hourfar
authors.forename: L B
authors.initials: LB
authors.lastname: Peris
authors.forename: W
authors.initials: W
authors.lastname: Sireis
authors.forename: M G
authors.initials: MG
authors.lastname: Rubin
authors.forename: E M
authors.initials: EM
authors.lastname: López
authors.forename: G T
authors.initials: GT
authors.lastname: Rodriguez
authors.forename: E
authors.initials: E
authors.lastname: Seifried
authors.forename: J
authors.initials: J
authors.lastname: Saldanha
authors.forename: M
authors.initials: M
authors.lastname: Schmidt
mesh_terms: D001771:Blood Banks; D001782:Blood Donors; D058731:Blood Safety; D005060:Europe; D005838:Genotype; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000235:genetics; D015498:HIV-2 / Q000235:genetics; D016174:Hepacivirus / Q000235:genetics; D006506:Hepatitis A / Q000175:diagnosis / Q000821:virology; D030041:Hepatitis A virus / Q000235:genetics; D006509:Hepatitis B / Q000175:diagnosis* / Q000821:virology; D006515:Hepatitis B virus / Q000235:genetics; D006526:Hepatitis C / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D008403:Mass Screening; D021141:Nucleic Acid Amplification Techniques; D016732:Parvovirus B19, Human / Q000235:genetics; D015203:Reproducibility of Results