title: Inactivation and neutralization of parvovirus B19 Genotype 3.
abstract: BACKGROUND
  Parvovirus B19 (B19V) is a common contaminant of human plasma donations. Three B19V genotypes have been defined based on their DNA sequence. Reliable detection of Genotype 3 DNA has proved problematic because of unexpected sequence variability. B19V Genotype 3 is found primarily in West Africa, but was recently detected in plasma from a North American donor. The safety of plasma-derived medicinal products, with respect to B19V, relies on exclusion of high-titer donations, combined with virus clearance at specific manufacturing steps. Studies on inactivation of B19V are difficult to perform and inactivation of Genotype 3 has not yet been investigated.
  
  
  METHODS
  Inactivation of B19V Genotypes 3 and 1 by pasteurization of human serum albumin and incubation at low pH was studied using a cell culture assay for infectious virus particles. Infected cells were detected by reverse transcription-polymerase chain reaction analysis of virus capsid mRNA. Neutralization of B19V Genotype 3 was investigated using human immunoglobulin preparations.
  
  
  RESULTS
  Genotypes 1 and 3 displayed comparable inactivation kinetics during pasteurization of albumin at 56°C, as well as by incubation at various low-pH conditions (pH 4.2 at 37°C and pH 4.5 at 23°C, respectively) used in immunoglobulin manufacturing. Both Genotypes were readily neutralized by pooled immunoglobulin preparations of North American or European origin.
  
  
  CONCLUSIONS
  Pasteurization and low-pH treatment were equally effective in inactivating B19V Genotypes 1 and 3. Neutralization experiments indicated that pooled immunoglobulin of North American or European origin is likely to be equally effective in treatment of disease induced by both genotypes.
authors.affiliation: Paul-Ehrlich-Institut, Langen, Germany. Johannes.Bluemel@pei.de
authors.forename: Johannes
authors.initials: J
authors.lastname: Blümel
authors.forename: Lori A
authors.initials: LA
authors.lastname: Rinckel
authors.forename: Douglas C
authors.initials: DC
authors.lastname: Lee
authors.forename: Nathan J
authors.initials: NJ
authors.lastname: Roth
authors.forename: Sally A
authors.initials: SA
authors.lastname: Baylis
mesh_terms: D016913:Blood Component Transfusion / Q000379:methods; D005838:Genotype; D006801:Humans; D006863:Hydrogen-Ion Concentration; D016732:Parvovirus B19, Human; D061352:Pasteurization / Q000379:methods*; D010949:Plasma / Q000821:virology*; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods; D038301:Virus Inactivation