Analysis of B19 virus contamination in plasma pools for manufacturing, by using a competitive polymerase chain reaction assay

Background and Objectives The presence of B19 virus in blood poses a risk of transmission of the virus via blood or blood products. Screening processes for manufacturing should be aimed at achieving production plasma pools with B19 virus contamination levels below 104 genome equivalents/ml (geq/ml) in order to prevent transmission of infection through plasma derivatives.

[1]  E. Ben-hur,et al.  Efforts in minimizing risk of viral transmission through viral inactivation , 2000, Annals of medicine.

[2]  D. Gibellini,et al.  Rapid screening for B19 parvovirus DNA in clinical specimens with a digoxigenin-labeled DNA hybridization probe , 1990, Journal of clinical microbiology.

[3]  I. Hewlett,et al.  Summary of a workshop on the implementation of NAT to screen donors of blood and plasma for viruses , 2000, Transfusion.

[4]  J. V. Gool,et al.  ACRODERMATITIS ENTEROPATHICA AND CELLULAR IMMUNE DEFICIENCY , 1976, The Lancet.

[5]  J. Goldman,et al.  Chronic anemia due to parvovirus B19 infection in a bone marrow transplant patient after platelet transfusion , 1997, Transfusion.

[6]  M. Thauvin,et al.  B19 parvovirus DNA in solvent/detergent-treated anti-haemophilia concentrates , 1994, The Lancet.

[7]  P. Mannucci,et al.  The transfusion-associated transmission of parvovirus B19. , 1999, Transfusion medicine reviews.

[8]  R. Kaiser,et al.  Serological and Virological Markers of Human Parvovirus B19 Infection in Sera of Hemophiliacs , 1994, Thrombosis and Haemostasis.

[9]  M. Zerbini,et al.  Quantitation of parvovirus B19 DNA sequences by competitive PCR: differential hybridization of the amplicons and immunoenzymatic detection on microplate. , 1997, Molecular and cellular probes.

[10]  K. Pasi,et al.  Transmission of Human Parvovirus B19 by Coagulation Factor Concentrates , 1990, Vox sanguinis.

[11]  K. Pasi,et al.  Transmission of symptomatic parvovirus B19 infection by clotting factor concentrate , 1996, British journal of haematology.

[12]  P. Mortimer,et al.  TRANSMISSION OF SERUM PARVOVIRUS-LIKE VIRUS BY CLOTTING-FACTOR CONCENTRATES , 1983, The Lancet.

[13]  M. Zerbini,et al.  Standardization of a PCR–ELISA in serum samples: Diagnosis of active parvovirus B19 infection , 1999, Journal of medical virology.

[14]  M Gessner,et al.  A quantitative, internally controlled real-time PCR Assay for the detection of parvovirus B19 DNA. , 2001, Journal of virological methods.

[15]  T. Eastlund,et al.  Clinical illness due to parvovirus B19 infection after infusion of solvent/detergent‐treated pooled plasma , 2000, Transfusion.

[16]  M. Morfini,et al.  Letter to the editor: Hypoplastic anemia in a hemophiliac first infused with a solvent/detergent treated factor VIII concentrate: The role of human B19 parvovirus , 1992, American journal of hematology.

[17]  T. Weimer,et al.  High‐titer screening PCR: a successful strategy for reducing the parvovirus B19 load in plasma pools for fractionation , 2001, Transfusion.

[18]  G Siegl,et al.  Presence and significance of parvovirus B19 in blood and blood products. , 1998, Biologicals : journal of the International Association of Biological Standardization.

[19]  J. Saldanha,et al.  Detection of human parvovirus B19 DNA in plasma pools and blood products derived from these pools: implications for efficiency and consistency of removal of B19 DNA during manufacture , 1996, British journal of haematology.

[20]  J. Clewley,et al.  SYMPTOMATIC PARVOVIRUS B19 INFECTION AND HEAT-TREATED FACTOR IX CONCENTRATE , 1989, The Lancet.

[21]  P. Schwind,et al.  Screening blood donations for parvovirus B19 , 1995, The Lancet.

[22]  C. Prowse,et al.  Human Parvovirus B19 and Blood Products , 1997, Vox sanguinis.

[23]  M. Morfini,et al.  Transmission of parvovirus B19 by coagulation factor concentrates exposed to 100°C heat after lyophilization , 1997 .

[24]  S. Doyle,et al.  High-Sensitivity PCR Detection of Parvovirus B19 in Plasma , 2002, Journal of Clinical Microbiology.

[25]  R. Dodd.  Current viral risks of blood and blood products , 2000, Annals of medicine.

[26]  A. Zanella,et al.  Transfusion‐transmitted human parvovirus B19 infection in a thalassemic patient , 1995, Transfusion.

[27]  S. Tsuji,et al.  Transient hypoplastic anemia caused by primary human parvovirus B19 infection in a previously untreated patient with hemophilia transfused with a plasma-derived, monoclonal antibody-purified factor VIII concentrate. , 1999, Journal of pediatric hematology/oncology.

[28]  M. Vidaud,et al.  Large–Scale Screening for Human Parvovirus B19 DNA by PCR: Application to the Quality Control of Plasma for Fractionation , 2000, Vox Sanguinis.

[29]  Takayuki Takubo,et al.  Transmission of symptomatic parvovirus B19 infection by fibrin sealant used during surgery , 2000, British journal of haematology.

[30]  K. Zakrzewska,et al.  Human parvovirus B19 in clotting factor concentrates: B19 DNA detection by the nested polymerase chain reaction , 1992, British journal of haematology.

[31]  M. Morfini,et al.  Human parvovirus infection in haemophiliacs first infused with treated clotting factor concentrates , 1988, Journal of medical virology.

[32]  P. Mannucci,et al.  Human parvovirus B19 infection in hemophiliacs first infused with two high‐purity, virally attenuated factor Vlll concentrates , 1992, American journal of hematology.

[33]  P. Simmonds,et al.  Detection of parvovirus B19 in donated blood: a model system for screening by polymerase chain reaction , 1993, Journal of clinical microbiology.

[34]  J. Kiss,et al.  Human Parvovirus B19: Prevalence of Viral DNA in Volunteer Blood Donors and Clinical Outcomes of Transfusion Recipients , 1998, Vox sanguinis.

[35]  P. Mannucci,et al.  B19 Parvovirus Withstands “Super Heating” in Antihemophilic Concentrates , 1996, Thrombosis and Haemostasis.

[36]  N. Young,et al.  Parvovirus B19: implications for transfusion medicine. Summary of a workshop , 2001, Transfusion.

[37]  C. S. Jones.  REGIONAL CURARISATION. ANAESTHESIA FOR SURGERY OF THE KNEE-JOINT. , 1963, Lancet.

[38]  A. Roda,et al.  Application of a low-light imaging device and chemiluminescent substrates for quantitative detection of viral DNA in hybridization reactions. , 1995, Clinical chemistry.

[39]  K. Matsumoto,et al.  Screening of Blood Donors for Human Parvovirus B19 and Characterization of the Results , 1999, Vox Sanguinis.