Collaborative study to establish a World Health Organization International genotype panel for parvovirus B19 DNA nucleic acid amplification technology (NAT)-based assays

Vox Sanguinis

Volumn 102, Issue 3, 2012, Pages 204-211

  Baylis, S A ^a   Ma, L ^b   Padley, D J ^c   Heath, A B ^c   Yu, M W ^b  

^a PAUL EHRLICH INSTITUT   (Germany)

^b CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^c NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

Nucleic acid amplification technique; Parvovirus B19; Standard

Indexed keywords

ARTICLE; ASSAY; CONTROLLED STUDY; GENOTYPE; HUMAN PARVOVIRUS B19; LABORATORY; NONHUMAN; NUCLEIC ACID AMPLIFICATION; NUCLEOTIDE SEQUENCE; PRIORITY JOURNAL; QUALITATIVE ASSAY; QUANTITATIVE ASSAY; REAL TIME POLYMERASE CHAIN REACTION; STANDARD;

DNA, VIRAL; FEMALE; GENOTYPE; HUMANS; MALE; NUCLEIC ACID AMPLIFICATION TECHNIQUES; PARVOVIRIDAE INFECTIONS; PARVOVIRUS B19, HUMAN; WORLD HEALTH ORGANIZATION;

EID: 84858286812     PISSN: 00429007     EISSN: 14230410     Source Type: Journal    
DOI: 10.1111/j.1423-0410.2011.01541.x     Document Type: Article

References (32)

1. Servant A, Laperche S, Lallemand F, et al.: Genetic diversity within human erythroviruses: identification of three genotypes. J Virol 2002; 76:9124-9134
2. Toan NL, Duechting A, Kremsner PG, et al.: Phylogenetic analysis of human parvovirus B19, indicating two subgroups of genotype 1 in Vietnamese patients. J Gen Virol 2006; 87:2941-2949
3. Parsyan A, Szmaragd C, Allain JP, et al.: Identification and genetic diversity of two human parvovirus B19 genotype 3 subtypes. J Gen Virol 2007; 88:428-431
4. Tattersall P, Bergoin M, Bloom ME, et al .: Parvoviridae; in Fauquet CM, Mayo MA, Maniloff J, Desselberger U, Ball LA (eds): Virus Taxonomy: Eighth Report of the International Committee on Taxonomy of Viruses. New York, Academic Press, 2005: 353-369
5. Schmidt I, Blümel J, Seitz H, et al.: Parvovirus B19 DNA in plasma pools and plasma derivatives. Vox Sang 2001; 81:228-235
6. U.S. Food and Drug Administration Blood Products Advisory Committee (1999): Nucleic acid testing of blood donors for human parvovirus B19. Available from: and
7. Tabor E, Yu MW, Hewlett I, et al.: Summary of a workshop on the implementation of NAT to screen donors of blood and plasma for viruses. Transfusion 2000; 40:1273-1275
8. Brown KE, Young NS, Alving BM, et al.: Parvovirus B19: implications for transfusion medicine, summary of a workshop. Transfusion 2001; 41:130-135
9. Parsyan A, Candotti D: Human erythrovirus B19 and blood transfusion - an update. Transfus Med 2007; 17:263-278
10. Blümel J, Burger R, Drosten C, et al.: Arbeitskreis Blut, Untergruppe "Bewertung Blutassoziierter Krankheitserreger". Parvovirus B19 - Revised. Transfus Med Hemother 2010; 37:339-350
11. Saldanha J, Lelie N, Yu MW, et al.: Establishment of the first World Health Organization International Standard for human parvovirus B19 DNA nucleic acid amplification techniques. Vox Sang 2002; 82:24-31
12. Baylis SA, Chudy M, Blümel J, et al.: Collaborative study to establish a replacement World Health Organization international standard for parvovirus B19 DNA nucleic acid amplification technology (NAT)-based assays. Vox Sang 2010; 98:441-446
13. Council of Europe: Human anti-D immunoglobulin, monograph 07/2008:0557; in European Pharmacopoeia, 7th edn. Strasbourg, France, Council of Europe, 2011
14. Council of Europe: Human anti-D immunoglobulin for intravenous administration, monograph 01/2008:1527; in European Pharmacopoeia, 7th edn. Strasbourg, France, Council of Europe, 2011
15. Council of Europe: Human plasma (pooled and treated for virus inactivation), monograph 01/2011:1646; in European Pharmacopoeia, 7th edn. Strasbourg, France, Council of Europe, 2011
16. U.S. Food and Drug Administration Blood Products Advisory Committee (2002): Human parvovirus B19 NAT testing for whole blood and source plasma. Available from:
17. U.S. Food and Drug Administration Guidance for Industry (2009): Nucleic acid testing (NAT) to reduce the possible risk of human parvovirus B19 transmission by plasma-derived products. Available from:
18. Council of Europe: Nucleic acid amplification techniques. 07/2010:20621; in European Pharmacopoeia, 7th edn. Strasbourg, France, Council of Europe, 2011
19. Schneider B, Becker M, Brackmann HH, et al.: Contamination of coagulation factor concentrates with human parvovirus B19 genotype 1 and 2. Thromb Haemost 2004; 92:838-845
20. Modrow S, Wenzel JJ, Schimanski S, et al.: Prevalence of nucleic acid sequences specific for human parvoviruses, hepatitis A and hepatitis E viruses in coagulation factor concentrates. Vox Sang 2011; 100:351-358
21. Nübling M, Buchheit K-H: Results from recent EDQM/OMCL PTS studies (PTS052 and PTS064) on B19 DNA NAT testing of plasma pools; Presentation at the XIX SoGAT meeting, June 14, 2006, Bern, Switzerland
22. Baylis SA, Buchheit K-H: A proficiency testing study to evaluate laboratory performance for the detection of different genotypes of parvovirus B19. Vox Sang 2009; 97:13-20
23. Liefeldt L, Plentz A, Klempa B, et al.: Recurrent high level parvovirus B19/genotype 2 viremia in a renal transplant recipient analysed by real-time PCR for simultaneous detection of genotypes 1 to 3. J Med Virol 2005; 75:161-169
24. Cohen BJ, Gandhi J, Clewley JP: Genetic variants of parvovirus B19 identified in the United Kingdom: implications for diagnostic testing. J Clin Virol 2006; 36:152-155
25. Grabarczyk P, Kalińska A, Kara M, et al.: Identification and characterization of acute infection with parvovirus B19 genotype 2 in immunocompromised patients in Poland. J Med Virol 2011; 83:142-149
26. Baylis SA: Standardization of nucleic acid amplification technique (NAT)-based assays for different genotypes of parvovirus B19: a meeting summary. Vox Sang 2008; 94:74-80
27. Blümel J, Eis-Hübinger AM, Stühler A, et al.: Characterization of parvovirus B19 genotype 2 in KU812Ep6 cells. J Virol 2005; 79:14197-14206
28. Rinckel LA, Brett BR, Gierman TM, et al.: Discovery and analysis of a novel parvovirus B19 genotype 3 isolate in the United States. Transfusion 2009; 49:1488-1492
29. Saldanha J, Gerlich W, Lelie N, et al.: An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniques. Vox Sang 2001; 80:63-71
30. Baylis SA, Shah N, Minor PD: Evaluation of different assays for the detection of parvovirus B19 DNA in human plasma. J Virol Methods 2004; 121:7-16
31. Koppelman MH, Rood IG, Fryer JF, et al.: Parvovirus B19 genotypes 1 and 2 detection with real-time polymerase chain reaction assays. Vox Sang 2007; 93:208-215
32. José M, Gajardo R, Jorquera JI: Stability of HCV, HIV-1 and HBV nucleic acids in plasma samples under long-term storage. Biologicals 2005; 33:9-16