Thromb Haemost 2004; 92(04): 838-845
DOI: 10.1160/TH04-04-0229
Wound Healing and Inflammation / Infaction
Schattauer GmbH

Contamination of coagulation factor concentrates with human parvovirus B19 genotype 1 and 2

Beate Schneider
1   Institute of Medical Microbiology and Immunology
,
Maria Becker
1   Institute of Medical Microbiology and Immunology
,
Hans-Hermann Brackmann
2   Haemophilia Centre, Institute of Experimental Haematology and Transfusion Medicine; University of Bonn, Germany
,
Anna Maria Eis-Hübinger
1   Institute of Medical Microbiology and Immunology
› Author Affiliations

Financial support: This work was carried out with financial support from the Commission of the European Community (Grant QLK2-CT-2001-00877).
Further Information

Publication History

Received 14 April 2004

Accepted after revision 13 July 2004

Publication Date:
06 December 2017 (online)

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Summary

Human parvovirus B19 (B19) DNA has frequently been detected in plasma-derived coagulation factor concentrates. Furthermore, transmission of B19 infection was observed, indicating presence of the infectious virus despite routine viral inactivation/removal procedures during the manufacturing process. Recently, human parvovirus DNA isolates, variant from B19, have been identified resulting in classification of B19 virus into three distinct genotypes, with all viruses previously classified as B19 belonging to genotype 1. So far, there is no information available on contamination of clotting factor concentrates with genotype 2. Therefore, we analysed 202 different factor concentrate lots for genotype 1 and 2 DNA by PCR. Analysis of one hundred eighty-one lots representing 13 different products, administered over the last three years, was compared to 21 lots (8 products) used until the early 1980s which had not been treated by viral inactivation procedures. Genotype 1 DNA was detected in 77/181 (42.5%) currently administered lots, and 17/21 (81%) previously used lots. The level of genotype 1 DNA contamination was similar in currently and previously administered concentrates. Genotype 2 DNA was found in 5/202 (2.5%) lots, all of which were co-contaminated with genotype 1 DNA. DNA sequence analysis showed that the PCR-double positive concentrates contained typical genotype 1 and genotype 2 DNA. Because genotype 2 appears to cause a similar spectrum of diseases as genotype 1, simultaneous detection of genotype 2 by nucleic acid amplification testing (NAT), now widely applied to plasma pools for genotype 1, would give an added level of safety to blood products.