Abstract
BackgroundTo ensure the safety of plasma derivatives, screening for human parvovirus B19V genomic DNA in donated plasma using a pooling strategy is performed in some countries. We investigated the prevalence of B19V DNA and anti-B19V antibodies in Chinese plasma pools, plasma derivatives and plasma donations to evaluate the risk posed by B19V.MethodsUsing a Q-PCR assay developed in-house, we tested for B19V genomic DNA in 142 plasma pools collected between January 2009 and June 2011 from two Chinese blood products manufacturers. Plasma derivatives collected between 1993–1995 (10 batches of albumin, 155 batches of intravenous immunoglobulin, IVIG) and 2009–2011 (50 batches of albumin, 54 batches of IVIG, 35 batches of factor VIII, 7 batches of fibrinogen, and 17 batches of prothrombin complex concentrate, PCC) were also tested for B19V contamination. In addition, B19V genome prevalence in minipools(including 90 individual donations) of 49680 individual plasma samples collected between August 2011 and March 2012 by a single Chinese manufacturer was investigated. IgM/IgG was also investigated in plasma pools/derivatives and in minipools with B19V-DNA titers above 1x104 and 1x106 geq/mL using B19 ELISA IgM/IgG assay(Virion-Serion, Würzburg, Germany), respectively.ResultsB19V-DNA was detected in 54.2% of plasma pools from two Chinese blood product manufacturers; among recently produced blood products, B19V was detected in 21/54 IVIG samples, 19/35 factor VIII samples, 6/7 fibrinogen samples, and 12/17 PCC samples, but not in albumin samples. The levels of B19V-DNA in these samples varied from 102-107 geq/mL. In samples with >104 geq/mL genome DNA, B19V-specific IgG was also found in all corresponding plasma pools and IVIG, whereas none was detected in the majority of other plasma derivatives. Screening of plasma donations indicated that most minipools were contaminated with B19V-DNA (102-108 geq/mL) and one donation had 1.09 × 1010 geq/mL B19V genomic DNA along with a non-classical IgG/IgM profile.ConclusionsDespite the implementation of some inactivation/removal methods designed to prevent viral contamination, B19V DNA was detectable in Chinese plasma pools and plasma derivatives. Thus, the introduction of B19V screening and discard donation with high viramic concentration for Chinese plasma donors would be desirable.
Highlights
To ensure the safety of plasma derivatives, screening for human parvovirus B19V genomic DNA in donated plasma using a pooling strategy is performed in some countries
Overall, 85% (60–100% depending on manufacturer) of plasma pools, 25% of albumin samples, 100% of factor VIII, 20% of Intravenous immunoglobulin (IVIG), and 75% of intramuscular immunoglobulin preparations contained B19V DNA [10]
We aimed to determine the frequency and level of B19V DNA contamination in plasma pools collected during 2009–2011, and in plasma-derived products produced during two periods,1993–1995 and 2009–2011(albumin, IVIG, factor VIII, Fibrinogen), under license in China
Summary
To ensure the safety of plasma derivatives, screening for human parvovirus B19V genomic DNA in donated plasma using a pooling strategy is performed in some countries. Human parvovirus B19V is a small icosahedral, nonenveloped single-stranded DNA viral pathogen that can cause a variety of diseases, including erythema infectiosum (fifth disease), arthritis, transient aplastic crisis, contaminate most plasma pools used for fractionation [8,9], and, eventually, plasma derivatives that are usually prepared from pools of several thousand donations. Overall, 85% (60–100% depending on manufacturer) of plasma pools, 25% of albumin samples, 100% of factor VIII, 20% of IVIG, and 75% of intramuscular immunoglobulin preparations contained B19V DNA [10]. Viral load in those samples ranged from 1 × 102 to 1 × 106 geq/mL. European Pharmacopoeia has imposed a limit of 104 IU/mL for levels of B19V in antiD immunoglobulins and pooled virus inactivated plasma
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