Parvovirus B19V DNA contamination in Chinese plasma and plasma derivatives

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.

The prevalence of hepatitis A virus and parvovirus B19 in source‐plasma donors and whole blood donors in China

“…Our prevalence data in WB donors was significantly lower than the prevalence reported by Ke et al () (0·58%), by Wang et al () (2·67%) and by Yu et al () (6·80%). In addition, we found two minipools (including 96 individual source plasma donations) positive for B19V DNA (3·77%, 2/53) which was significantly lower than that reported by Zhang et al () in which most minipools (including 90 individual source plasma donations) were contaminated with B19V DNA (97%, 536/552). This surprising difference may be due to three factors.…”

“…In our study, the samples were collected from the donors in Sichuan province which is located in the southwest of China. It is known that winter and spring are the epidemic periods of respiratory virus in this area (Zhang et al , ). However, the donations of our study were collected from July to December in 2013 which was not the epidemic period.…”

The genomic and seroprevalence of human bocavirus in healthy Chinese plasma donors and plasma derivatives

“…Plasma samples screened in this study consisted of 6096 individual plasma samples collected from one Chinese blood product manufacturer between October 2012 and September 2013 (October 2012, 893 samples; November 2012, 90; December 2012, 714; January 2013, 719; February 2013, 711; March 2013, 630; April 2013, 90; May 2013, 630; June 2013, 449; July 2013, 450; August 2013, 360; September 2013, 360), 241 plasma pools, and 326 batches of blood products (including 65 batches of albumin, 197 batches of intravenous immunoglobulin [IVIG], 47 batches of anti‐hemophilic Factor VIII [FVIII], 12 batches of fibrinogen, and five batches of prothrombin complex concentrate [PCC]) that had been collected in our laboratory during 2010 to 2012. All the samples tested negative for routine pathogens according to standards established by the Chinese Ministry of Health (routine pathogens were tested by the blood product manufacturers) …”

Viral metagenomics and blood safety

“…Several inactivation procedures are available but some of them are recognized to be less effective on non-enveloped viruses, such as human parvovirus B19 (B19 V), Hepatitis A (HAV) or Hepatitis E (HEV) viruses [2]. Moreover, recent publications have also confirmed that some viral reduction methods (solvent/detergent and heat treatment) are inadequate to inactivate high viremic titers of these viruses in plasma pools or derivates [3,4]. Given this, the threat for blood safety due to emerging viruses is of crucial importance.…”