Thus, the data obtained in this study does not reflect the nationwide status of B19V contamination of blood products in China and our results do not provide information about regional and temporal differences in contamination prevalence

Thus, the data obtained in this study does not reflect the nationwide status of B19V contamination of blood products in China and our results do not provide information about regional and temporal differences in contamination prevalence. geq/mL using B19 ELISA IgM/IgG assay(Virion-Serion, Wrzburg, Germany), respectively. Results B19V-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, Rabbit Polyclonal to AKT1/2/3 (phospho-Tyr315/316/312) 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 L-(-)-α-Methyldopa (hydrate) 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. Conclusions Despite 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. Background Human parvovirus B19V is usually a small icosahedral, non-enveloped single-stranded DNA viral pathogen that can cause a variety of diseases, including erythema infectiosum (fifth disease), arthritis, transient aplastic crisis, chronic anemia (in immunocompromised patients), hydrops fetalis, and fetal death [1-4]. The main route of B19V transmission is usually via the respiratory route, although it can also be transmitted vertically and via blood transfusion and organ transplantation [5]. B19V contamination usually happens during childhood; however, 40C60% of adults are still susceptible to primary contamination [6,7]. Depending on assay sensitivity and epidemic incidence, the prevalence of B19V DNA in blood donors can be up to 1%, with computer virus titers reaching 1??1014 geq/mL during early acute contamination, although affected individuals are often asymptomatic. This level of prevalence is sufficient to contaminate most plasma pools used for fractionation [8,9], and, eventually, plasma derivatives that are usually prepared from pools of several thousand donations. One study exhibited that, overall, 85% (60C100% 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 1??106 geq/mL. Another study reported a high prevalence (over 60%) of B19V DNA in factor IX, factor VIII, PCCs, and plasma pools with viral loads of 1??102 to 1 1??108 geq/mL [11]. The small size (20C25 nm in diameter) and non-enveloped nature of L-(-)-α-Methyldopa (hydrate) B19V render it difficult to remove by filtration methods and very resistant to many computer virus inactivation procedures used in the production of plasma derivatives, including solvent/detergent (S/D) and heat treatment. The transmission of B19V through the administration of S/D-treated [12] and certain dry heat-treated blood products has already been documented [13-15]. B19V can also be transmitted by blood component [16,17], while one study indicated only high concentration made up of component can cause contamination [18]. Transmission of B19V by blood and blood products and its L-(-)-α-Methyldopa (hydrate) resistance to common viral inactivation/removal methods raises the importance of detecting B19V prior to blood transfusion. The FDA has proposed a limit of 104 geq/mL for manufacturing pools destined for all those plasma derivatives to reduce the potential risk of transmission [19,20]. Similarly, European Pharmacopoeia has imposed a limit of 104 IU/mL for levels of B19V in anti-D immunoglobulins and pooled computer virus inactivated plasma. Many studies have demonstrated the presence of B19V DNA in plasma pools and plasma-derived products [11,21-24]; however, the prevalence of B19V DNA in Chinese blood products and plasma pools has not been extensively investigated. In this study, we aimed to determine the frequency and level of B19V DNA contamination in plasma pools collected during.