Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Hua Cai Road 26 Hao, Dong San Huan Road Er Duan, Chengdu, Sichuang 610052, China.
J Transl Med. 2012 Sep 17;10:194. doi: 10.1186/1479-5876-10-194.
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. 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.
Using 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 1x10(4) and 1x10(6) geq/mL using B19 ELISA IgM/IgG assay(Virion-Serion, Würzburg, Germany), respectively.
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 10(2)-10(7) geq/mL. In samples with >10(4) 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 (10(2)-10(8) geq/mL) and one donation had 1.09 × 10(10) geq/mL B19V genomic DNA along with a non-classical IgG/IgM profile.
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.
为确保血浆衍生物的安全性，一些国家采用混合策略对捐献的血浆进行人细小病毒 B19V 基因组 DNA 的筛查。我们调查了中国血浆混合池、血浆衍生物和血浆捐献中 B19V DNA 和抗-B19V 抗体的流行情况，以评估 B19V 带来的风险。
使用我们自主开发的 Q-PCR 检测法，检测了 2009 年 1 月至 2011 年 6 月期间，来自中国两家血液制品制造商的 142 个血浆混合池中的 B19V 基因组 DNA。检测了 1993-1995 年（10 批白蛋白，155 批静脉注射免疫球蛋白，IVIG）和 2009-2011 年（50 批白蛋白，54 批 IVIG，35 批 VIII 因子，7 批纤维蛋白原和 17 批凝血酶原复合物浓缩物，PCC）的血浆衍生物中是否存在 B19V 污染。此外，还检测了中国某制造商于 2011 年 8 月至 2012 年 3 月间采集的 49680 份单个血浆样本的 minipools（包括 90 份个体捐献）中 B19V 基因组的流行情况。还使用 B19 ELISA IgM/IgG 检测试剂盒（Virion-Serion，维尔茨堡，德国）对 B19V-DNA 滴度高于 1x10(4)和 1x10(6) geq/mL 的血浆混合池/衍生物和 minipools 中的 IgM/IgG 进行了检测。
在来自中国两家血液制品制造商的 142 个血浆混合池中，有 54.2% 检测到了 B19V-DNA；在最近生产的血液制品中，21/54 IVIG 样本、19/35 VIII 因子样本、6/7 纤维蛋白原样本和 12/17 PCC 样本中检测到了 B19V，但白蛋白样本中未检测到。这些样本中 B19V-DNA 的水平从 10(2)-10(7) geq/mL 不等。在基因组 DNA 大于 10(4) geq/mL 的样本中，所有相应的血浆混合池和 IVIG 中均检测到了 B19V 特异性 IgG，而在大多数其他血浆衍生物中则未检测到。血浆捐献的筛查表明，大多数 minipools 都被 B19V-DNA 污染（10(2)-10(8) geq/mL），一份捐献物中 B19V 基因组 DNA 的浓度为 1.09×10(10) geq/mL，同时伴有非典型 IgG/IgM 谱。
尽管采用了一些旨在防止病毒污染的灭活/去除方法，但仍能在中国的血浆混合池和血浆衍生物中检测到 B19V DNA。因此，对中国血浆捐献者进行 B19V 筛查和淘汰高病毒浓度的捐献是可取的。
