title: Prevalence of human parvovirus B19 in Chinese plasma pools for manufacturing plasma derivatives.
abstract: BACKGROUND
  Human parvovirus B19 (B19V) is a frequent contaminant of blood and plasma-derived medicinal products. To ensure the quality and safety of plasma-derived products, European regulations, Plasma Protein Therapeutics Association (PPTA) standard and FDA guidelines require testing of manufacturing plasma for parvovirus B19 DNA to limit the load of this virus. In China, however, there have been no related documentation and technical guiding principles for monitoring B19V, moreover, an adequate level of information on the prevalence of B19V in Chinese plasma donations is not available.
  
  
  RESULTS
  By using an in-house quantitative polymerase chain reaction (qPCR) assay adapted for all three genotypes of B19V, 235 source plasma pools from three regional different Chinese manufacturers of blood products were screened and quantified. Results showed that 71.91 % (169/235) of plasma pools were contaminated by B19V, with the concentrations of 5.18 × 10(2)-1.05 × 10(9) IU/mL. Approximately 31.95 % of the DNA-positive plasma pools were only moderately contaminated (<10(4) IU/mL), while 68.05 % contained >10(4) IU/mL.
  
  
  CONCLUSIONS
  The high level of B19V in plasma pools could present a great risk in plasma derivatives. Therefore, the implementation of B19V NAT (Nucleic Acid Testing) assays capable of detecting all B19V genotypes and discard donations with high titer B19V DNA for Chinese blood products manufacturers seems to be necessary.
authors.affiliation: Laboratory for Viral Safety of National Centre of Biomedical Analysis, Beijing Institute of Transfusion Medicine, No. 27 Taiping road, Haidian District, Beijing, 100850, China. junting1006@163.com.
authors.forename: Junting
authors.initials: J
authors.lastname: Jia
authors.affiliation: Laboratory for Viral Safety of National Centre of Biomedical Analysis, Beijing Institute of Transfusion Medicine, No. 27 Taiping road, Haidian District, Beijing, 100850, China. mayuyuan07@hotmail.com.
authors.forename: Yuyuan
authors.initials: Y
authors.lastname: Ma
authors.affiliation: Laboratory for Viral Safety of National Centre of Biomedical Analysis, Beijing Institute of Transfusion Medicine, No. 27 Taiping road, Haidian District, Beijing, 100850, China. zhaoxiong1980@126.com.
authors.forename: Xiong
authors.initials: X
authors.lastname: Zhao
authors.affiliation: Laboratory for Viral Safety of National Centre of Biomedical Analysis, Beijing Institute of Transfusion Medicine, No. 27 Taiping road, Haidian District, Beijing, 100850, China. guoyi1221@163.com.|Shaanxi Blood Center, Xi'an, China. guoyi1221@163.com.
authors.forename: Yi
authors.initials: Y
authors.lastname: Guo
authors.affiliation: Laboratory for Viral Safety of National Centre of Biomedical Analysis, Beijing Institute of Transfusion Medicine, No. 27 Taiping road, Haidian District, Beijing, 100850, China. hfcj0817@sina.com.
authors.forename: Chaoji
authors.initials: C
authors.lastname: Huangfu
authors.affiliation: Laboratory for Viral Safety of National Centre of Biomedical Analysis, Beijing Institute of Transfusion Medicine, No. 27 Taiping road, Haidian District, Beijing, 100850, China. famorby@126.com.
authors.forename: Chi
authors.initials: C
authors.lastname: Fang
authors.affiliation: Laboratory for Viral Safety of National Centre of Biomedical Analysis, Beijing Institute of Transfusion Medicine, No. 27 Taiping road, Haidian District, Beijing, 100850, China. fanrui028@163.com.
authors.forename: Rui
authors.initials: R
authors.lastname: Fan
authors.affiliation: Laboratory for Viral Safety of National Centre of Biomedical Analysis, Beijing Institute of Transfusion Medicine, No. 27 Taiping road, Haidian District, Beijing, 100850, China. maominlv@126.com.
authors.forename: Maomin
authors.initials: M
authors.lastname: Lv
authors.affiliation: Laboratory for Viral Safety of National Centre of Biomedical Analysis, Beijing Institute of Transfusion Medicine, No. 27 Taiping road, Haidian District, Beijing, 100850, China. yinyin1288@sina.com.
authors.forename: Huiqiong
authors.initials: H
authors.lastname: Yin
authors.affiliation: Laboratory for Viral Safety of National Centre of Biomedical Analysis, Beijing Institute of Transfusion Medicine, No. 27 Taiping road, Haidian District, Beijing, 100850, China. zhangjg@nic.bmi.ac.cn.
authors.forename: Jingang
authors.initials: J
authors.lastname: Zhang
mesh_terms: D001782:Blood Donors; D002681:China; D006801:Humans; D016732:Parvovirus B19, Human / Q000302:isolation & purification*; D010949:Plasma / Q000821:virology*; D015995:Prevalence; D012367:RNA, Viral / Q000235:genetics / Q000302:isolation & purification; D060888:Real-Time Polymerase Chain Reaction; D019562:Viral Load
chemical_list: D012367:RNA, Viral