title: Hepatitis B virus nucleic acid testing in Chinese blood donors with normal and elevated alanine aminotransferase.
abstract: BACKGROUND
  Nucleic acid testing (NAT) is currently not a routine donor test in China. The aim of this study was to evaluate the current residual risk of hepatitis B virus (HBV) transmission and the value of ALT testing in preventing HBV infection.
  
  
  METHODS
  From January 2008 to September 2009, a total of 5521 qualified donations by routine screening and 5034 deferred donations due to elevated ALT alone were collected from five blood centers. Samples were tested for HBV DNA by triplex individual-donation (ID)-NAT (ULTRIO assay, on the TIGRIS system, Novartis Diagnostics). HBV NAT-reactive samples were further analyzed by HBV serology, alternative NAT, and viral load and were diluted to simulate if they could be detected in a minipool-NAT.
  
  
  RESULTS
  There was no significant difference in the HBV NAT-yield rate between the qualified donations group (5/5521) and the deferred donations group (4/5034). Of these nine potential HBV-yield cases, one donor (11%) was a possible HBV window-period donor, one (11%) was a chronic HBV carrier, and seven (78%) had probable or confirmed occult HBV infections. Of seven potential HBV-yield cases quantified, the viral loads were less than or equal to 70.0 IU/mL. Minipool testing (minipools of 4, 8, and 16 donations) would miss 43% to 79% of the nine HBV-yield donations.
  
  
  CONCLUSIONS
  Based on our findings in qualified donations, we estimate that the nationwide implementation of ID-NAT testing for HBV DNA in China would detect an additional 9964 viremic donations per year. ALT testing seems to have no significant value in preventing transfusion-transmitted HBV infection. ID-NAT versus simulated minipool-NAT using the ULTRIO test demonstrates the benefit to implement a more sensitive NAT strategy in regions of high HBV endemicity.
authors.affiliation: Beijing Red Cross Blood Center, Beijing, China.
authors.forename: Fu-Rong
authors.initials: FR
authors.lastname: Ren
authors.forename: Jing-Xing
authors.initials: JX
authors.lastname: Wang
authors.forename: Yi
authors.initials: Y
authors.lastname: Huang
authors.forename: Fu-Zhu
authors.initials: FZ
authors.lastname: Yao
authors.forename: Yun-Lai
authors.initials: YL
authors.lastname: Lv
authors.forename: Ju-Lin
authors.initials: JL
authors.lastname: Li
authors.forename: Guo-Xin
authors.initials: GX
authors.lastname: Wen
authors.forename: Xiu-Qiong
authors.initials: XQ
authors.lastname: Wen
authors.forename: Jiang
authors.initials: J
authors.lastname: Liu
authors.forename: Xiang-Dong
authors.initials: XD
authors.lastname: Dong
authors.forename: Hong-Li
authors.initials: HL
authors.lastname: Ma
authors.forename: Zhong-Min
authors.initials: ZM
authors.lastname: Zhou
authors.forename: Xin-Hong
authors.initials: XH
authors.lastname: Bi
authors.forename: Lin
authors.initials: L
authors.lastname: Tu
authors.forename: Melissa
authors.initials: M
authors.lastname: King
authors.forename: Kenrad
authors.initials: K
authors.lastname: Nelson
authors.forename: Paul
authors.initials: P
authors.lastname: Ness
authors.forename: Hua
authors.initials: H
authors.lastname: Shan
mesh_terms: D000410:Alanine Transaminase / Q000097:blood*; D044466:Asian People; D001782:Blood Donors; D002681:China; D004279:DNA, Viral / Q000097:blood*; D046148:Donor Selection / Q000379:methods*; D005260:Female; D006509:Hepatitis B / Q000097:blood* / Q000517:prevention & control* / Q000635:transmission; D006515:Hepatitis B virus; D006801:Humans; D008297:Male; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D019562:Viral Load / Q000295:instrumentation / Q000379:methods
chemical_list: D004279:DNA, Viral; D000410:Alanine Transaminase