title: Routine screening of blood donations at Qingdao central blood bank, China, for hepatitis B virus (HBV) DNA with a real-time, multiplex nucleic acid test for HBV, hepatitis C virus, and human immunodeficiency virus Types 1 and 2.
abstract: BACKGROUND
  The Roche cobas TaqScreen MPX test was used to evaluate the rate of hepatitis B surface antigen (HBsAg)-negative donations that were hepatitis B virus (HBV) DNA reactive from June 2010 to January 2011 in Qingdao, China.
  
  
  METHODS
  HBsAg-negative samples from 65,800 voluntary blood donors were tested with the cobas TaqScreen MPX test in pools of 6 on the Roche cobas s 201 blood screening platform. Samples positive for HBV DNA and negative for HBsAg were quantitated with the Roche COBAS AmpliPrep/COBAS TaqMan HBV test. In addition, serologic tests for HBsAg, hepatitis B surface antibody, anti-hepatitis B core antigen (anti-HBc), anti-hepatitis B e antigen (anti-HBe), and hepatitis B e antigen (HBe) were done using the Roche electrochemiluminescence immunoassay.
  
  
  RESULTS
  A total of 80 nucleic acid amplification technology (NAT) test-reactive pools were identified and 59 pools (74%) resolved to a reactive sample. All samples were HBV DNA reactive and the viral load in each sample was quantitated. The viral loads of the samples ranged from less than 20 to 34,600 IU/mL; 13 samples (22%) had viral loads of more than 20 IU/mL, 27 samples (45.8%) had viral loads of less than 20 IU/mL, and 19 samples (32.2%) had undetectable viral loads. Of the 59 NAT-reactive samples, 40 (67.8%) were anti-HBc positive. Fifteen of the 59 samples could not be confirmed as NAT reactive either by an alternative NAT test or by serology.
  
  
  CONCLUSIONS
  The HBV NAT yield in blood donors in Qingdao is 0.06% (38/65,800). This study confirmed the value of NAT for interdicting HBV-positive donations and preventing transfusion-transmitted HBV infections.
authors.affiliation: Qingdao Blood Centre, Qingdao, ShanDong Province, China; Roche Molecular Systems, Pleasanton, California.
authors.forename: Zhongsi
authors.initials: Z
authors.lastname: Yang
authors.forename: Lei
authors.initials: L
authors.lastname: Xu
authors.forename: Li
authors.initials: L
authors.lastname: Liu
authors.forename: Qiuxia
authors.initials: Q
authors.lastname: Feng
authors.forename: Longmu
authors.initials: L
authors.lastname: Zhang
authors.forename: Weijuan
authors.initials: W
authors.lastname: Ma
authors.forename: John
authors.initials: J
authors.lastname: Saldanha
authors.forename: Mingmin
authors.initials: M
authors.lastname: Wang
authors.forename: Lin
authors.initials: L
authors.lastname: Zhao
mesh_terms: D000328:Adult; D001771:Blood Banks; D001782:Blood Donors; D002681:China; D004279:DNA, Viral / Q000235:genetics / Q000302:isolation & purification; D015483:HIV Antibodies / Q000032:analysis / Q000097:blood; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D015498:HIV-2 / Q000235:genetics / Q000302:isolation & purification*; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006508:Hepatitis Antibodies / Q000032:analysis / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008403:Mass Screening / Q000379:methods / Q000706:statistics & numerical data; D008875:Middle Aged; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012698:Serologic Tests / Q000379:methods / Q000706:statistics & numerical data; D055815:Young Adult
chemical_list: D004279:DNA, Viral; D015483:HIV Antibodies; D006508:Hepatitis Antibodies