title: Evaluation of an individual-donation nucleic acid amplification testing algorithm for detecting hepatitis B virus infection in Chinese blood donors.
abstract: BACKGROUND
  This multicenter study was performed to evaluate the efficiency of a multiplex individual-donation nucleic acid amplification technology (ID-NAT) and discriminatory testing algorithm for detecting hepatitis B virus (HBV) infection in Chinese blood donors.
  
  
  METHODS
  A total of 1,205,796 hepatitis B surface antigen (HBsAg)-nonreactive donations from 10 blood centers were tested by ID-NAT using the Ultrio assay. Multiplex Ultrio-reactive donations were tested in the discriminatory tests as well as in quantitative polymerase chain reaction (qPCR) and in supplemental electrochemiluminescence immunoassays for HBsAg, hepatitis B surface antibody (anti-HBs), hepatitis B e antigen, and antibody to hepatitis B core antigen (anti-HBc). Meanwhile, a control group of 4317 Ultrio-nonreactive donations was tested for anti-HBc and anti-HBs.
  
  
  RESULTS
  Of all donations, 2033 (0.17%) were reactive in the multiplex Ultrio assay. Among 1776 further tested samples, 548 (30.9%) were HBV discriminatory assay (dHBV)-reactive, while 1214 (68.4%) were nonreactive. Of 472 Ultrio+ and dHBV+ samples 86.2% were qPCR positive compared to 15.0% in 1046 Ultrio+ and dHBV- samples. The proportion of anti-HBc+ and anti-HBs- (potentially infectious) donations was higher in 409 Ultrio+ and dHBV+ than in 1028 Ultrio+ and dHBV- samples (51.3% vs. 31.1%, p < 0.001). The yield rate of Ultrio+, dHBV+, and qPCR+ donations was estimated at 1 in 2500, but at 1 in 1100 when all supplemental tests were taken into account assuming that 44% of detected donations by Ultrio were false reactive.
  
  
  CONCLUSIONS
  A quarter of HBsAg-negative Ultrio+ and dHBV- donations in China are likely given by potentially infectious low-viral-load occult carriers. Although this has no implication for blood safety, the testing algorithm needs to be redesigned to more efficiently discriminate between true and false NAT reactivity.
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing.|Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing.
authors.forename: Hongna
authors.initials: H
authors.lastname: Gou
authors.affiliation: Institute for Infectious Disease and Endemic Disease Control, Beijing Center for Disease Prevention and Control (CDC), Beijing.
authors.forename: Yang
authors.initials: Y
authors.lastname: Pan
authors.affiliation: Beijing Blood Center, Beijing, China.
authors.forename: Hongwei
authors.initials: H
authors.lastname: Ge
authors.affiliation: Guangzhou Blood Center, Guangzhou, China.
authors.forename: Yourong
authors.initials: Y
authors.lastname: Zheng
authors.affiliation: Zhejiang Blood Center, Zhejiang, China.
authors.forename: Yaling
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Shenzhen Blood Center, Shenzhen, China.
authors.forename: Jinfeng
authors.initials: J
authors.lastname: Zeng
authors.affiliation: Qingdao Blood Center, Qingdao, China.
authors.forename: Zhongsi
authors.initials: Z
authors.lastname: Yang
authors.affiliation: Tianjin Blood Center, Tianjin, China.
authors.forename: Tong
authors.initials: T
authors.lastname: Pan
authors.affiliation: Kunming Blood Center, Kunming, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Cun
authors.affiliation: Shanghai Blood Center, Shanghai, China.
authors.forename: Guoping
authors.initials: G
authors.lastname: Zhou
authors.affiliation: Neimenggu Blood Center, Neimenggu, China.
authors.forename: Gen
authors.initials: G
authors.lastname: Fang
authors.affiliation: Tongzhou Blood Center, Beijing, China.
authors.forename: Jiahong
authors.initials: J
authors.lastname: Zhang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing.
authors.forename: Kuo
authors.initials: K
authors.lastname: Zhang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing.
authors.forename: Rui
authors.initials: R
authors.lastname: Zhang
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing.
authors.forename: Yu
authors.initials: Y
authors.lastname: Sun
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing.
authors.forename: Jiehong
authors.initials: J
authors.lastname: Xie
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing.
authors.forename: Jinming
authors.initials: J
authors.lastname: Li
authors.affiliation: National Center for Clinical Laboratories, Beijing Hospital, Beijing.
authors.forename: Lunan
authors.initials: L
authors.lastname: Wang
mesh_terms: D000465:Algorithms; D044466:Asian People; D001782:Blood Donors; D002681:China; D046148:Donor Selection / Q000379:methods*; D005260:Female; D006509:Hepatitis B / Q000097:blood*; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus; D006801:Humans; D008297:Male; D012367:RNA, Viral / Q000097:blood*; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods* / Q000592:standards; D012680:Sensitivity and Specificity
chemical_list: D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D012367:RNA, Viral