title: A pilot study on screening blood donors with individual-donation nucleic acid testing in China.
abstract: BACKGROUND
  Nucleic acid amplification testing (NAT) is not yet obligatory in China for blood donor screening and the risk of enzyme immunoassay (EIA)-negative, NAT-reactive donations in Chinese blood donors has rarely been reported. The aim of this study was to screen a population of Chinese blood donors using a triplex individual-donation (ID)-NAT assay and assess the safety benefits of implementing NAT.
  
  
  METHODS
  Between 1st August, 2010 and 31st December, 2011 all donations at a Chinese blood centre were screened individually using the Procleix® Ultrio® assay, a multiplex NAT assay for the detection of hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) RNA and human immunodeficiency virus-1 (HIV-1) RNA. All donations were also screened for HBsAg, anti-HIV and anti-HCV using two different EIA for each marker. Samples with discordant results between NAT and EIA were further tested with an alternative NAT assay (Cobas® TaqMan®). Potential yield cases (serologically negative/NAT-reactive donors) were further evaluated when possible.
  
  
  RESULTS
  During the study period a total of 178,447 donations were screened by NAT and EIA, among which 169 HBV NAT yield cases (0.095%) were detected. No N AT yield cases were found for HIV-1 or HCV. For the HBV NAT yield cases, follow-up results showed that 11 (6.51%) were probable or confirmed HBV window period infections, 5 (2.96%) were chronic HBV carriers and 153 (90.53%) were probable or confirmed occult HBV infections. There was a statistically significant difference between the NAT-positive rates for first-time vs repeat donations (0.472% vs 0.146%, respectively; P<0.001).
  
  
  CONCLUSIONS
  Our data demonstrate that the potential HBV yield rate was 1:1,056 for blood donations in the Zhejiang province of China. Implementation of NAT will provide a significant increment in safety relative to serological screening alone.
authors: Blood Centre of Zhejiang Province, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China Key Laboratory of Blood Safety Research, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China.
authors: Jie
authors: J
authors: Dong
authors: Blood Centre of Zhejiang Province, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China Key Laboratory of Blood Safety Research, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China.
authors: Yaling
authors: Y
authors: Wu
authors: Blood Centre of Zhejiang Province, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China Key Laboratory of Blood Safety Research, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China.
authors: Hong
authors: H
authors: Zhu
authors: Blood Centre of Zhejiang Province, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China Key Laboratory of Blood Safety Research, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China.
authors: Gan
authors: G
authors: Li
authors: Blood Centre of Zhejiang Province, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China Key Laboratory of Blood Safety Research, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China.
authors: Mengen
authors: M
authors: Lv
authors: Blood Centre of Zhejiang Province, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China Key Laboratory of Blood Safety Research, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China.
authors: Daxiao
authors: D
authors: Wu
authors: Blood Centre of Zhejiang Province, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China Key Laboratory of Blood Safety Research, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China.
authors: Xiaotao
authors: X
authors: Li
authors: Blood Centre of Zhejiang Province, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China Key Laboratory of Blood Safety Research, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China.
authors: Faming
authors: F
authors: Zhu
authors: Blood Centre of Zhejiang Province, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China Key Laboratory of Blood Safety Research, Ministry of Health, Hangzhou, Zhejiang, People's Republic of China.
authors: Hangjun
authors: H
authors: Lv
mesh_terms: D001782:Blood Donors; D004279:DNA, Viral / Q000097:blood*; D046148:Donor Selection / Q000379:methods*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D021141:Nucleic Acid Amplification Techniques; D010865:Pilot Projects; D012367:RNA, Viral / Q000097:blood*; D014777:Virus Diseases / Q000097:blood / Q000517:prevention & control / Q000635:transmission; D014780:Viruses / Q000378:metabolism
chemical_list: D004279:DNA, Viral; D012367:RNA, Viral