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Hepatitis B virus nucleic acid testing in Chinese blood donors with normal and elevated alanine aminotransferase
Author(s) -
Ren FuRong,
Wang JingXing,
Huang Yi,
Yao FuZhu,
Lv YunLai,
Li JuLin,
Wen GuoXin,
Wen XiuQiong,
Liu Jiang,
Dong XiangDong,
Ma HongLi,
Zhou ZhongMin,
Bi XinHong,
Tu Lin,
King Melissa,
Nelson Kenrad,
Ness Paul,
Shan Hua
Publication year - 2011
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2011.03215.x
Subject(s) - nat , hepatitis b virus , medicine , window period , virology , serology , viral load , transmission (telecommunications) , nucleic acid test , hepatitis b , residual risk , immunology , antibody , virus , disease , covid-19 , infectious disease (medical specialty) , computer network , computer science , electrical engineering , engineering
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. STUDY DESIGN AND 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.