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Routine screening of blood donations at Q ingdao central blood bank, C hina, 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
Author(s) -
Yang Zhongsi,
Xu Lei,
Liu Li,
Feng Qiuxia,
Zhang Longmu,
Ma Weijuan,
Saldanha John,
Wang Mingmin,
Zhao Lin
Publication year - 2013
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/trf.12159
Subject(s) - hbsag , hepatitis b virus , virology , orthohepadnavirus , hepadnaviridae , antigen , microbiology and biotechnology , hepatitis b , viral load , antibody , immunoassay , medicine , serology , nat , immunology , virus , biology , computer network , computer science
Background The R oche cobas T aq S creen 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 J une 2010 to J anuary 2011 in Q ingdao, C hina. Study Design and Methods HBsAg ‐negative samples from 65,800 voluntary blood donors were tested with the cobas T aq S creen MPX test in pools of 6 on the R oche cobas s 201 blood screening platform. Samples positive for HBV DNA and negative for HBsAg were quantitated with the R oche COBAS A mpli P rep/ COBAS T aq M an 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 R oche 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. Conclusion The HBV NAT yield in blood donors in Q ingdao is 0.06% (38/65,800). This study confirmed the value of NAT for interdicting HBV ‐positive donations and preventing transfusion‐transmitted HBV infections.