LZ was supported by the Chinese Ministry of Health Special Fund for Public Welfare (No. 201002005) for this study.
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
Article first published online: 11 MAR 2013
© 2013 American Association of Blood Banks
Special Issue: Thirty Years of Progress since Recognition of Transfusion-Associated AIDS
Volume 53, Issue 10pt2, pages 2538–2544, October 2013
How to Cite
Yang, Z., Xu, L., Liu, L., Feng, Q., Zhang, L., Ma, W., Saldanha, J., Wang, M. and Zhao, L. (2013), 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. Transfusion, 53: 2538–2544. doi: 10.1111/trf.12159
- Issue published online: 4 OCT 2013
- Article first published online: 11 MAR 2013
- Manuscript Accepted: 12 JAN 2013
- Manuscript Revised: 4 JAN 2013
- Manuscript Received: 9 NOV 2012
- Chinese Ministry of Health Special Fund for Public Welfare. Grant Number: 201002005
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.
Study Design and 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.
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.
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.