T R A N S F U S I O N C O M P L I C AT I O N S
Evaluation of a multiplex human immunodeficiency virus-1,
hepatitis C virus, and hepatitis B virus nucleic acid testing assay
to detect viremic blood donors in northern Thailand
Niwes Nantachit, Lakkana Thaikruea, Satawat Thongsawat, Nipapan Leetrakool,
Ladda Fongsatikul, Prakai Sompan, Yiu-Lian Fong, David Nichols, Rainer Ziermann,
Paul Ness, and Kenrad E. Nelson
BACKGROUND: Screening of blood donors with
nucleic acid testing (NAT) for human immunodeficiency
virus (HIV) and hepatitis C virus (HCV) has been imple-
mented recently in the United States. There are limited
data, however, on the additional NAT yield of donors in
developing countries in Asia where the prevalence of
infection is higher. In addition, data on hepatitis B virus
(HBV) NAT in high prevalence areas are minimal.
STUDY DESIGN AND METHODS: A total of 5083
whole-blood donors at the Chiang Mai University
Hospital, Thailand, blood bank were evaluated with
a commercially available NAT assay (Procleix Ultrio,
Gen-Probe, Inc.) to screen individual donations.
RESULTS: No NAT yield cases were found for HIV-1 or
HCV. There were 17 samples with discrepant HBV DNA
NAT and hepatitis B surface antigen (HBsAg) tests,
however. Seven of these were HBV DNA NAT–positive,
HBsAg-negative; of these 7, 1 was NAT-positive at
baseline, but negative on follow-up, and considered
a false-positive, 1 had an acute infection, and 5 had
chronic prevalent HBV infections, for a NAT yield of 6 in
4798 HBsAg negative donors (1:800). In addition there
were 10 NAT-negative, HBsAg-positive serum samples.
All were anti-hepatitis B core antigen immunoglobulin
G–positive; on testing with a more sensitive NAT target
capture assay, 5 were positive (1.8-20.6 IU/mL) and 5
were negative.
CONCLUSION: Multiplex NAT screening of individual-
donor serum samples in Northern Thailand detected
approximately 1 per 800 HBV NAT–positive, HBsAg-
negative donors. The especially high prevalence of
HBV infection in Thailand and other Asian countries
suggests that HBV NAT screening of donors will be
more cost-effective than in other areas.
S
creening of blood donors to minimize the risk of
transfusion-transmitted infections has relied pri-
marily on serologic testing to detect viral anti-
bodies or antigens until recently. In the past few
years, however, nucleic acid testing (NAT) has been imple-
mented to detect donors infected with human immuno-
deficiency virus (HIV)-1, hepatitis C virus (HCV), or West
Nile virus, who are in the window period before develop-
ing an antibody response or who have immunosilent
infections.1-5 Generally the initial screening with NAT
assays has involved testing minipools of donor plasma
samples and then resolving the reactive pool to the indi-
vidual positive specimen and the specific viral nucleic
acid by testing smaller pools and then individual samples.
In the United States, NAT assays have included the
routine detection of HIV, HCV, and West Nile virus among
blood donors.1,4,5 In several European countries, multiplex
NAT assays also have included probes to detect hepatitis B
virus (HBV).6,7 In several Asian countries, including Thai-
land, two multiplex NAT assays are available that include
probes and primers to detect HBV.
Because of economic and technologic limitations,
NAT assays have not been used frequently for routine
donor screening in developing countries. There is also a
From the Faculty of Medicine, Chiang Mai University, Chiang
Mai, Thailand; Chiron, Novartis Vaccines and Diagnostics,
Emeryville, California; and the Johns Hopkins University,
Baltimore, Maryland.
Address reprint requests to: Kenrad E. Nelson, Department
of Epidemiology, Johns Hopkins University, 615 N. Wolfe Street,
Baltimore, MD, 21205; e-mail: kenelson@jhsph.edu.
The research was supported in part by Grant
5U01DA13032-5 from the National Institutes of Health,
Bethesda, MD.
Received for publication February 23, 2007; revision
received March 26, 2007, and accepted March 27, 2007.
doi: 10.1111/j.1537-2995.2007.01395.x
TRANSFUSION 2007;47:1803-1808.
Volume 47, October 2007 TRANSFUSION 1803