ChironResult_NAT_transfusion1007 1 | Hepatitis B | Hepatitis

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 implemented 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 individualdonor serum samples in Northern Thailand detected approximately 1 per 800 HBV NAT–positive, HBsAgnegative 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.

creening of blood donors to minimize the risk of transfusion-transmitted infections has relied primarily on serologic testing to detect viral antibodies or antigens until recently. In the past few years, however, nucleic acid testing (NAT) has been implemented to detect donors infected with human immunodeficiency virus (HIV)-1, hepatitis C virus (HCV), or West Nile virus, who are in the window period before developing 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 individual 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 Thailand, 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

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