New Strategies for Blood Donor Screening for Hepatitis B Virus
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INFECTIOUS DISEASES
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New Strategies for Blood Donor Screening for Hepatitis B Virus Nucleic Acid Testing versus Immunoassay Methods Mary C. Kuhns1 and Michael P. Busch2,3 1 2 3
Abbott Diagnostics, Abbott Park, Illinois, USA Blood Systems Research Institute, San Francisco, California, USA University of California, San Francisco, California, USA
Contents Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 1. Current Risk of Transfusion-Transmitted Hepatitis B Virus (HBV) without Nucleic Acid Testing (NAT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 2. Assay Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 2.1 HBV Surface Antigen (HBsAg) and Antibody to HBV Core Antigen (Anti-HBc) Immunoassays . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 2.2 HBV NAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 3. Model-Derived Estimates of the Impact of Increased Sensitivity HBsAg Assays or HBV NAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 3.1 Early Window Period Closure Based on Seroconversion Series . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 3.2 Viral Load at HBsAg Assay Detection Limits and Early Window Period Kinetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 4. Observed Yields of Increased Sensitivity HBsAg Assays and HBV NAT in Studies of Blood Donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 5. HBV DNA Detection in HBsAg-Negative, Anti-HBc-Positive Blood Donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 6. HBsAg-Positive Carriers with Low-Level or Negative HBV DNA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 7. Conclusions and Future Perspectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Abstract
Serologic testing for hepatitis B virus (HBV) surface antigen (HBsAg) and antibody to HBV core antigen (anti-HBc) has historically been the foundation of blood screening, while HBV nucleic acid testing (NAT) was recently developed to detect HBsAg-negative, anti-HBc-negative blood units donated during early acute infection. Comparison data on seroconversion panels using HBsAg assays of varying sensitivities and
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