Comparison of hepatitis B, core, HBc, and hepatitis B antibody, anti HBs, in a presumed low risk donor population
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ORIGINAL PAPER
Comparison of hepatitis B, core, HBc, and hepatitis B antibody, anti HBs, in a presumed low risk donor population Ellen Heck • H. Dwight Cavanagh
Received: 6 August 2013 / Accepted: 15 November 2013 Ó Springer Science+Business Media Dordrecht 2013
Abstract Donors screened by medical social history interview negative for high risk behavior or communicable disease history, but subsequently exhibiting reactive serological markers, emphasize importance of duel safe guarding factors for determining donor suitability. This report examines a relationship between two immunoabsorption assay tests, hepatitis B core (HBc) antibody, a required food and drug administration (FDA) test, and hepatitis B antibody (anti HBs), non-required test. Reactive serology results, 129 cases, 3,581 donors (2008–2012) for HBc as the only initially positive serological marker were subjected to anti HBs testing in this history prescreened donor population. Enzyme linked immunoabsorption assay kits hepatitis B, core and antibody, were used in this study. All samples were initially tested for human immunodeficiency virus, hepatitis B, and hepatitis C, utilizing nucleic acid testing and antigen antibody immunoabsorption assay. Testing was performed by a FDA-registered CLEA-certified reference laboratory. Samples were deceased donor blood samples and a limited number of pre-mortem samples, separated, stored and analyzed according to manufacturer recommendation and FDA regulations. E. Heck (&) H. D. Cavanagh Transplant Services Center, University of Texas Southwestern Medical Center, Dallas, TX, USA e-mail: [email protected] H. D. Cavanagh e-mail: [email protected]
129 reactive HBc only samples, were subsequently tested for anti HBs. Of these 129, 94 were found to be reactive for anti HBs. This represented 72 % of samples tested for antibody, a higher percentage than anticipated for a medical history negative, low risk population. Keywords Hepatitis B Antibody Core Allograft safety Abbreviations HIV Human immunodeficiency virus (HIV-1, HIV-2) HBV Hepatitis B virus HBc Hepatitis B core HCV Hepatitis C virus NAT Nucleic acid testing CDC Centers for disease control FDA Food and drug administration
Introduction Donor allograft safety and the possibility of communicable disease transmission is a continuing concern for eye, tissue and organ procurement organizations. Since donors are pre-screened for risk factors both prior behavioral and disease, with a medical social history questionnaire and the resulting donor population is conventionally considered to be of low risk for communicable disease. Thus, a finding of hepatitis B
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core (HBc) only reactivity in samples which had been previously tested for all food and drug administration (FDA) required serologies(Food and Drug Administration 2001) has raised perplexing questions of clinical significance. Can these findings in a low risk population indicate a false-positive test reaction or are they indicative of a marker of recent or chronic hepatiti
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