1. Anti-HBc screening of blood donors: a comparison of nine anti-HBc tests
- Author
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C.M. Nübling, Michael Schmidt, L. A. Walch, M. K. Hourfar, Michael Chudy, Erhard Seifried, W. K. Roth, and Heinrich Scheiblauer
- Subjects
HBsAg ,viruses ,Hepatitis C virus ,Blood Donors ,medicine.disease_cause ,Sensitivity and Specificity ,Antigen ,Germany ,parasitic diseases ,medicine ,Humans ,Mass Screening ,Hepatitis B virus ,Hepatitis B Surface Antigens ,biology ,business.industry ,Blood Screening ,virus diseases ,Hematology ,General Medicine ,Hepatitis B ,Viral Load ,medicine.disease ,Virology ,Hepatitis B Core Antigens ,digestive system diseases ,Immunology ,biology.protein ,Antibody ,business ,Viral load ,Nucleic Acid Amplification Techniques - Abstract
Background and Objectives Since voluntary introduction of hepatitis B virus (HBV) minipool nucleic acid amplification technology (NAT) at the German Red Cross, the expected residual risk of a transfusion-associated HBV infection has been estimated to be 1 : 500 000 – about 10 times higher than for human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection. Donors demonstrating chronic positivity for antibody to hepatitis B core antigen (anti-HBc), negativity for hepatitis B surface antigen (HBsAg) and polymerase chain reaction (PCR)-negative with a low virus load are a major cause of this increased risk. Materials and Methods Ten-thousand blood donors from our blood-donation centre were screened for anti-HBc using the current PRISM® HBc and the new PRISM® HBcore assay to evaluate the diagnostic sensitivity and specificity of these tests. PRISM® HBc- or PRISM® HBcore-reactive samples were further analysed using seven additional tests for anti-HBc, two tests for antibody to hepatitis B surface antigen (anti-HBs), one test for antibody to hepatitis B envelope antigen (anti-HBe) and three HBV NAT assays. Results From a total of 10 000 donors, nine and 14 samples were reactive only in the PRISM® HBc and the PRISM® HBcore, respectively, whereas 165 samples were reactive in both anti-HBc assays. Further analysis of these 188 anti-HBc-reactive specimens in a total of nine different anti-HBc assays revealed concordant results for 162 (86·2%) specimens. Sample cut-off values for anti-HBc were significantly (P
- Published
- 2006