title: Sensitivity and specificity of Anti-HBc screening assays--which assay is best for blood donor screening?
abstract: Compared to HIV and hepatitis C virus, the residual infectious risk of hepatitis B virus (HBV) posed by blood products is about 10 times higher. In addition to HBsAg testing, screening for anti-HBc was recommended by the German Advisory Committee Blood in March 2005. Prevalence of anti-HBc in German blood donors was investigated at five test sites located in different geographic regions. In total, 12,000 blood donors were screened for anti-HBc by PRISM HBcore, and a statistically representative number of these were tested with Abbott Murex anti-HBc total, bioMérieux Hepanostika anti-HBc uniform, Bio-Rad Monolisa anti-HBc PLUS and Dade Behring Enzygnost anti-HBc. Anti-HBc repeat reactive samples were tested for anti-HBs, anti-HBe and HBV DNA by individual donation NAT. The mean prevalence of anti-HBc was 1.75% in donors that had not been tested for anti-HBc in the past. The percentage of anti-HBs in anti-HBc repeat reactive donors was 93.7%. Samples that were additionally reactive for anti-HBe were anti-HBc reactive in all tested assays. The sample to cut-off (S/Co) values for anti-HBc were lower (competitive assays) in samples that were also positive for anti-HBe, when compared to samples that were only anti-HBc reactive. Most commercially available anti-HBc assays provide sufficient sensitivity for routine screening purposes, and lacking specificity is no longer a serious issue for most of them. Assay differences were recognized for samples that were anti-HBc only reactive. The overall loss of 1.75% of positive testing donors can be significantly reduced to 0.45% by implementation of re-entry procedures for donors with an anti-HBs titre of over 100 IU/l and negative by sensitive ID-NAT.
authors.affiliation: Institute of Transfusion Medicine and Immunohematology, German Red Cross, Johann Wolfgang Goethe University, Frankfurt, Germany.
authors.forename: M K
authors.initials: MK
authors.lastname: Hourfar
authors.forename: L A
authors.initials: LA
authors.lastname: Walch
authors.forename: G
authors.initials: G
authors.lastname: Geusendam
authors.forename: T
authors.initials: T
authors.lastname: Dengler
authors.forename: K
authors.initials: K
authors.lastname: Janetzko
authors.forename: K
authors.initials: K
authors.lastname: Gubbe
authors.forename: K
authors.initials: K
authors.lastname: Frank
authors.forename: A
authors.initials: A
authors.lastname: Karl
authors.forename: M
authors.initials: M
authors.lastname: Löhr
authors.forename: W
authors.initials: W
authors.lastname: Sireis
authors.forename: E
authors.initials: E
authors.lastname: Seifried
authors.forename: M
authors.initials: M
authors.lastname: Schmidt
mesh_terms: D001782:Blood Donors; D003140:Communicable Disease Control; D004279:DNA, Viral / Q000097:blood; D046148:Donor Selection; D005858:Germany / Q000453:epidemiology; D006509:Hepatitis B / Q000097:blood / Q000453:epidemiology; D006510:Hepatitis B Antibodies / Q000097:blood; D006512:Hepatitis B Core Antigens / Q000032:analysis / Q000276:immunology*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000276:immunology*; D006801:Humans; D012680:Sensitivity and Specificity
chemical_list: D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006512:Hepatitis B Core Antigens; D006514:Hepatitis B Surface Antigens