title: Blood donation screening for hepatitis B virus markers in the era of nucleic acid testing: are all tests of value?
abstract: BACKGROUND
  The American Red Cross implemented hepatitis B virus (HBV) minipool (MP)-nucleic acid testing (NAT) in June 2009, in addition to existing tests for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis B core antigen (anti-HBc). The value of all three tests was evaluated.
  
  
  METHODS
  HBsAg, anti-HBc, and HBV DNA (Ultrio MP-NAT, Gen-Probe/Novartis) donation results were analyzed during a 12-month period (July 1, 2009-June 30, 2010). Additional testing by individual-donation (ID) polymerase chain reaction (PCR) to confirm donor infection was performed when any HBV screening test was reactive or positive, except in the case of HBsAg neutralization-positive, anti-HBc-reactive samples. Numbers of blood donations identified as reactive or positive versus nonreactive or negative were compared.
  
  
  RESULTS
  Of about 6.5 million donations, 699 were defined as from HBV-infected donors, of which 64% (444) were reactive for all three markers. More than 99% (697) had reactivity to one or both serologic tests with 68% (477) showing reactivity by MP-NAT. Only two donations were DNA-positive, seronegative NAT-yield donations (1 per 3.23 million), fewer than expected (p = 0.0075). Among MP-NAT-reactive donors, only small numbers represented early infection (2 or 0.4% with negative serology and 10 or 2.1% who were HBsAg confirmed positive, anti-HBc nonreactive). Of the 142 occult HBV-infected donors, 85% were MP-NAT nonreactive requiring ID-PCR for detection (121 or 54.5% of all MP-NAT nonreactives vs. 21 or 4.4% of all MP-NAT reactives).
  
  
  CONCLUSIONS
  The HBV DNA-positive yield rate from MP-NAT was lower than expected, likely representing the rarity of such findings even in very large studies. With the implementation of HBV MP-NAT, the value of maintaining anti-HBc for the detection of low-level HBV DNA-positive donors was confirmed; however, HBsAg screening showed no blood safety value.
authors.affiliation: Scientific Support Office, American Red Cross, Gaithersburg, Maryland 20877, USA. stramers@usa.redcross.org
authors.forename: Susan L
authors.initials: SL
authors.lastname: Stramer
authors.forename: Shimian
authors.initials: S
authors.lastname: Zou
authors.forename: Edward P
authors.initials: EP
authors.lastname: Notari
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Foster
authors.forename: David E
authors.initials: DE
authors.lastname: Krysztof
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Musavi
authors.forename: Roger Y
authors.initials: RY
authors.lastname: Dodd
mesh_terms: D000465:Algorithms; D001782:Blood Donors; D058731:Blood Safety; D004279:DNA, Viral / Q000032:analysis / Q000302:isolation & purification; D005189:False Positive Reactions; D005819:Genetic Markers / Q000235:genetics; D006509:Hepatitis B / Q000097:blood* / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood; D006512:Hepatitis B Core Antigens / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D006515:Hepatitis B virus / Q000235:genetics* / Q000302:isolation & purification; D006801:Humans; D008403:Mass Screening / Q000379:methods* / Q000592:standards; D021141:Nucleic Acid Amplification Techniques / Q000379:methods* / Q000592:standards; D011237:Predictive Value of Tests; D016036:Seroepidemiologic Studies
chemical_list: D004279:DNA, Viral; D005819:Genetic Markers; D006510:Hepatitis B Antibodies; D006512:Hepatitis B Core Antigens; D006514:Hepatitis B Surface Antigens