title: Performance of HBsAg point-of-care tests for detection of diagnostic escape-variants in clinical samples.
abstract: BACKGROUND
  Hepatitis B viruses (HBV) harboring mutations in the a-determinant of the Hepatitis B surface antigen (HBsAg) are associated with reduced reactivity of HBsAg assays.
  
  
  OBJECTIVE
  To evaluate the sensitivity and specificity of three HBsAg point-of-care tests for the detection of HBsAg of viruses harboring HBsAg mutations.
  
  
  METHODS
  A selection of 50 clinical plasma samples containing HBV with HBsAg mutations was used to evaluate the performance of three HBsAg point-of-care tests (Vikia(®), bioMérieux, Marcy-L'Étoile, France. Alere Determine HBsAg™, Iverness Biomedical Innovations, Köln, Germany. Quick Profile™, LumiQuick Diagnostics, California, USA) and compared to the ARCHITECT HBsAg Qualitative(®) assay (Abbott Laboratories, Sligo, Ireland).
  
  
  RESULTS
  The sensitivity of the point-of-care tests ranged from 98% to 100%. The only false-negative result occurred using the Quick Profile™ assay with a virus harboring a D144A mutation.
  
  
  CONCLUSIONS
  The evaluated point-of-care tests revealed an excellent sensitivity in detecting HBV samples harboring HBsAg mutations.
authors.affiliation: Department of Infectious Diseases, Bern University Hospital and University of Bern, Switzerland. Electronic address: cedric.hirzel@insel.ch.
authors.forename: Cédric
authors.initials: C
authors.lastname: Hirzel
authors.affiliation: Institute for Infectious Diseases, University of Bern, Bern, Switzerland.
authors.forename: Stefan
authors.initials: S
authors.lastname: Pfister
authors.affiliation: Institute for Infectious Diseases, University of Bern, Bern, Switzerland.
authors.forename: Meri
authors.initials: M
authors.lastname: Gorgievski-Hrisoho
authors.affiliation: Department of Infectious Diseases, Bern University Hospital and University of Bern, Switzerland; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
authors.forename: Gilles
authors.initials: G
authors.lastname: Wandeler
authors.affiliation: Institute for Infectious Diseases, University of Bern, Bern, Switzerland.
authors.forename: Samuel
authors.initials: S
authors.lastname: Zuercher
mesh_terms: D004279:DNA, Viral / Q000235:genetics; D005188:False Negative Reactions; D005602:France; D006509:Hepatitis B / Q000175:diagnosis* / Q000821:virology*; D006514:Hepatitis B Surface Antigens / Q000032:analysis / Q000097:blood* / Q000235:genetics*; D006515:Hepatitis B virus / Q000235:genetics; D006801:Humans; D009154:Mutation; D019095:Point-of-Care Systems / Q000592:standards*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000592:standards
chemical_list: D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic
keywords: Background; Diagnostic-escape variants; Hbsag mutations; Hepatitis B virus; Point-of-care test