title: Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France.
abstract: OBJECTIVE
  The systematic use of rapid tests performed at points-of-care may facilitate hepatitis B virus (HBV) screening and substantially increase HBV infection awareness. The aim of this study was to evaluate the effectiveness of such tests for HBsAg and anti-HBsAb detection among individuals visiting a variety of healthcare centers located in a low HBV-prevalent area.
  
  
  METHODS
  Three rapid tests for hepatitis B surface antigen (HBsAg) detection (VIKIA, Determine and Quick Profile) and one test for anti-hepatitis B surface antibody (anti-HBsAb) detection (Quick Profile) were evaluated in comparison to ELISA serology. Sensitivity (Se), specificity (Sp), positive and negative predictive values (PPV and NPV, respectively) and area under the ROC curve were used to estimate test performance. Non-inferiority criteria of the joint Se, Sp were set at 0.80, 0.95.
  
  
  RESULTS
  Among the 3956 subjects screened, 85 (2.1%) were HBsAg-positive and 2225 (56.5%) had a protective anti-HBsAb titer. Test Se and Sp (lower bound of 97.5% CI) were as follows: 96.5% (89.0%), 99.9% (99.8%) for Vikia; 93.6% (80.7%), 100.0% (99.8%) for Determine; and 90.5% (80.8%), 99.7% (99.5%) for Quick Profile; with all three tests achieving minimal non-inferiority criteria. False negatives were typically observed in inactive HBsAg carriers. The anti-HBsAb Quick Profile test had excellent specificity (97.8%) and PPV (97.8%) albeit low sensitivity (58.3%), thus failing to establish non-inferiority.
  
  
  CONCLUSIONS
  All three HBsAg rapid tests could be considered ideal for HBV screening in low HBV-prevalent countries, given the ease of use, rapidity, and high classification probabilities. The anti-HBsAb Quick Profile could be considered reliable only for positive tests.
authors.affiliation: Inserm UMR-S707, Paris, France. julie.bottero@sat.aphp.fr
authors.forename: Julie
authors.initials: J
authors.lastname: Bottero
authors.forename: Anders
authors.initials: A
authors.lastname: Boyd
authors.forename: Joel
authors.initials: J
authors.lastname: Gozlan
authors.forename: Maud
authors.initials: M
authors.lastname: Lemoine
authors.forename: Fabrice
authors.initials: F
authors.lastname: Carrat
authors.forename: Anne
authors.initials: A
authors.lastname: Collignon
authors.forename: Nicolas
authors.initials: N
authors.lastname: Boo
authors.forename: Philippe
authors.initials: P
authors.lastname: Dhotte
authors.forename: Brigitte
authors.initials: B
authors.lastname: Varsat
authors.forename: Gérard
authors.initials: G
authors.lastname: Muller
authors.forename: Olivier
authors.initials: O
authors.lastname: Cha
authors.forename: Odile
authors.initials: O
authors.lastname: Picard
authors.forename: Jean
authors.initials: J
authors.lastname: Nau
authors.forename: Pauline
authors.initials: P
authors.lastname: Campa
authors.forename: Benjamin
authors.initials: B
authors.lastname: Silbermann
authors.forename: Marc
authors.initials: M
authors.lastname: Bary
authors.forename: Pierre-Marie
authors.initials: PM
authors.lastname: Girard
authors.forename: Karine
authors.initials: K
authors.lastname: Lacombe
mesh_terms: D015331:Cohort Studies; D003951:Diagnostic Errors; D005602:France; D006510:Hepatitis B Antibodies / Q000097:blood*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006515:Hepatitis B virus / Q000302:isolation & purification*; D006801:Humans
chemical_list: D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens