title: Effectiveness of hepatitis B rapid tests toward linkage-to-care: results of a randomized, multicenter study.
abstract: OBJECTIVE
  Worldwide, many infected individuals are unaware of their hepatitis B virus (HBV) status. We evaluated the effectiveness of HBV rapid testing in promoting linkage-to-care.
  
  
  METHODS
  In 2012, volunteers were recruited from five Parisian centers. Participants were randomized 1 : 1 to receive standard serology (S) or rapid testing (VIKIA-HBsAg/Quick Profile anti-HBsAb) with confirmatory serology (R+S). The primary endpoint was percentage of individuals with appropriate linkage-to-care (nonimmunized individuals starting vaccination or HBsAg-positive individuals receiving medical evaluation). The secondary outcomes were percentage receiving HBV-test results and performance of HBV rapid tests.
  
  
  RESULTS
  In total, 995 individuals were screened. Among the HBV-infection groups included in the primary endpoint (n=409), 20 (4.9%) received appropriate linkage-to-care, with no difference between S and R+S groups (5.7 vs. 4.1%, P=0.5). Two of eight HBsAg-positive participants had a medical visit (1/6 and 1/2 in the S and R+S groups, respectively) and 18/401 (4.5%) nonimmunized participants initiated HBV-vaccination (11/205 and 7/196). Factors that tended to be associated with linkage-to-care were female sex, birth country of high HBV prevalence, and extended medical stay. Test results were not obtained in 4.7% of participants, which was significantly higher in the S arm (P=0.02). Both sensitivity and specificity were 100% for the VIKIA-HBsAg rapid test and 94.4 and 80.8%, respectively, for the anti-HBsAb Quick Profile rapid test.
  
  
  CONCLUSIONS
  Despite a higher proportion of participants obtaining their results in the R+S arm and better performance of anti-HBsAb rapid tests than described previously, we found no evidence that HBV screening based initially on rapid tests leads to increased HBV-vaccination rates or medical evaluation. This strategy should be evaluated in more hard-to-reach populations.
authors.affiliation: aSorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP UMRS 1136) bDepartment of Virology, St Antoine Hospital, AP-HP cINSERM U1135 CIMI dDepartment of Public Health eDepartment of Hepatology, St Antoine Hospital, AP-HP fCaisse Primaire d'Assurance Maladie (CPAM), Département des Examens Périodiques de Santé de l'Adulte (DEPSA) gMairie de Paris, Direction de l'Action Sociale, de l'Enfance et de la Santé hMairie de Paris, Centre de dépistage anonyme et gratuit (CDAG) de Belleville iMairie de Paris, Laboratoire St Marcel jPoliclinique Baudelaire, St Antoine Hospital, AP-HP kMairie de Paris, CDAG du Figuier lDepartment of Infectious Diseases, St Antoine Hospital, AP-HP, Paris, France.
authors.forename: Julie
authors.initials: J
authors.lastname: Bottero
authors.forename: Anders
authors.initials: A
authors.lastname: Boyd
authors.forename: Joël
authors.initials: J
authors.lastname: Gozlan
authors.forename: Fabrice
authors.initials: F
authors.lastname: Carrat
authors.forename: Maud
authors.initials: M
authors.lastname: Lemoine
authors.forename: Hayette
authors.initials: H
authors.lastname: Rougier
authors.forename: Brigitte
authors.initials: B
authors.lastname: Varsat
authors.forename: Nicolas
authors.initials: N
authors.lastname: Boo
authors.forename: Cécile
authors.initials: C
authors.lastname: Charlois-Ou
authors.forename: Anne
authors.initials: A
authors.lastname: Collignon
authors.forename: Olivier
authors.initials: O
authors.lastname: Cha
authors.forename: Pauline
authors.initials: P
authors.lastname: Campa
authors.forename: Philippe
authors.initials: P
authors.lastname: Dhotte
authors.forename: Pierre-Marie
authors.initials: PM
authors.lastname: Girard
authors.forename: Karine
authors.initials: K
authors.lastname: Lacombe
mesh_terms: D000328:Adult; D005260:Female; D006509:Hepatitis B / Q000175:diagnosis* / Q000276:immunology / Q000517:prevention & control / Q000628:therapy; D006510:Hepatitis B Antibodies / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D010297:Paris; D012017:Referral and Consultation; D012737:Sex Factors; D013997:Time Factors; D055815:Young Adult
chemical_list: D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines