Effectiveness of hepatitis B rapid tests toward linkage-to-care: results of a randomized, multicenter study

Julie Bottero (1, 2) , Anders Boyd (2) , Joël Gozlan (1, 3) , Fabrice Carrat (2, 1) , Maud Lemoine (1) , Hayette Rougier (1) , Brigitte Varsat (4) , Nicolas Boo (5) , Cécile Charlois-Ou (6) , Anne Collignon (7) , Olivier Cha (1) , Pauline Campa (1) , Philippe Dhotte (8) , Pierre-Marie Girard (2, 1) , Karine Lacombe (2, 1)

1 CHU Saint-Antoine [AP-HP]
2 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
3 CIMI - Centre d'Immunologie et de Maladies Infectieuses
4 DEPSA - Département des Examens Périodiques de Santé de l’Adulte
5 DASES - Direction de l'Action Sociale de l'Enfance et de la Santé
6 CDAG - Centre de dépistage anonyme et gratuit de Belleville
7 Laboratoire St Marcel
8 CDAG - Centre de dépistage anonyme et gratuit du Figuier

Objectives: 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. Conclusion: 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

Domaines: Hépatologie et Gastroentérologie

Julie Bottero, Anders Boyd, Joël Gozlan, Fabrice Carrat, Maud Lemoine, et al.. Effectiveness of hepatitis B rapid tests toward linkage-to-care: results of a randomized, multicenter study. European Journal of Gastroenterology & Hepatology, 2016, ⟨10.1097/MEG.0000000000000620⟩. ⟨hal-01297984⟩