Validation of Rapid Point-of-Care Testing for Viral Hepatitis Management in Resource-Limited Settings

JAMES LEATHERS, ; MARIA BELEN PISANO; VIVIANA RÉ; GERTINE VAN OORD; AMIR SULTAN; ANDRE BOONSTRA; JOSE D. DEBES

San Francisco

Encuentro; AASLD The Liver Meeting; 2018

American Association for the Study of Liver Diseases

Background: Hepatitis B virus (HBV) and hepatitis C virus (HCV) infect a large proportion of patients in resource-limited regions. However, many communities are not aware of local prevalence rates of infection, and providers cannot screen for infection due to lack of access to traditional hepatitis serology testing. In this study, we aimed to validate rapid point of care (POC) testing for HBV and HCV infection in three different regions of the world.Methods: We performed rapid POC tests for HBV- surface antigen (HBsAg), envelope antigen (HBeAg), envelope antibody (anti-HBeAb), as well as for anti-HCV antibody in hospitals in the Netherlands, Argentina and Ethiopia. The performance of rapid POC tests was assessed using ROC curve analysis, using the local diagnostic standard as the reference test. Statistical analysis was performed using STATA v15.1 (Statacorp, College Station, TX.). Rapid POC tests were one-step produced by Pre-Check Bio, Korea. Patients co-infected with human immunodeficiency virus were not included in this study. Results: A total of 131 patients (median age 47 years, 65% male) were tested with anti-HCV POC tests (86 known positive, 45 known negative), showing 100% sensitivity and 100% specificity. HCV genotypes 1-4 were tested. A total of 69 patients (median age 38 years, 74% male) were tested for HBsAg in serum (47 known positive, 22 known negative), showing 100% sensitivity and specificity. A total of 56 patients (median age 36 years, 61% male) were tested for anti-HBeAb (12 known positive, 44 known negative), showing a sensitivity of 91% and specificity of 100%. A total of 17 Patients (median age 39 years, 82% male) were tested for HBeAg (11 known positive, 6 known negative) showing a sensitivity of 73% and specificity of 67%. HBV POC tests were performed in HBV genotypes A, B, C, D, E and F.Conclusion: Our preliminary study, performed in 3 different continents and multiple viral genotypes shows that POC for HCV, HBsAg and HBeAb can be used to diagnose HCV infection as well as to diagnose and evaluate HBV infection, as providers can make informed decisions for referral with HBsAg, HBeAb and liver enzymes.