Abstract
Background Hepatitis B virus (HBV) infection is a leading cause of liver disease worldwide. Hepatitis B surface antigen (HBsAg) rapid diagnostic tests (RDTs) could be an ideal tool for a large-scale HBV screening in settings with high endemicity but limited infrastructure. The aim of this study was to evaluate the diagnosis performance of such RDTs for screening HBV infection in Ivory Coast. Methods From September 2018 to January 2019, a cross-sectional phase I evaluation study of RDTs was conducted in three laboratories of Abidjan (CeDReS, CNTS and IPCI), on a panel of 405 whole blood samples and 699 plasmas. Four HBsAg RDTs (Determine™ HBsAg, SD Bioline HBsAg WB®, Standard Q HBsAg® and Vikia HBsAg®) were evaluated. The diagnostic performance (sensitivity and specificity) was calculated in comparison to the reference sequential algorithms of two EIA tests (Dia.Pro HBsAg® one version ULTRA and Monolisa™ HBsAg ULTRA). Results The Determine™ HBsAg and Vikia HBsAg® tests performed well, with 100% of sensitivity, specificity both on plasma and on whole blood. For SD Bioline HBsAg WB® and Standard Q HBsAg®, the specificities were 99.8% and the sensitivities 99.3% and 97.1% respectively. Finally, there were a total of 19 false negative results: 3 with SD Bioline HBsAg WB® and 16 with Standard Q HBsAg®. Conclusion Determine HBsAg® from Alere and Vikia HBsAg® from Biomérieux are the most suitable RDTs for screening for HBV in Ivory Coast. A phase II evaluation must be initiated.
Highlights
Hepatitis B virus (HBV) is a serious public health problem worldwide and a major cause of chronic hepatitis, cirrhosis, and hepatocellular carcinoma (HCC)
From September 2018 to January 2019, a cross-sectional phase I evaluation study of rapid diagnostic tests (RDTs) was conducted at the Institut Pasteur of Ivory Coast (IPCI), the Center for Diagnosis and Research on AIDS and other infectious diseases (CeDRes) and the National Blood Transfusion Center (NBTC)
According to World Health Organization (WHO) RDTs evaluation guide [11], six hundred ninety-nine (699) serum and plasma samples came from the biobank of IPCI and CeDRes, while four hundred and five (405) whole blood samples were collected from blood donors at the National Blood Transfusion Center
Summary
Hepatitis B virus (HBV) is a serious public health problem worldwide and a major cause of chronic hepatitis, cirrhosis, and hepatocellular carcinoma (HCC). HBsAg is typically detected using sensitive immunoassays with an Journal of Immunology Research immunoassay analyzer in a hospital laboratory setting Such enzyme immunoassays (EIAs) can effectively detect the viral antigens, they have high costs, require dedicated facilities, sophisticated equipment, trained technicians, and a continuous supply of electricity, and have long turnaround times [7]. These drawbacks of laboratory-based immunoassays limit their usefulness in resource-limited settings [8]. Hepatitis B surface antigen (HBsAg) rapid diagnostic tests (RDTs) could be an ideal tool for a large-scale HBV screening in settings with high endemicity but limited infrastructure. The aim of this study was to evaluate the diagnosis performance of such RDTs for screening HBV infection in Ivory Coast.
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