Recombinant HBV Surface Antigen (subtype adw, mutation M-133-H)

In this work, the reduced metal-organic frameworks (MOFs) that can function as a three-dimensional catalytic nanoreactor for copper-catalyzed azide-alkyne cycloaddition (CuAAC) click reaction have been fabricated for development of the immunoassay. In our design, MOFs with well-defined porosity are accessible to the substrates of CuAAC, while the substrates can diffuse in the pore channel. Moreover, the high-ordered structural alignments of MOFs are beneficial for integration of copper ions into the three-dimensional lattice. Therefore, upon exposure to reduction, the copper nodes in MOFs are transformed from Cu-II to Cu-I in situ to achieve spatiotemporal control, eliminating the primarily dissolution procedure. Furthermore, the reduced MOFs can serve as a powerful catalyst to facilitate the CuAAC click reaction, which can greatly reduce time and improve the reaction efficiency. In addition, the proposed immunoassay shows high analytical performance for hepatitis B virus surface antigen (HBsAg) quantification in the linear range of 0.03-2.0 ng mL(-1) with a detection limit down to 11.2 pg mL(-1). The new immunoassay has also been challenged in detection of clinical serum sample, and a good consistency can be found with the time-resolved fluorescence immunoassay (TRFIA) in clinics, signifying its promising potential in clinical diagnosis.

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 (TM) HBsAg, SD Bioline HBsAg WB (R), Standard Q HBsAg (R) and Vikia HBsAg (R)) were evaluated. The diagnostic performance (sensitivity and specificity) was calculated in comparison to the reference sequential algorithms of two EIA tests (Dia.Pro HBsAg (R) one version ULTRA and Monolisa (TM) HBsAg ULTRA).Results. The Determine (TM) HBsAg and Vikia HBsAg (R) tests performed well, with 100% of sensitivity, specificity both on plasma and on whole blood. For SD Bioline HBsAg WB (R) and Standard Q HBsAg (R), 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 (R) and 16 with Standard Q HBsAg (R).Conclusion. Determine HBsAg (R) from Alere and Vikia HBsAg (R) from Biomerieux are the most suitable RDTs for screening for HBV in Ivory Coast. A phase II evaluation must be initiated.