The use of ORF2 and ORF3 proteins for creating an enzyme-linked immunosorbent assay for viral hepatitis E

Due to the lack of national analogies a prototype of enzyme-linked immunosorbent assay (ELISA) test system was developed for the qualitative determination of antibodies class G to hepatitis E virus (HEV) based on the using of antigenic polypeptides ORF2 and ORF3 of the 3rd genotype (FSBSI «I.I. Mechnikov Research Institute of Vaccines and Serums», Russia). The results of experimental ELISA conducted in parallel with the reference test system «DS-ELISA-ANTI-HEV-G» (NPO Diagnostic Systems, Russia) are presented. The working concentrations of ORF2 and ORF3 antigens were 2.5 µg/mL and 0.25 µg/mL, respectively. They were tested with 200 donors and patients’ serum samples. The article reflects the determination of sensitivity, specificity and reproducibility results. The developed test system demonstrated high efficiency in the detection of specific anti-HEV-IgG.