Separation Design Group

Background. Previously, we developed a technique using a panel of monoclonal antibodies (MAB) anti-HBs for determination of the main variants of hepatitis B virus (HBV) genotypes and surface antigen (HBsAg) subtypes circulating on the territory of Russian Federation: ayw2/D, ayw3/D, adw2/A, adrq+/C. The Purpose was to determine HBV genotypes and HBsAg subtypes in HBsAg-positive blood serum samples from patients with chronic HBV infection from three regions of the Russian Federation using the developed reagents. We also wanted to compare the obtained data with the results of molecular biological methods for determining HBV genotypes and HBsAg subtypes and combine them with the results of previous trials. Material and methods. The comparative study included 127 HBsAg-positive blood serum samples from patients with chronic HBV infection from Barnaul, Krasnodar, Blagoveshchensk, collected in 2017-2019. We identified the HBV genotypes and HBsAg subtypes with developed reagents using enzyme-linked immunosorbent assay (ELISA) and by molecular biological methods (analysis of the DNA sequences of hepatitis B virus isolates). Results. Among 127 HBsAg positive samples, in which HBV genotypes/HBsAg subtypes were identified using the reagents we developed, the results were obtained as follows: 65 (51.6%) D/ayw2, 47 (36.5%) D/ayw3, 14 (11.1%) A/adw2, 1 (0.8%) C/adrq+. For 98 samples studied by two methods, the results of determination of HBV genotypes coincided in 100% (98/98) cases, HBsAg subtypes — in 92% (90/98) cases. Conclusion. Using the developed reagents, HBV genotypes and HBsAg subtypes were determined in HBsAg-positive blood serum samples of patients with chronic HBV infection in three regions of the Russian Federation. The obtained new results of comparative tests of the developed reagents for the determination of HBV genotypes and HBsAg subtypes in HBsAg-positive blood serum samples were combined with the data previously published by us.