TEST SYSTEM FOR DETERMINING SPECIFIC ACTIVITY OF INFLUENZA VIRUS AND METHOD FOR ITS OBTAINING Russian patent published in 2023 - IPC G01N33/53 C12Q1/00 

FIELD: biotechnology.

SUBSTANCE: method for obtaining standard influenza virus hemagglutinin. Obtain a diluted viral concentrate, including a purified viral concentrate and a phosphate-buffered solution. Stabilize the diluted viral concentrate by adding a solution of bovine serum albumin. Obtain standard influenza virus hemagglutinin with a concentration of at least 60 μg/ml. A method for obtaining a monospecific serum standard for influenza virus hemagglutinin is also described. The purified viral concentrate is treated with the enzyme bromelain. The resulting viral concentrate is purified by size exclusion chromatography on sorbents with a fractionation range from 10 to 1500 kDa. Repeated immunization of sheep or rabbits is carried out with the antigen obtained by the method given above, in combination with Freund's adjuvant. Native immune serum is obtained by repeated immunization of animals, with an antigen titer of at least 1:8 in Ouchterlony immunodiffusion. Also a test system for determining the specific activity of the influenza virus or for determining the specific activity of the influenza vaccine is presented. The invention makes it possible to obtain standard samples: standard influenza virus hemagglutinin and a monospecific serum standard for influenza virus hemagglutinin for use in the SRID analysis method to determine specific activity, incl. in the test system.

EFFECT: standard samples have a quality comparable to or improved relative to the prior art, have proven effectiveness, and can be obtained from animals of various species.

10 cl, 5 dwg, 5 tbl, 5 ex