FIELD: medicine.
SUBSTANCE: invention refers to immunology and can be used for quantitative determination of antigen content. Disclosed is a method for quantitative determination of an antigen in a vaccine, which is a mixture of recombinant anatoxin aToX and an OprF outer membrane protein adsorbed on aluminium hydroxide particles, consisting in immobilising the free analysed antigen in the wells of a plate for enzyme immunoassay; to dilutions of the vaccine preparation containing aluminium hydroxide particles with the analysed antigen sorbed thereon, monoclonal antibodies conjugated with peroxidase specific to the analysed antigen are added; separation of centrifugation-free antibodies conjugated with peroxidase, from aluminium hydroxide particles with the formed immune complex; at the third stage, the supernatant is placed in a plate with immobilized analysed antigens, the amount of non-bound antibodies is determined by direct solid-phase enzyme immunoassay, thereafter, antigen content adsorbed on aluminium hydroxide particles in the vaccine preparation is determined by a residual amount of antibodies not bound with the vaccine preparation.
EFFECT: invention provides detection of antigens in a vaccine preparation excluding the stage of desorption of antigens on particles of aluminium hydroxide.
5 cl, 3 dwg, 2 tbl, 1 ex
Authors
Dates
2020-03-04—Published
2019-02-21—Filed