FIELD: biotechnology.
SUBSTANCE: invention refers to biotechnology and represents a method for quantitative determination of antibodies that bind to AAV, in vitro, involving: (a) obtaining infectious recombinant AAV particles containing a recombinant AAV vector, wherein the recombinant AAV vector comprises a reporter transgene, wherein the reporter transgene comprises (a) a single-stranded or self-complementary genome, (b) is operably linked to one or more regulatory expression elements, and (c) is flanked by one or more flanking elements; (b) obtaining a biological sample from an individual; (c) obtaining cells that can be infected with said infectious particles of recombinant AAV; (d) bringing into contact or incubation of infectious particles of recombinant AAV (a) with biological sample (b), thereby obtaining the obtained mixture (M); (e) bringing the cells into contact (c) with the obtained mixture (M) under conditions in which the recombinant AAV (a) infectious particles can infect and express the reporter transgene in said cells; (f) measuring reporter transgene expression and (g) comparing said reporter transgene (f) expression with a negative (-) control reporter transgene, (i) an antibody-free transporter that binds to AAV, and (+) control, (ii) containing a predefined number of antibodies that bind to AAV, thereby quantitatively determining antibodies in the biological sample that bind to AAV.
EFFECT: disclosed are the AAV vector and neutralizing anti-AAV analysis.
64 cl, 5 tbl, 5 ex
