The present invention discloses a method and a kit for detecting
botulinum toxin activity or synaptosome-associated proteins. The method comprises the step of contacting a sample to be tested with an
antibody or an
antigen-binding fragment thereof, wherein the
antibody or the
antigen-binding fragment thereof targets the synaptosome-associated
protein or its cleavage fragment. The present invention obtains a humanized single-chain
antibody against synaptosome-associated proteins from an antibody
library, thereby ensuring that the antibodies are fully humanized, constructs a eukaryotic
expression vector with the aid of
genetic engineering technology, and expresses the antibodies in eukaryotic cells. In addition, the present invention converts the obtained fully humanized single-chain antibody into a specific fully humanized
complete antibody, which is then separated and purified, and its biological properties such as specificity and affinity are evaluated, thereby establishing a method for detecting
botulinum toxin activity and a method for detecting synaptosome-associated proteins. In addition, the affinity of the anti-synaptosome-associated
protein antibody of the present invention is higher than that of the commercially available rabbit synaptosome-associated
protein polyclonal antibody.