Diagnosing a disease associated with synaptic degeneration using an ELISA for determining a beta-synuclein concentration in CSF
In an ex vivo method of diagnosing a disease associated with synaptic degeneration, a concentration of beta-synuclein in a cerebrospinal fluid (CSF) sample taken from a patient is determined by an enzyme-linked immunosorbent assay (ELISA).
1 . An assay kit for determining a concentration of beta-synuclein in a cerebrospinal fluid (CSF) sample taken from a patient, for use in an ex vivo method of diagnosing a disease associated with synaptic degeneration, the method comprising
obtaining a cerebrospinal fluid (CSF) sample taken from a patient, and
determining a concentration of beta-synuclein in the cerebrospinal fluid (CSF), the assay kit comprising
a sandwich enzyme-linked immunosorbent assay (ELISA) for determining the concentration of beta-synuclein in the cerebrospinal fluid (CSF) sample,
wherein the sandwich ELISA includes capture and detection antibodies against beta-synuclein, and
wherein the capture and detection antibodies include a monoclonal capture antibody against beta- and alpha-synuclein and a detection antibody specific for beta-synuclein.
2 . The assay kit of claim 1 , wherein the detection antibody is a biotinylated antibody.
3 . The assay kit of claim 1 , further comprising a plurality of beta-synuclein calibrators prepared from recombinant beta-synuclein and blocking buffer, each of the calibrators of the plurality of the beta-synuclein calibrators comprising recombinant beta-synuclein and blocking buffer, and the beta-synuclein concentrations of the plurality of the beta-synuclein calibrators ranging from 10 pg/ml to at least 1,000 pg/ml.