Method and device for estimating amount of tau protein accumulation in subject's brain

A device which estimates an amount of a tau protein accumulated in a brain of a subject,

• the device comprising a processing section, wherein
• regarding a measurement sample which has been prepared by forming, on a capture bead, an immune complex of a phosphorylated tau protein in a biological sample collected from a subject, a detection antibody, and a capture antibody in the presence of a non-capture bead and which contains the non-capture bead and the capture bead to which the immune complex binds, the processing section obtains a signal derived from the immune complex,
• the processing section estimates, based on intensity of the signal, an amount of a tau protein accumulated in a brain of the subject which amount is quantified by tau PET,
• the non-capture bead does not bind to the immune complex,
• one of the detection antibody and the capture antibody is an antibody which recognizes an amino acid sequence from position 151 to position 244 in an amino acid sequence represented by SEQ ID NO. 1,
• the other of the detection antibody and the capture antibody is an antibody which recognizes a phosphorylated epitope including a phosphorylated amino acid residue in the amino acid sequence represented by SEQ ID NO. 1, and
• the intensity of the signal does not correlate with an amount of amyloid accumulated in the brain of the subject which amount is quantified by amyloid PET.

A device which obtains information for evaluating a degree of progression of a tauopathy in a subject, based on intensity of a signal derived from a phosphorylated tau protein in a biological sample collected from the subject,

• the device comprising a processing section, wherein
• regarding a measurement sample which has been prepared by forming, on a capture bead, an immune complex of a phosphorylated tau protein in a biological sample collected from a subject, a detection antibody, and a capture antibody in the presence of a non-capture bead and which contains the non-capture bead and the capture bead to which the immune complex binds, the processing section obtains a signal derived from the immune complex,
• the processing section estimates, based on intensity of the signal, an amount of a tau protein accumulated in a brain of the subject which amount is quantified by tau PET,
• the processing section obtains information for evaluating a degree of progression of a tauopathy in the subject, based on the amount of the tau protein accumulated in the brain of the subject which amount has been estimated,
• the non-capture bead does not bind to the immune complex,
• one of the detection antibody and the capture antibody is an antibody which recognizes an amino acid sequence from position 151 to position 244 in an amino acid sequence represented by SEQ ID NO. 1,
• the other of the detection antibody and the capture antibody is an antibody which recognizes a phosphorylated epitope including a phosphorylated amino acid residue in the amino acid sequence represented by SEQ ID NO. 1, and
• the intensity of the signal does not correlate with an amount of amyloid accumulated in the brain of the subject which amount is quantified by amyloid PET.