IP Library Granted Patent US 12687546
Granted Patent B2
US 12687546 · App. 17/390,010 · Granted Jul 21, 2026

Reagent kit, measurement kit, and measurement method

Inventors: Kazuhiro Nakamura (Ashigarakami-gun, JP); Ryo Ouchi (Ashigarakami-gun, JP); Takeru Shigemura (Ashigarakami-gun, JP)
Assignee: FUJIFILM Corporation
G01N33/6839G01N21/6428G01N33/543B82Y5/00B82Y35/00G01N2021/6439
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Quick Facts
Patent No.
US 12687546
App. No.
17/390,010
Granted
Jul 21, 2026
Kind
B2
Abstract

An object of the present invention is to provide a reagent kit, a measurement kit, and a measurement method for measuring serum amyloid A, which enable simple and rapid measurement of serum amyloid A by promoting dissociation of the serum amyloid A from HDL and carrying out an antigen-antibody reaction. According to the present invention, provided is a reagent kit for measuring serum amyloid A, including first particles having a label and modified with a first binding substance having a property of specifically binding to serum amyloid A, at least one nonionic surfactant having an HLB value of 17 to 20, which is defined by (inorganicity value/organicity value)×10, and a molecular weight of 1000 or less, and a buffer capable of adjusting a pH of a reaction solution to be in a range of 5.5 to 7.0 or a range of 8.5 to 9.0.

Claims (51)

1 . A reagent kit for measuring serum amyloid A, comprising:

first particles having a label and modified with a first binding substance having a property of specifically binding to serum amyloid A;

at least one nonionic surfactant having a hydrophilic-lipophilic balance value of 17 to 20, which is defined by (inorganicity value/organicity value)×10, and a molecular weight of 1000 or less; and

a buffer adjusting a pH of a reaction solution to be in a range of 5.5 to 7.0 or a range of 8.5 to 9.0.

2 . The reagent kit according to claim 1 ,

wherein an average particle diameter of the first particles is in a range of 70 nm to 500 nm.

3 . The reagent kit according to claim 1 , further comprising:

second particles which are modified with a second binding substance having no property of specifically binding to serum amyloid A and do not have a label.

4 . The reagent kit according to claim 3 ,

wherein an average particle diameter of the second particles is in a range of 70 nm to 500 nm.

5 . The reagent kit according to claim 1 ,

wherein the label includes a fluorescent dye.

6 . The reagent kit according to claim 1 ,

wherein the serum amyloid A is serum amyloid A in cat serum or cat plasma.

7 . The reagent kit according to claim 1 ,

wherein the buffer is 2-(N-morpholino) ethanesulfonic acid or N,N-bis(2-hydroxyethyl)glycine.

8 . The reagent kit according to claim 1 ,

wherein the first binding substance is an antibody.

9 . A measurement kit for serum amyloid A, comprising:

the reagent kit according to claim 1 ; and

a substrate on which a first metal film is formed, and a third binding substance having a property of specifically binding to serum amyloid A or of specifically binding to the first binding substance is fixed to the first metal film.

10 . The measurement kit according to claim 9 ,

wherein a second metal film is further formed on the substrate and a fourth binding substance having a property of specifically binding to the first binding substance, but not having a property of binding to serum amyloid A is fixed to the second metal film.

11 . A measurement kit for serum amyloid A, comprising:

the reagent kit according to claim 2 ; and

a substrate on which a first metal film is formed, and a third binding substance having a property of specifically binding to serum amyloid A or of specifically binding to the first binding substance is fixed to the first metal film.

12 . A measurement kit for serum amyloid A, comprising:

the reagent kit according to claim 3 ; and

a substrate on which a first metal film is formed, and a third binding substance having a property of specifically binding to serum amyloid A or of specifically binding to the first binding substance is fixed to the first metal film.

13 . A measurement kit for serum amyloid A, comprising:

the reagent kit according to claim 4 ; and

a substrate on which a first metal film is formed, and a third binding substance having a property of specifically binding to serum amyloid A or of specifically binding to the first binding substance is fixed to the first metal film.

14 . A measurement kit for serum amyloid A, comprising:

the reagent kit according to claim 5 ; and

a substrate on which a first metal film is formed, and a third binding substance having a property of specifically binding to serum amyloid A or of specifically binding to the first binding substance is fixed to the first metal film.

15 . A measurement kit for serum amyloid A, comprising:

the reagent kit according to claim 6 ; and

a substrate on which a first metal film is formed, and a third binding substance having a property of specifically binding to serum amyloid A or of specifically binding to the first binding substance is fixed to the first metal film.

16 . A measurement kit for serum amyloid A, comprising:

the reagent kit according to claim 7 ; and

a substrate on which a first metal film is formed, and a third binding substance having a property of specifically binding to serum amyloid A or of specifically binding to the first binding substance is fixed to the first metal film.

17 . A measurement kit for serum amyloid A, comprising:

the reagent kit according to claim 8 ; and

a substrate on which a first metal film is formed, and a third binding substance having a property of specifically binding to serum amyloid A or of specifically binding to the first binding substance is fixed to the first metal film.

18 . A measurement method for serum amyloid A in a biological sample, the method comprising:

a step of preparing a mixed solution which contains a biological sample containing serum amyloid A, first particles having a label and modified with a first binding substance having a property of specifically binding to serum amyloid A, at least one nonionic surfactant having a hydrophilic-lipophilic balance value of 17 to 20, which is defined by (inorganicity value/organicity value)×10, and a molecular weight of 1000 or less, and a buffer adjusting a pH of a reaction solution to be in a range of 5.5 to 7.0 or a range of 8.5 to 9.0;

a step of adding the mixed solution to an injection port at one end of a substrate on which a first metal film on which a third binding substance having a property of specifically binding to serum amyloid A is fixed is formed;

a step of allowing the mixed solution to flow down onto the substrate; and

a step of acquiring information of the label on the first metal film.

19 . The measurement method for serum amyloid A according to claim 18 ,

wherein in a case where the mixed solution is prepared, the biological sample is diluted with physiological saline at a dilution ratio of 4 times to 100 times.