IP Library Granted Patent US 12669504
Granted Patent B2
US 12669504 · App. 18/265,816 · Granted Jun 30, 2026

Method for detecting particulate substance by immunochromatography, and kit for the same

Inventors: Yuta Miyazawa (Utsunomiya, JP); Hirotaka Fujimoto (Kyoto, JP); Makoto Watanabe (Kyoto, JP); Taka-Aki Sato (Kyoto, JP)
Assignees: DAI NIPPON TORYO CO., LTD.; SHIMADZU CORPORATION
G01N33/57515G01N33/54387G01N33/57585G01N2470/04
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12669504
App. No.
18/265,816
Granted
Jun 30, 2026
Kind
B2
Abstract

An object of the present invention is to provide a method for detecting particulate substances with a high degree of sensitivity, while suppressing the generation of non-specific signals. According to the present invention, the generation of non-specific signals in the background can be suppressed by blocking a membrane of a test strip which is used for immunochromatography with a blocking composition including a polymer-based blocking agent having, in its side chain, a substituent represented by the following formula: (wherein R 1 , R 2 , and R 3 are each independently a hydrogen atom, a C 1-6 alkyl group, or a C 1-6 hydroxyalkyl group; and n is an integer of 1 to 4), and having a weight average molecular weight (Mw) of 1×10 3 to 1×10 7 .

Claims (25)

1 . A method for detecting a particulate substance contained in various body fluids, including breast milk, saliva, and tears, as well as blood and urine; preservative solutions for tissue sections; or cell culture supernatants by immunochromatography, the particulate substance comprising, on its surface, a plurality of substances to be bound including a first substance to be bound and a second substance to be bound that may be the same or different from each other, the method comprising steps of:

providing a test strip comprising a membrane on which a first specific binding substance for the first substance to be bound is immobilized, wherein the membrane is blocked with a blocking composition comprising a polymer-based blocking agent having, in its side chain, a substituent represented by the following formula:

(wherein R 1 , R 2 , and R 2 are each independently a hydrogen atom, a C 1-6 alkyl group, or a C 1-6 hydroxyalkyl group; and n is an integer of 1 to 4), and having a weight average molecular weight (Mw) of 1×10 3 to 1×10 7 ;

providing a second specific binding substance for the second substance to be bound, the second specific binding substance binding to a labeling substance;

contacting a sample containing the particulate substance with the first specific binding substance to capture the particulate substance on the membrane;

contacting the particulate substance with the second specific binding substance to label the particulate substance;

detecting the labeled particulate substance captured on the membrane.

2 . The method according to claim 1 , wherein the particulate substance comprises extracellular vesicles.

3 . The method according to claim 2 , wherein the extracellular vesicles are exosomes.

4 . The method according to claim 1 , wherein the detecting step is performed by measuring chemiluminescence or fluorescence.

5 . The method according to claim 1 , wherein the labeling step is performed in the presence of the polymer-based blocking agent.

6 . The method according to claim 1 , wherein the polymer-based blocking agent is LIPIDURE®.

7 . The method according to claim 1 , wherein the blocking composition further comprises an additional blocking agent.

8 . A method for producing a kit for detecting a particulate substance contained in various body fluids, including breast milk, saliva, and tears, as well as blood and urine; preservative solutions for tissue sections; or cell culture supernatants by immunochromatography, the particulate substance comprising, on its surface, a plurality of substances to be bound including a first substance to be bound and a second substance to be bound that may be the same or different from each other, the method comprising steps of:

providing a test strip comprising a membrane on which a first specific binding substance for the first substance to be bound is immobilized;

providing, in order to block the membrane, a blocking composition comprising a polymer-based blocking agent having, in its side chain, a substituent represented by the following formula:

(wherein R 1 , R 2 , and R 2 are each independently a hydrogen atom, a C 1-6 alkyl group, or a C 1-6 hydroxyalkyl group; and n is an integer of 1 to 4), and having a weight average molecular weight (Mw) of 1×10 3 to 1×10 7 ;

blocking the membrane with the blocking composition.

9 . The production method according to claim 8 , further comprising steps of:

providing a second specific binding substance for the second substance to be bound, the second specific binding substance binding to a labeling substance; and

blocking the second specific binding substance with the blocking composition.

10 . A kit for detecting a particulate substance contained in various body fluids, including breast milk, saliva, and tears, as well as blood and urine; preservative solutions for tissue sections; or cell culture supernatants by immunochromatography, the particulate substance comprising, on its surface, a plurality of substances to be bound including a first substance to be bound and a second substance to be bound that may be the same or different from each other, the kit comprising:

a test strip comprising a membrane on which a first specific binding substance for the first substance to be bound is immobilized, wherein the membrane is blocked with a blocking composition comprising a polymer-based blocking agent having, in its side chain, a substituent represented by the following formula:

(wherein R 1 , R 2 , and R 2 are each independently a hydrogen atom, a C 1-6 alkyl group, or a C 1-6 hydroxyalkyl group; and n is an integer of 1 to 4), and having a weight average molecular weight (Mw) of 1×10 3 to 1×10 7 ;

a second specific binding substance for the second substance to be bound, the second specific binding substance binding to a labeling substance.