Test instrument for measuring analyte in sample by an aggregation assay using a metal colloid and using a reagent attached in a dry state in a reaction chamber, and method for measuring analyte using same

Patent metadata

Field	Value
Publication number	US-10670586-B2
Application number	US-201113639582-A
Country	US
Kind code	B2
Filing date	Apr 4, 2011
Priority date	Apr 14, 2010
Publication date	Jun 2, 2020
Grant date	Jun 2, 2020

Abstract

Disclosed is a test instrument for measuring an analyte in a liquid sample by a noble metal colloid aggregation measurement method. The test instrument involves a reaction chamber in which at least the liquid sample is to be reacted with a reagent, wherein the reagent is adhered on at least a part of a surface constituting the reaction chamber in a dried state, and the reagent enables the measurement of the analyte by a noble metal colloid aggregation measurement method. The test instrument additionally involves a supply section for supplying the liquid sample and a flow path for delivering the liquid sample that has been supplied to the supply section to the reaction chamber, wherein the liquid sample that has been supplied to the supply section is delivered to the reaction chamber through the flow path to cause the liquid sample to be brought into contact with the reagent that has been adhered in a dried state, thereby producing a difference in pressure between the supply section and the reaction chamber for the purpose of dispersing the reagent in the liquid sample. When the test instrument is used, the measurement based on an absorbance at a visible region can be achieved, the analyte can be measured accurately within a short time, and the measurement suitable for a POCT field can be achieved.

First claim

The invention claimed is:

1. A test instrument for spectrophotometrically and quantitatively assaying an analyte in a liquid sample by aggregation assay using dry particles of noble metal, the test instrument comprising:
a reaction chamber;
reagents attached in a dry state to at least a portion of a surface constituting the reaction chamber, wherein the reagents include
(i) dry particles of noble metal sensitized with a partner specifically binding to the analyte; or
(ii) a partner specifically binding to the analyte and dry particles of noble metal sensitized with the same substance as the analyte,
wherein said noble metal particles are capable of forming a noble metal colloid upon contact with the liquid sample, for assaying the analyte by the aggregation assay using a noble metal colloid and the particle size of the noble metal colloid is 20 to 150 nm;
a sample supply unit for supplying the liquid sample;
a channel for transporting the liquid sample supplied to the sample supply unit into the reaction chamber; and,
a stopper which covers the sample supply unit after the liquid sample is supplied to the sample supply unit,
wherein, by pressurizing the stopper, the test instrument is capable of generating a pressure difference between the sample supply unit and the reaction chamber such that the liquid sample supplied to the sample supply unit is transported into the reaction chamber via the channel and contacted with the reagent attached in a dry state to disperse the reagent in the liquid sample.

2. The test instrument according to claim 1 , wherein the surface constituting the reaction chamber comprises:
a first planar surface,
a second planar surface facing the first planar surface, and
a third surface being in contact with both the first planar surface and the second planar surface and defining a space between the first planar surface and the second planar surface,
wherein
the reagents include said reagent (i).

3. The test instrument according to claim 1 , wherein the surface constituting the reaction chamber comprises:
a first planar surface,
a second planar surface facing the first planar surface, and
a third surface being in contact with both the first planar surface and the second planar surface and defining a space between the first planar surface and the second planar surface,
wherein the reagents include said reagent (ii);
said partner specifically binding to the analyte is attached in a dry state to the first planar surface; and said dry particles of noble metal are attached to the second planar surface.

4. The test instrument according to claim 1 , wherein the noble metal particles are gold particles or palladium particles.

5. The test instrument according to claim 1 , wherein the channel and the reaction chamber are connected to an outside of the test instrument via an air-permeable and liquid-impermeable porous membrane.

6. The test instrument according to claim 1 , wherein the liquid sample is a biological sample, and the analyte is a biogenic component.

7. The test instrument according to claim 1 , further comprising, between the sample supply unit and the channel, a membrane for separating a solid from the liquid sample.

8. The test instrument according to claim 1 , wherein the average particle size of the noble metal colloid prior to aggregation is 50 nm.

9. The test instrument according to claim 1 , wherein the dry particles are a noble metal colloid.

10. The test instrument according to claim 9 , wherein the noble metal is selected from the group consisting of gold, silver, palladium and platinum.

11. The test instrument according to claim 10 , wherein the noble metal is gold.

12. The test instrument according to claim 10 , wherein the noble metal is platinum.

13. The test instrument according to claim 9 , wherein the dry particles are an anti-human CRP antibody-sensitized gold colloid.

14. The test instrument according to claim 9 , wherein the dry particles comprise an anti-human CRP antibody-sensitized gold colloid.

15. The test instrument according to claim 14 , wherein dry particles further comprise sorbitol and a surfactant.

16. An apparatus for assaying an analyte in a liquid sample, comprising a test instrument according to claim 1 in combination with a visible spectrophotometer for irradiating the reaction chamber with light and reading transmitted light or reflected light.

Assignees

• Kojima Ryo
• Noda Kenta
• Sato Yoshiro
• Sato Natsuki
• Ashizawa Kaduho
• Nitto Boseki Co Ltd

Inventors

• Kojima Ryo
• Noda Kenta
• Sato Yoshiro
• Sato Natsuki
• Ashizawa Kaduho

Classifications

• B01L3/5027

  by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip · CPC title

• B01L3/50273

  characterised by the means or forces applied to move the fluids · CPC title

• G01N33/54313 Primary

  the carrier being characterised by its particulate form · CPC title

• B01L2400/0475

  specific mechanical means and fluid pressure · CPC title

• B01L2400/0487

  fluid pressure, pneumatics · CPC title