Immunochromatographic assay apparatus

Patent metadata

Field	Value
Publication number	US-2023386173-A1
Application number	US-202318450180-A
Country	US
Kind code	A1
Filing date	Aug 15, 2023
Priority date	Mar 24, 2021
Publication date	Nov 30, 2023
Grant date	—

Abstract

An immunochromatographic assay apparatus includes a loading part in which a cartridge that includes a carrier having a spotting region and an assay region, and in which a reagent is supplied to the carrier, is attachably and detachably loaded, a first detection unit that detects a color development state in the assay region, a second detection unit that detects a generation state of bubbles generated in the assay region due to the supply of the reagent, and a processor configured to discriminate presence or absence of a change in the color development state based on the color development state detected by the first detection unit, and discriminate the presence or absence of the change in the color development state in a case where the bubbles are discriminated to be absent based on the generation state of the bubbles detected by the second detection unit.

First claim

What is claimed is:

1 . An immunochromatographic assay apparatus comprising:
a loading part in which a cartridge that includes a carrier having a spotting region on which a sample is spotted and an assay region in which a color development state changes depending on whether the sample is positive or negative, and in which a reagent is supplied to the carrier, is attachably and detachably loaded; a first detection unit that detects a color development state in the assay region; a second detection unit that detects a generation state of bubbles generated in the assay region due to the supply of the reagent; and a processor configured to discriminate presence or absence of a change in the color development state based on the color development state detected by the first detection unit, and discriminate the presence or absence of the change in the color development state in a case where the bubbles are discriminated to be absent based on the generation state of the bubbles detected by the second detection unit.

2 . The immunochromatographic assay apparatus according to claim 1 ,
wherein the second detection unit is an image sensor that images an observation region including the assay region and a peripheral region of the assay region to output an observation image including the observation region.

3 . The immunochromatographic assay apparatus according to claim 2 ,
wherein the processor is configured to obtain a standard deviation of pixel values of an image of a region of interest within the observation region, and discriminate the bubbles to be absent in a case where the standard deviation is not more than a preset threshold value.

4 . The immunochromatographic assay apparatus according to claim 2 ,
wherein the processor is configured to derive a difference or a ratio between a pixel value, between a reference image in a state where bubbles are absent and an image of a region of interest within the observation region, and discriminate the bubbles to be absent in a case where the difference or the ratio is not more than a preset threshold value.

5 . The immunochromatographic assay apparatus according to claim 1 ,
wherein in a case where the bubbles are discriminated to be present, the processor is configured to discriminate presence or absence of the bubbles again after a lapse of a preset first setting time.

6 . The immunochromatographic assay apparatus according to claim 1 ,
wherein in a case where it is discriminated that the bubbles are present even after a lapse of a preset second setting time from a preset time point after the cartridge is loaded, the processor is configured to notify an error.

7 . The immunochromatographic assay apparatus according to claim 2 ,
wherein the processor is configured to acquire two or more of observation images having a time difference from the second detection unit, derive a difference or a ratio between pixel values, between images of a region of interest within the observation region in the two or more of observation images, and discriminate the bubbles to be absent in a case where the difference or the ratio is not more than a preset threshold value.

8 . The immunochromatographic assay apparatus according to claim 1 ,
wherein the first detection unit is an imaging unit that images an observation region including the assay region and a peripheral region thereof, and the first detection unit and the second detection unit are used in common.

9 . The immunochromatographic assay apparatus according to claim 1 ,
wherein the cartridge includes a cover member that covers the carrier, and in the cover member, has a gap of 0.01 to 1 mm in which a reagent is supplied between a surface of the carrier in the assay region and the cover member, and the reagent is developed in the assay region using the gap as a flow channel.

10 . The immunochromatographic assay apparatus according to claim 1 ,
wherein the cartridge includes a first reagent holding part that holds a first reagent to be supplied to the carrier and a second reagent holding part that holds a second reagent to be supplied to the carrier after the first reagent is supplied to the carrier, the reagent that is a cause for generation of the bubbles is the second reagent, and the processor is configured to discriminate presence or absence of the bubbles after the second reagent is supplied to the carrier.

Assignees

• Fujifilm Corp

Inventors

• Tanaka Yasutake
• Ishii Hiroyasu

Classifications

• G06V10/72 Primary

  Data preparation, e.g. statistical preprocessing of image or video features · CPC title

• G01N21/77

  by observing the effect on a chemical indicator · CPC title

• G01N33/54387 Primary

  Immunochromatographic test strips · CPC title

• G01N2021/7759

  Dipstick; Test strip · CPC title

• G01N35/00

  Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor · CPC title