Immunochromatographic assay apparatus

Patent metadata

Field	Value
Publication number	US-2023393132-A1
Application number	US-202318452029-A
Country	US
Kind code	A1
Filing date	Aug 18, 2023
Priority date	Mar 24, 2021
Publication date	Dec 7, 2023
Grant date	—

Abstract

An assay apparatus includes a loading part in which a cartridge including a carrier having a spotting region and an assay region is loaded, an imaging unit that images the assay region, and a processor configured to perform a main determination, based on an assay region image, wherein the processor is configured to perform an abnormality determination for determining presence or absence of an abnormality in the assay region image, using, as a determination index, at least one of a difference between a relatively large pixel value and a relatively small pixel value in at least one column in the assay region image, a standard deviation based on the pixel values in each of the columns, or a variation coefficient based on the pixel values in each of the columns, and determine the processing content related to the main determination based on the presence or absence of the abnormality.

First claim

What is claimed is:

1 . An immunochromatographic assay apparatus comprising:
a loading part in which a cartridge including 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, is attachably and detachably loaded; an imaging unit that images the assay region; and a processor configured to perform a main determination, which is a determination of whether the sample is positive or negative, based on an assay region image of the assay region imaged by the imaging unit, wherein in a case where a development direction of the sample in the carrier is a row direction and a direction intersecting the row direction is a column direction, the assay region is a line-shaped region extending along the column direction, the assay region image is an image in which a plurality of pixels are two-dimensionally arranged in a matrix form, the processor is configured to perform an abnormality determination for determining presence or absence of an abnormality in the assay region image, using, as a determination index, at least one of a difference between a relatively large pixel value and a relatively small pixel value in at least one column in the assay region image, a standard deviation based on pixel values in each of the columns, or a variation coefficient based on pixel values in each of the columns, or at least one of a difference between a relatively large representative value and a relatively small representative value among representative values of all rows, which is derived based on a plurality of pixels existing in different columns in the same row in the assay region image, a standard deviation based on the representative values of all the rows, or a variation coefficient based on the representative values of all the rows, and determine a processing content related to the main determination based on the presence or absence of the abnormality.

2 . The immunochromatographic assay apparatus according to claim 1 ,
wherein the processing content includes any one of whether or not to perform the main determination or a method of presenting a determination result of the main determination.

3 . The immunochromatographic assay apparatus according to claim 2 ,
wherein the processor is configured to perform the main determination to present the main determination result in a case where the abnormality is absent, or not to perform the main determination in a case where the abnormality is present.

4 . The immunochromatographic assay apparatus according to claim 3 ,
wherein the processor is configured to present that the main determination is not performed in a case where the main determination is not performed.

5 . The immunochromatographic assay apparatus according to claim 3 ,
wherein the processor is configured to present that the assay region may be stained in a case where the abnormality is present.

6 . The immunochromatographic assay apparatus according to claim 4 ,
wherein the processor is configured to present that the assay region may be stained in a case where the abnormality is present.

7 . The immunochromatographic assay apparatus according to claim 2 ,
wherein the processor is configured to present a determination result of the main determination in a case where the abnormality is absent, and present the determination result of the main determination with reservation indicating that the assay region image has an abnormality or not present the determination result of the main determination in a case where the abnormality is present and in a case where the determination result of the main determination is positive.

8 . The immunochromatographic assay apparatus according to claim 7 ,
wherein the processor is configured to perform the main determination, and perform the abnormality determination in a case where a determination result is positive.

9 . The immunochromatographic assay apparatus according to claim 2 ,
wherein the processor is configured to present a determination result of the main determination in a case where the abnormality is absent, or present the determination result of the main determination with reservation indicating that the assay region image has an abnormality or not present the determination result of the main determination in a case where the abnormality is present.

10 . The immunochromatographic assay apparatus according to claim 1 ,
wherein the imaging unit is an image sensor that images an observation region including the assay region to output an observation image including the observation region, the observation image is an image in which a plurality of pixels are two-dimensionally arranged in a matrix form, and the processor is configured to derive a profile in the row direction based on the representative values of the respective columns in the observation image, and extract the assay region image corresponding to the assay region from the observation image based on the derived profile.

Assignees

• Fujifilm Corp

Inventors

• Tanaka Yasutake

Classifications

• G01N33/54389 Primary

  with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones · CPC title

• G01N21/17

  Systems in which incident light is modified in accordance with the properties of the material investigated (where the material investigated is optically excited causing a change in wavelength of the incident light G01N21/63) · CPC title

• G01N2021/1765

  Method using an image detector and processing of image signal · CPC title

• G01N21/8483 Primary

  Investigating reagent band (test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04) · 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