# US 10,502,685 B2 · Method for urine sample analysis, reagent for urine sample analysis, and reagent kit for urine sample analysis

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- Number: US 10,502,685 B2
- Document ID: US10502685B2
- Status: Granted
- Kind: B2
- Application number: 15/121,250
- Filed: 2015-02-27
- Published: 2016-12-15
- Granted: 2019-12-10
- Earliest claimed: 2014-02-28
- Assignees: Sysmex Corporation
- Applicants: Sysmex Corporation
- Inventors: Akinori Kawai
- Web page: https://patentgrep.com/patent/US10502685B2

## CPC

- G01N 21/6428: {Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" (in vivo A61B5/00; immunoassay G01N33/53)}
- G01N 15/1434: Optical arrangements
- G01N 21/49: within a body or fluid
- G01N 21/6458: {Fluorescence microscopy (fluorescence microscopes per se G02B21/0076 and G02B21/16)}
- G01N 33/493: urine
- G01N 33/52: Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper {and including single- and multilayer analytical elements (immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72)}
- G01N 33/80: involving blood groups or blood types {or red blood cells (white blood cells G01N33/56972)}
- G01N 15/01: specially adapted for biological cells, e.g. blood cells (investigating sedimentation of particle suspensions in blood G01N15/05)
- G01N 2021/6439: {with indicators, stains, dyes, tags, labels, marks}
- G01N 2201/06113: Coherent sources; lasers
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The present invention relates to a method for analyzing urine sample, a reagent for analysis of urine sample and a reagent kit for analysis of urine sample, which are for detecting at least casts and erythrocytes as urinary particles.

## Claims

### Claim 1

A method for analyzing a urine sample, comprising the steps of:
staining casts and erythrocytes in the urine sample with a fluorescent dye by mixing the urine sample with a first reagent containing the fluorescent dye, the fluorescent dye being at least one selected from the group consisting of 3,3′-diethyloxacarbocyanine iodide (DiOC2(3)), 3,3-dipropyloxacarbocyanine iodide (DiOC3(3)), 3,3′-dibutyloxacyanine iodide (DiOC4(3)) and 3,3-dipentyloxacarbocyanine iodide (DiOC5(3)),
dispersing aggregates of impurities in the urine sample with dodecyltrimethylammonium bromide by mixing a mixture of the urine sample and the first reagent with a second reagent containing dodecyltrimethylammonium bromide and obtaining a measurement sample,
obtaining scattered light information and fluorescence information by irradiating urinary particles contained in the measurement sample with light, and
detecting at least the casts and the erythrocytes as the urinary particles in the measurement sample based on the obtained scattered light information and fluorescence information.

### Claim 2 (depends on 1)

The method for analyzing the urine sample according to claim 1, wherein the second reagent further comprises a chelating agent.

### Claim 3 (depends on 2)

The method for analyzing the urine sample according to claim 2, wherein the chelating agent is ethylenediaminetetraacetate (EDTA) salt.

### Claim 4 (depends on 1)

The method for analyzing the urine sample according to claim 1, wherein the first reagent comprises a water-soluble organic solvent.

### Claim 5 (depends on 1)

The method for analyzing the urine sample according to claim 1, wherein the method further comprises a step of flowing the measurement sample through a flow cell.

### Claim 6 (depends on 1)

The method for analyzing the urine sample according to claim 1, wherein the scattered light information is scattered light intensity.

### Claim 7 (depends on 1)

The method for analyzing the urine sample according to claim 1, wherein the fluorescence information is fluorescence intensity.

### Claim 8 (depends on 1)

The method for analyzing the urine sample according to claim 1, wherein a concentration of the fluorescent dye in the measurement sample is more than or equal to 0.1 μg/mL and less than or equal to 200 μg/mL.

### Claim 9 (depends on 1)

The method for analyzing the urine sample according to claim 1, wherein a concentration of the fluorescent dye in the measurement sample is more than or equal to 1 μg/mL and less than or equal to 20 μg/mL.

### Claim 10 (depends on 1)

The method for analyzing the urine sample according to claim 1, wherein a pH of the second reagent is higher than or equal to 5 and lower than or equal to 9.

### Claim 11 (depends on 1)

The method for analyzing the urine sample according to claim 1, wherein a pH of the second reagent is higher than or equal to 6.5 and lower than or equal to 8.6.

### Claim 12 (depends on 1)

The method for analyzing the urine sample according to claim 1, wherein a pH of the second reagent is higher than or equal to 7.0 and lower than or equal to 7.8.

### Claim 13 (depends on 2)

The method for analyzing the urine sample according to claim 2, wherein a concentration of the chelating agent in the measurement sample is more than or equal to 0.1 mM and less than or equal to 500 mM.

### Claim 14 (depends on 2)

The method for analyzing the urine sample according to claim 2, wherein a concentration of the chelating agent in the measurement sample is more than or equal to 1 mM and less than or equal to 100 mM.