# US 11,442,070 B2 · Blood analysis method and blood test kit

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- Number: US 11,442,070 B2
- Document ID: US11442070B2
- Status: Granted
- Kind: B2
- Application number: 16/454,064
- Filed: 2019-06-27
- Published: 2019-10-17
- Granted: 2022-09-13
- Earliest claimed: 2016-12-28
- Assignees: FUJIFILM Corporation
- Applicants: FUJIFILM Corporation
- Inventors: Kota Fukui; Shinya Sugimoto; Isao Yonekubo
- Web page: https://patentgrep.com/patent/US11442070B2

## CPC

- G01N 33/48: Biological material, e.g. blood, urine (G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence); Haemocytometers (counting blood corpuscules distributed over a surface by scanning the surface G06M11/02)
- G01N 33/721: {Haemoglobin}
- G01N 1/38: Diluting, dispersing or mixing samples
- G01N 33/491: {by separating the blood components (G01N15/05 takes precedence)}
- G01N 33/96: involving blood or serum control standard
- 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

An object of the present invention is to provide a blood analysis method and a blood test kit, which are capable of performing measurement of a plurality of target components to be analyzed with high accuracies in a case where hemolysis occurs in a case of measuring an amount of target components to be analyzed in a small volume of a blood sample. According to the present invention, provided is a blood analysis method for measuring a concentration of a target component to be analyzed, the blood analysis method including: a step of diluting a collected blood sample with a diluent solution, a step of determining a dilution factor by using a normal value of a normal component which is homeostatically present in blood, a step of analyzing the concentration of the target component to be analyzed in the blood sample, measuring an amount of hemolysis in the blood sample, correcting the dilution factor according to the measured amount of hemolysis, and analyzing the concentration of the target component to be analyzed using the corrected dilution factor.

## Claims

### Claim 1

A blood analysis method for measuring a concentration of a target component to be analyzed, the blood analysis method comprising:
a step of diluting a collected blood sample with an aqueous diluent solution;
a step of determining a dilution factor by comparing a normal value of a first normal component which is homeostatically present in blood with a measured concentration value of the first normal component in the blood sample diluted with the diluent solution, wherein the normal value is an average homeostatic concentration value of the first normal component in blood plasma; and
a step of analyzing the concentration of the target component to be analyzed in the blood sample,
wherein the diluent solution does not contain the first normal component which is homeostatically present in blood as a component and the method performs
measuring an amount of hemolysis in the blood sample,
determining a correction factor based on a predetermined relationship between the amount of hemolysis in the blood sample and a variation in detected concentration of the first normal component in the blood plasma caused by hemolysis,
correcting the dilution factor according to the correction factor, and
analyzing the concentration of the target component to be analyzed using the corrected dilution factor,
wherein the first normal component is one or more of sodium ions, potassium ions, and total proteins.

### Claim 2 (depends on 1)

The blood analysis method according to claim 1, which is performed by using a blood test kit,
wherein the blood test kit includes
the diluent solution for diluting the blood sample,
a separating membrane for recovering a blood plasma component from the diluted blood sample; and
a container for storing the blood plasma component recovered from the diluted blood sample.

### Claim 3 (depends on 2)

The blood analysis method according to claim 2,
wherein the diluent solution contains a second normal component not present in blood,
the second normal component not present in blood is one or more of glycerol 3-phosphate, an alkali metal, or an alkaline earth metal,
another dilution factor is evaluated by comparing a concentration value of the second normal component not present in blood in the diluent solution with the concentration value of the first normal component which is homeostatically present in blood in the blood sample diluted with the diluent solution, and
the concentration of the target component to be analyzed in the blood sample is evaluated using the corrected dilution factor.

### Claim 4 (depends on 2)

The blood analysis method according to claim 2,
wherein the blood plasma component is recovered from the diluted blood sample by using the blood test kit,
a dilution factor of the diluted blood sample is determined using the first normal component which is homeostatically present in the recovered blood plasma component, and
the concentration of the target component to be analyzed in the blood sample is analyzed.

### Claim 5 (depends on 2)

The blood analysis method according to claim 2,
wherein the diluent solution contains a second normal component not present in blood,
the second normal component not present in blood is one or more of glycerol 3-phosphate, an alkali metal, or an alkaline earth metal, and
another dilution factor of the diluted blood sample is determined using the second normal component not present in blood, the concentration of the target component to be analyzed in the blood sample is analyzed using the corrected dilution factor.

### Claim 6 (depends on 3)

The blood analysis method according to claim 3, wherein the alkali metal is lithium, rubidium, cesium, or francium, and
the alkaline earth metal is strontium, barium, or radium.

### Claim 7 (depends on 5)

The blood analysis method according to claim 5, wherein the alkali metal is lithium, rubidium, cesium, or francium, and
the alkaline earth metal is strontium, barium, or radium.
