BLOOD ANALYSIS METHOD AND BLOOD TEST KIT

• US 20180128807A1
• Filed: 01/03/2018
• Published: 05/10/2018
• Est. Priority Date: 07/06/2015
• Status: Active Grant

• Current Assignee: Fujifilm Corporation (Fujifilm Holdings Corporation)
• Original Assignee: Fujifilm Corporation (Fujifilm Holdings Corporation)
• Inventors: ISHIZAKA, Tatsuya, NAKATSUGAWA, Haruyasu, OSAWA, Susumu, SUGIMOTO, Shinya
• Granted Patent: US 10,634,661 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150206 Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: G01N 1/10 in the liquid or fluent state burettes, pipettes B01L3/02; sampling of ground water E02D1/06; metering by volume of fluids or fluent solid material G01F11/00, G01F13/00
• CPC Class Codes: G01N 1/38 Diluting, dispersing or mixing samples
• CPC Class Codes: G01N 2333/765 Serum albumin, e.g. HSA
• CPC Class Codes: 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
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH
• CPC Class Codes: G01N 33/96 involving blood or serum control standard

Abstract

An object of the present invention is to provide a blood analysis method in which a high level of repeatability and reproducibility is achieved with respect to measurement values in a blood sample of 50 μL or less, and a blood test kit which is used for the blood analysis method. According to the present invention, a 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 the blood; and a step of analyzing a concentration of a target component in the blood sample, in which a volume of the blood sample is 50 μL or less, a dilution factor of blood plasma components in the blood sample is 14 or higher, and the diluent solution is a diluent solution which does not contain the normal component which is homeostatically present in the blood, is provided.

Claims

1. A blood analysis method, comprising:

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 the blood; and

a step of analyzing a concentration of a target component in the blood sample,

wherein a volume of the blood sample is 50 μ

L or less,

a dilution factor of blood plasma components in the blood sample is 14 or higher, and

the diluent solution is a buffer solution which does not contain the normal component which is homeostatically present in the blood, and

in the step of determining a dilution factor, a concentration of the normal component is measured by using a reagent for measuring the normal component.

2. The blood analysis method according to claim 1, further comprising:

a step of recovering a blood plasma components-containing specimen from the diluted blood sample, after the step of diluting the collected blood sample with the diluent solution.

3. The blood analysis method according to claim 2,

wherein the recovering step is a step in which a separation membrane is used.

4. The blood analysis method according to claim 2, further comprising:

a step of transporting the blood plasma components-containing specimen, after the step of recovering the blood plasma components-containing specimen from the diluted blood sample.

5. The blood analysis method according to claim 1,

wherein the normal component which is homeostatically present in the blood is sodium ions or chloride ions.

6. The blood analysis method according to claim 1,

wherein the normal component which is homeostatically present in the blood is sodium ions or chloride ions, and at least one normal component.

7. The blood analysis method according to claim 6,

wherein the at least one normal component is a normal component selected from total protein or albumins.

8. The blood analysis method according to claim 5,

wherein the diluent solution is a diluent solution which does not contain sodium ions or chloride ions.

9. The blood analysis method according to claim 5,

wherein the normal component which is homeostatically present in the blood is sodium ions.

10. The blood analysis method according to claim 9,

wherein the diluent solution is a diluent solution which does not contain sodium ions.

11. The blood analysis method according to claim 1,

wherein the diluent solution is a buffer solution having a buffering action within a pH range of pH 6.5 to pH 8.0.

12. The blood analysis method according to claim 1,

wherein the diluent solution is a diluent solution including an amino alcohol compound selected from the group consisting of 2-amino-2-methyl-1-propanol, 2-ethylaminoethanol, N-methyl-D-glucamine, diethanolamine, and triethanolamine, and including a buffering agent selected from the group consisting of 2-[4-(2-hydroxyethyl)-1-piperazinyl]ethanesulfonic acid also called HEPES, N-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid also called TES, 3-morpholinopropanesulfonic acid also called MOPS, and N,N-bis(2-hydroxyethyl)-2-aminoethanesulfonic acid also called BES.

13. The blood analysis method according to claim 1, further comprising:

a step of verifying the analysis of a concentration of the target component by using a dilution factor obtained from a normal value of a normal component other than the above normal component.

14. A blood test kit which is used for the blood analysis method according to claim 1, the kit comprising:

a diluent solution for diluting a blood sample; and

a container for storing the diluted blood sample.