# US 2025/0155445 A1 · Method for examining blood sample

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- Number: US 2025/0155445 A1
- Document ID: US20250155445A1
- Status: Published application
- Kind: A1
- Application number: 18/728,606
- Filed: 2023-01-11
- Published: 2025-05-15
- Earliest claimed: 2022-01-13
- Assignees: Provigate Inc.
- Applicants: Provigate Inc.
- Inventors: Mitsumi NISHI; Noriko MIYAUCHI; Tomoko IRIE
- Web page: https://patentgrep.com/patent/US20250155445A1

## CPC

- G01N 33/49: Blood {(chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80)}
- G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)}
- G01N 30/88: Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
- G01N 33/6827: {Total protein determination, e.g. albumin in urine}
- G01N 33/80: involving blood groups or blood types {or red blood cells (white blood cells G01N33/56972)}
- G01N 2030/8822: {involving blood}
- G01N 2333/76: Assays involving albumins other than in routine use for blocking surfaces or for anchoring haptens during immunisation
- G01N 2333/765: Serum albumin, e.g. HSA
- G01N 2440/38: addition of carbohydrates, e.g. glycosylation, glycation
- 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

In an embodiment of the present disclosure, a method for testing a blood sample is provided. The method includes determining whether subject blood is hemolyzed; and, if it is determined that the subject blood is hemolyzed, testing the subject blood with a test instrument that is responsive to hemolysis.

## Claims

### Claim 1

A method for testing a blood sample, the method comprising:
providing subject blood;
providing a hemolysis-responsive test instrument and a non-hemolysis-responsive test instrument;
determining whether the subject blood is hemolyzed; and
if determined that the subject blood is not hemolyzed, performing a test with the non-hemolysis-responsive test instrument, the test comprising a measurement of glycated albumin present in the subject blood, or if determined that the subject blood is hemolyzed, performing a test with the hemolysis-responsive test instrument, the test comprising a measurement of glycated albumin present in the subject blood.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the hemolysis-responsive test instrument and the non-hemolysis-responsive test instrument are each a diabetes test instrument.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the hemolysis-responsive test instrument is a high-performance liquid chromatography (HPLC) instrument, and the non-hemolysis-responsive test instrument is an absorbance spectrometer.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the determining whether the subject blood is hemolyzed comprises:
performing an absorbance measurement on the subject blood; and
determining, based on a difference in an absorbance between the subject blood and a control sample, whether the subject blood is hemolyzed.

### Claim 5

(canceled)

### Claim 6 (depends on 1)

The method according to claim 1, further comprising:
measuring a protein present in the subject blood; and
adjusting, based on a result of the measured protein, one or both of a measurement condition for a test that uses the hemolysis-responsive test instrument and a measurement condition for a test that uses the non-hemolysis-responsive test instrument.

### Claim 7 (depends on 6)

The method according to claim 6, wherein the condition for the test that uses the hemolysis-responsive test instrument includes a dilution ratio for diluting the subject blood for an HPLC method.

### Claim 8 (depends on 1)

The method according to claim 1, further comprising measuring an amount of the subject blood.

### Claim 9 (depends on 8)

The method according to claim 8, wherein if the amount of the subject blood is less than a predetermined amount, the method comprises testing the subject blood with the hemolysis-responsive test instrument.

### Claim 10 (depends on 8)

The method according to claim 8, wherein if the amount of the subject blood is less than a predetermined amount, the method comprises instructing a subject to have blood drawn again, notifying the subject that there is a possibility that the testing does not provide correct results, and/or providing an instruction or a notification to a person in charge of the measurement, the instruction and the notification requiring the condition for the test to be adjusted.

### Claim 11 (depends on 1)

The method according to claim 1, further comprising measuring a turbidity of the subject blood.

### Claim 12 (depends on 11)

The method according to claim 11, further comprising determining, based on the measured turbidity, that the testing is to be performed by the hemolysis-responsive test instrument, determining that the testing is to be performed by the non-hemolysis-responsive test instrument, or determining that a measurement is not to be performed.

### Claim 13 (depends on 1)

A facility for implementing the method for testing a blood sample according to claim 1, the facility comprising:
a hemolysis-responsive test instrument;
a non-hemolysis-responsive test instrument; and
a computer system configured to be communicably connected to the hemolysis-responsive test instrument and the non-hemolysis-responsive test instrument.

### Claim 14 (depends on 13)

The facility for implementing the method for testing a blood sample according to claim 13, wherein the hemolysis-responsive test instrument is configured to determine whether the subject blood is hemolyzed.

### Claim 15 (depends on 13)

The facility for implementing the method for testing a blood sample according to claim 13, further comprising a hemolysis determination instrument.

### Claim 16 (depends on 13)

The facility for implementing the method for testing a blood sample according to claim 13, further comprising a robot that is configured to transfer the blood sample between the instruments and is communicable with the computer system.

### Claim 17 (depends on 16)

The facility for implementing the method for testing a blood sample according to claim 16, wherein the computer system is configured to
cause the robot to transfer the provided blood sample to the hemolysis-responsive test instrument or the hemolysis determination instrument;
instruct the hemolysis-responsive test instrument or the hemolysis determination instrument to make a determination regarding hemolysis of the blood sample;
receive a result of the determination regarding hemolysis, and select which of the hemolysis-responsive test instrument and the non-hemolysis-responsive test instrument is to be used to test the blood sample;
instruct the robot to transfer the blood sample to the selected test instrument;
instruct the selected test instrument to perform a test on the transferred blood sample; and
receive a result of the test of the blood sample and output the result of the test.

### Claim 18 (depends on 16)

The facility for implementing the method for testing a blood sample according to claim 16, wherein the computer system is configured to
instruct the facility to transfer the provided blood sample to the hemolysis-responsive test instrument or the hemolysis determination instrument;
instruct the hemolysis-responsive test instrument or the hemolysis determination instrument to make a determination regarding hemolysis of the blood sample;
receive a result of the determination regarding hemolysis, and select which of the hemolysis-responsive test instrument and the non-hemolysis-responsive test instrument is to be used to test the blood sample;
instruct the facility to transfer the blood sample to the selected test instrument;
instruct the selected test instrument to perform a test on the transferred blood sample; and
receive a result of the test of the blood sample and output the result of the test.

### Claim 19 (depends on 17)

A program for performing an operation of the computer system according to claim 17.
