# US 2024/0201206 A1 · METHOD FOR ESTIMATING HEMOGLOBIN A1c LEVEL, INFORMATION PROCESSING APPARATUS, AND COMPUTER-READABLE STORAGE MEDIUM

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- Number: US 2024/0201206 A1
- Document ID: US20240201206A1
- Status: Published application
- Kind: A1
- Application number: 18/539,696
- Filed: 2023-12-14
- Published: 2024-06-20
- Earliest claimed: 2022-12-16
- Assignees: ARKRAY, Inc.
- Applicants: ARKRAY, Inc.
- Inventors: Kazuki ISHIKAWA
- Web page: https://patentgrep.com/patent/US20240201206A1

## 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 33/721: {Haemoglobin}
- G01N 30/8631: {Peaks}
- G01N 30/8679: {Target compound analysis, i.e. whereby a limited number of peaks is analysed}
- G01N 33/723: {Glycosylated haemoglobin}
- G16B 40/10: Signal processing, e.g. from mass spectrometry [MS] or from PCR
- G16B 50/30: Data warehousing; Computing architectures
- G01N 2030/027: {Liquid chromatography}
- G01N 2030/8822: {involving blood}
- G01N 2333/805: Haemoglobins; Myoglobins
- 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)
- G16B: BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY

## Abstract

Provided is a method for estimating a hemoglobin A1c level including acquiring in advance a correlation between a hemoglobin A1c level which is based on the ratio of the peak value of a hemoglobin A1c peak to the total of the peak values related to hemoglobin A and a glycated mutant hemoglobin level which is based on the ratio of the peak value of a glycated mutant hemoglobin peak to the total of the peak values containing mutant hemoglobin and the peak value of the glycated mutant hemoglobin peak containing glycated mutant hemoglobin formed by glycating the mutant hemoglobin, from a chromatogram of a blood specimen that contains the hemoglobin A and the mutant hemoglobin, deriving a glycated mutant hemoglobin level from a chromatogram of a blood specimen, and estimating a hemoglobin A1c level based on the derived glycated mutant hemoglobin level and the correlation.

## Claims

### Claim 1

A method for estimating a hemoglobin A1c level, the method comprising:
acquiring in advance a correlation between a hemoglobin A1c level which is a value based on the ratio of the peak value of a hemoglobin A1c peak containing hemoglobin A1c to the total value of the peak values of peaks related to hemoglobin A and a glycated mutant hemoglobin level which is a value based on the ratio of the peak value of a glycated mutant hemoglobin peak to the total value of the peak value of a peak containing mutant hemoglobin and the peak value of the glycated mutant hemoglobin peak containing glycated mutant hemoglobin formed by glycating the mutant hemoglobin, from a chromatogram obtained by subjecting a blood specimen containing the hemoglobin A and the mutant hemoglobin that is collected from each of a plurality of subjects to liquid chromatography;
deriving a glycated mutant hemoglobin level from a chromatogram obtained by subjecting a blood specimen which is a measurement target collected from a subject having the mutant hemoglobin to liquid chromatography; and
estimating a hemoglobin A1c level based on the derived glycated mutant hemoglobin level and the correlation.

### Claim 2 (depends on 1)

The method for estimating a hemoglobin A1c level according to claim 1, wherein
the mutant hemoglobin is hemoglobin C.

### Claim 3 (depends on 2)

The method for estimating a hemoglobin A1c level according to claim 2, wherein
a glycated hemoglobin C level is obtained as a value based on the ratio of the peak value of a peak X, which appears between a peak containing hemoglobin A0 and a hemoglobin C peak containing hemoglobin C in the chromatogram, to the total value of the peak value of the peak X and the peak value of the hemoglobin C peak and used as the glycated mutant hemoglobin level.

### Claim 4 (depends on 3)

The method for estimating a hemoglobin A1c level according to claim 3, wherein
the liquid chromatography is cation exchange chromatography.

### Claim 5

An information processing apparatus comprising:
a storage unit storing a correlation between a hemoglobin A1c level which is a value based on the ratio of the peak value of a hemoglobin A1c peak containing hemoglobin A1c to the total value of the peak values of peaks related to hemoglobin A and a glycated mutant hemoglobin level which is a value based on the ratio of the peak value of a glycated mutant hemoglobin peak to the total value of the peak value of a peak containing mutant hemoglobin and the peak value of the glycated mutant hemoglobin peak containing glycated mutant hemoglobin formed by glycating the mutant hemoglobin, the correlation being obtained from a chromatogram obtained by subjecting a blood specimen containing the hemoglobin A and the mutant hemoglobin that is collected from each of a plurality of subjects to liquid chromatography;
an acquisition unit acquiring a glycated mutant hemoglobin level obtained from a chromatogram obtained by subjecting a blood specimen which is a measurement target collected from a subject having the mutant hemoglobin to liquid chromatography;
a calculation unit calculating an estimated value of a hemoglobin A1c level based on the glycated mutant hemoglobin level acquired by the acquisition unit and the correlation stored in the storage unit; and
an output unit outputting the estimated value.

### Claim 6

A non-transitory computer-readable storage medium storing an estimation program which causes a computer that stores a correlation between a hemoglobin A1c level which is a value based on the ratio of the peak value of a hemoglobin A1c peak containing hemoglobin A1c to the total value of the peak values of peaks related to hemoglobin A and a glycated mutant hemoglobin level which is a value based on the ratio of the peak value of a glycated mutant hemoglobin peak to the total value of the peak value of a peak containing mutant hemoglobin and the peak value of the glycated mutant hemoglobin peak containing glycated mutant hemoglobin formed by glycating the mutant hemoglobin, the correlation being obtained from a chromatogram obtained by subjecting a blood specimen containing the hemoglobin A and the mutant hemoglobin that is collected from each of a plurality of subjects to liquid chromatography, to execute processing of:
acquiring a glycated mutant hemoglobin level obtained from a chromatogram obtained by subjecting a blood specimen which is a measurement target collected from a subject having the mutant hemoglobin to liquid chromatography,
calculating an estimated value of a hemoglobin A1c level based on the acquired glycated mutant hemoglobin level and the stored correlation, and
outputting the estimated value.