Glycated hemoglobin (%) assay method

Patent metadata

Field	Value
Publication number	US-2021389306-A1
Application number	US-201917277912-A
Country	US
Kind code	A1
Filing date	Sep 27, 2019
Priority date	Sep 28, 2018
Publication date	Dec 16, 2021
Grant date	—

Abstract

A problem to be solved is to provide a glycated hemoglobin (%) assay method and assay reagent capable of accurate measurement of glycated hemoglobin (%) in blood even when a blood specimen containing hemoglobin contains abnormal hemoglobin such as HbS or HbC.
The present invention provides a method capable of accurate measurement of glycated hemoglobin (%) in blood even in a specimen containing abnormal hemoglobin by combining two types of monoclonal antibodies, i.e., an anti-glycated hemoglobin monoclonal antibody and a monoclonal antibody to the anti-glycated hemoglobin monoclonal antibody, and an assay reagent for performing the method.

First claim

1 - 15 . (canceled)

16 . A glycated hemoglobin (%) assay method for measuring glycated hemoglobin (%) in a sample in a liquid, comprising steps of:
adsorbing the glycated hemoglobin in the sample to an insoluble carrier by bringing the sample into contact with the insoluble carrier contained in a buffer solution; forming a complex of an anti-glycated hemoglobin monoclonal antibody, the glycated hemoglobin, and the insoluble carrier by bringing the glycated hemoglobin adsorbed to the insoluble carrier into contact with the anti-glycated hemoglobin monoclonal antibody; and agglutinating the insoluble carrier in the liquid by bringing the complex into contact with a monoclonal antibody reacting with the anti-glycated hemoglobin monoclonal antibody and not reacting with human IgG.

17 . The glycated hemoglobin (%) assay method according to claim 16 , wherein the insoluble carrier is latex.

18 . The glycated hemoglobin (%) assay method according to claim 16 , wherein the sample is whole blood or blood cells.

19 . The assay method according to claim 16 , comprising a step of optically detecting a degree of agglutination.

20 . A glycated hemoglobin (%) assay reagent comprising: at least a buffer solution containing an insoluble carrier and following two types of monoclonal antibodies:
1) an anti-glycated hemoglobin monoclonal antibody; and 2) a monoclonal antibody reacting with the anti-glycated hemoglobin monoclonal antibody and not reacting with human IgG.

21 . The glycated hemoglobin (%) assay reagent according to claim 20 , comprising a first reagent and a second reagent, wherein
the first reagent contains the buffer solution containing the insoluble carrier, and wherein the second reagent contains at least following two types of monoclonal antibodies: 1) the anti-glycated hemoglobin monoclonal antibody; and 2) the monoclonal antibody reacting with the anti-glycated hemoglobin monoclonal antibody and not reacting with human IgG.

22 . The glycated hemoglobin (%) assay reagent according to claim 20 , wherein the insoluble carrier is latex.

23 . A glycated hemoglobin (%) assay kit comprising: the glycated hemoglobin (%) assay reagent according to claim 20 .

24 . A monoclonal antibody reacting with a monoclonal antibody bound to human glycated hemoglobin and not reacting with human IgG.

25 . A method for reducing a deviation of a measurement value of glycated hemoglobin (%) in a sample containing abnormal hemoglobin, the method comprising a step of bringing at least following two types of monoclonal antibodies, a buffer solution containing an insoluble carrier, and the sample into contact with each other:
1) an anti-glycated hemoglobin monoclonal antibody; and 2) a monoclonal antibody reacting with the anti-glycated hemoglobin monoclonal antibody and not reacting with human IgG.

26 . A method for suppressing a false high value in measurement value of glycated hemoglobin (%) in a sample containing abnormal hemoglobin, the method comprising a step of bringing at least following two types of monoclonal antibodies, a buffer solution containing an insoluble carrier, and the sample into contact with each other:
1) an anti-glycated hemoglobin monoclonal antibody; and 2) a monoclonal antibody reacting with the anti-glycated hemoglobin monoclonal antibody and not reacting with human IgG.

27 . A method for reducing a deviation or suppressing a false high value of a measurement value of glycated hemoglobin (%) in a sample possibly containing abnormal hemoglobin, comprising steps of:
adsorbing the glycated hemoglobin in the sample to an insoluble carrier by bringing the sample into contact with the insoluble carrier contained in a buffer solution; forming a complex of an anti-glycated hemoglobin monoclonal antibody, the glycated hemoglobin, and the insoluble carrier by bringing the glycated hemoglobin adsorbed to the insoluble carrier into contact with the anti-glycated hemoglobin monoclonal antibody; and agglutinating the insoluble carrier in a liquid by bringing the complex into contact with a monoclonal antibody reacting with the anti-glycated hemoglobin monoclonal antibody and not reacting with human IgG.

Assignees

• Sekisui Medical Co Ltd

Inventors

• Ota Mieko
• Miyazaki Osamu
• SEO Satoko
• Yamamoto Mitsuaki
• Nishio Tomohisa

Classifications

• C07K16/44

  against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids} · CPC title

• G01N33/545

  Synthetic resin · CPC title

• G01N33/723 Primary

  Glycosylated haemoglobin · CPC title

• C07K2317/34

  Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues · CPC title

• G01N33/536 Primary

  with immune complex formed in liquid phase · CPC title