Leucine-rich ALPHA2 glycoprotein composition

Patent metadata

Field	Value
Publication number	US-12331092-B2
Application number	US-201917282325-A
Country	US
Kind code	B2
Filing date	Oct 8, 2019
Priority date	Oct 9, 2018
Publication date	Jun 17, 2025
Grant date	Jun 17, 2025

Abstract

An object is to provide a leucine-rich α2 glycoprotein composition comprising leucine-rich α2 glycoprotein and having excellent preservation stability. The object can be achieved by a leucine-rich α2 glycoprotein composition comprising leucine-rich α2 glycoprotein and having a pH of 7.0 to 9.3.

First claim

The invention claimed is:

1. A leucine-rich α2 glycoprotein solution, comprising:
leucine-rich α2 glycoprotein;
a preservative;
a glycoprotein other than LRG, or a peptide;
a non-ionic surfactant;
a buffer;
a metal salt;
and
water,
wherein pH of the solution is 7.8 to 9.0,
concentration of the metal salt of the solution is 300 mM to 600 mM,
90% or more of the leucine-rich α2 glycoprotein contained in the solution containing the leucine-rich α2 glycoprotein is maintained without being decomposed or without a structural change for 29 days at 37° C., and
said solution is suitable for use as a calibration sample solution for measuring leucine-rich α2 glycoprotein.

2. The leucine-rich α2 glycoprotein solution according to claim 1 , which is filled in a preservation container.

3. The leucine-rich α2 glycoprotein solution according to claim 1 , wherein 95% or more of the leucine-rich α2 glycoprotein contained in the solution containing the leucine-rich α2 glycoprotein is maintained without being decomposed or without a structural change for 29 days at 37° C.

4. The leucine-rich α2 glycoprotein solution according to claim 1 , wherein 96% or more of the leucine-rich α2 glycoprotein contained in the solution containing the leucine-rich α2 glycoprotein is maintained without being decomposed or without a structural change for 29 days at 37° C.

5. The leucine-rich α2 glycoprotein solution according to claim 1 , wherein said metal salt is a sodium salt.

6. The leucine-rich α2 glycoprotein solution according to claim 5 , wherein said sodium salt is sodium chloride.

7. A kit comprising:
(1) the leucine-rich α2 glycoprotein solution according to claim 1 , the solution containing a peptide and further containing an amino acid and a saccharide, and
(2) a buffer, a stabilizing agent, a specimen diluent, a pH adjustment agent, and a reaction container.

8. The kit according to claim 7 , said solution further comprising a polymer.

9. The kit according to claim 7 , said solution further comprising a polyethylene glycol, polyvinylpyrrolidone or a phospholipid polymer.

10. The leucine-rich α2 glycoprotein solution according to claim 1 , wherein the glycoprotein other than LRG or the peptide is albumin or casein.

Assignees

• Sekisui Medical Co Ltd
• Nat Inst Biomedical Innovation Health & Nutrition

Inventors

• Takayama Shigeo
• Naka Tetsuji
• Serada Satoshi

Classifications

• G01N33/6803

  General methods of protein analysis not limited to specific proteins or families of proteins · CPC title

• G01N33/68

  involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)} · CPC title

• G01N2400/00

  Assays, e.g. immunoassays or enzyme assays, involving carbohydrates · CPC title

• G01N33/6893

  related to diseases not provided for elsewhere · CPC title

• G01N33/52

  Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper {and including single- and multilayer analytical elements (immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72)} · CPC title