The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Feb. 12, 2019

Filed:

Mar. 31, 2015
Applicant:

Diasys Diagnostic Systems Gmbh, Holzheim, DE;

Inventors:

Günther Gorka, Bad Camberg, DE;

Yoshifumi Watazu, Kobe, JP;

Erwin Metzmann, Marburg, DE;

Alexandra Lein, Diez, DE;

Holger Müller, Diez, DE;

Matthias Grimmler, Elz, DE;

Assignee:
Attorney:
Primary Examiner:
Int. Cl.
CPC ...
C12Q 1/28 (2006.01); G01N 33/72 (2006.01); C12Q 1/26 (2006.01); C12Q 1/37 (2006.01); C12N 9/64 (2006.01);
U.S. Cl.
CPC ...
C12Q 1/28 (2013.01); C12N 9/6491 (2013.01); C12Q 1/26 (2013.01); C12Q 1/37 (2013.01); C12Y 105/03 (2013.01); C12Y 304/24027 (2013.01); G01N 33/723 (2013.01); G01N 33/725 (2013.01); C12Q 2326/00 (2013.01); G01N 2333/805 (2013.01); G01N 2333/90672 (2013.01); G01N 2333/954 (2013.01);
Abstract

A method for determining the amount of glycated hemoglobin (HbA1c), in which—if required—the erythrocytes in a sample are hemolyzed, the haemoglobin that is then released—if required—is contacted with a proteolytic agent and the glycated hemoglobin degradation products obtained in this way or otherwise are quantified is disclosed. In order to provide such a process and reagents employable therein that has/have the property of sufficient stability of the chemical compounds that are essential to the reaction, the provision of the requisite proteolytic agent in the form of an inactivated protease is proposed, which is then only reactivated in situ. For the stabilization of the hemoglobin, which is unfolded at a very low pH in the range from 1 to 3, at least one suitable stabilizer should be present in the hemolysis solution, and, where a leuco dye is used in connection with the determination of the amount of HbA1c, it is proposed that the latter be stabilized with particular phosphine compounds and/or thio compounds.


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