Chemistry: analytical and immunological testing – Hemoglobin – myoglobin – or occult blood – Glycosylated hemoglobin
Reexamination Certificate
2011-08-30
2011-08-30
Wallenhorst, Maureen M (Department: 1777)
Chemistry: analytical and immunological testing
Hemoglobin, myoglobin, or occult blood
Glycosylated hemoglobin
C436S063000, C436S066000, C436S124000, C436S164000, C436S166000, C436S174000, C435S023000, C435S028000
Reexamination Certificate
active
08008085
ABSTRACT:
A method of measuring HbA1c is provided that, even with a whole blood sample after storage, measurement accuracy substantially equal to a whole blood sample right after collection can be maintained. Whole blood is stored in a presence of a glycolytic inhibitor and protease is added to the stored whole blood sample to cleave hemoglobin in the whole blood sample. Then a glycated part of a hemoglobin fragment thereby obtained is treated with fructosyl amine oxidase. Thereafter, a glycation degree of HbA1c is determined by measuring a redox reaction between the glycated part and the fructosyl amine oxidase. Further, instead of storage of the whole blood in a presence of the glycolytic inhibitor, a strong electrolyte substance such as KCl, K2SO4, KNO, NaCl, Na2SO4, NaNO, MgCl2, MgSO4, Mg(NO)2, etc. is added to the whole blood after storage and a protease treatment is performed in a presence of the strong electrolyte substance. According to these methods, fluctuation in a measurement value of HbA1c due to storage of the whole blood can be avoided.
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Office Action issued in Chinese Application No. 200880003239.7 dated May 25, 2011.
Inamura Norio
Yonehara Satoshi
Arkray Inc.
Morgan & Lewis & Bockius, LLP
Wallenhorst Maureen M
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