Methods and test devices for determination of glycated haemoglobin

US6399293B1 · kind B1 · utility

Assignee

• Roche Diagnostics GMBH · DE

Inventors

• Rudolf Pachl · Ellerstadt, DE
• Carina Horn · Biblis, DE

Key dates

• Filing date: Sep 13, 1999
• Grant date: Jun 4, 2002
• Expiry date: Sep 13, 2019

Classification

• Technology area (CPC Y): Emerging Cross-Sectional Technologies
• CPC primary: Y10T436/25375
• WIPO field: Measurement
• WIPO sector: Instruments

Abstract

This invention relates to a test element and a method for determining the ratio of glycated to non-glycated haemoglobin in a sample, for example, in a blood sample that is provided as a fresh sample, a dried sample or a haemolysed sample. The test element can include different zones for receiving the sample, serving as a depot for reagents such as non-immobilized signal-generating molecules or haemolysis reagents, separating reagents from the sample, and detecting heamoglobin. The zones are provided on a porous matrix and in fluid contact with each other. The method uses the test element and determines the ratio of glycated to non-glycated haemoglobin in a sample, by contacting the sample with an excess of signal generating molecules to bind to the glycated haemoglobin. The non-bound signal generating molecules are separated from the sample, and the amount or concentration of haemoglobin and/or glycated haemoglobin bound signal generating molecules are determined. The signal generating molecules can be selected to be a direct label, an enzyme label or a radiolabel, which can be attached to the glycated haemoglobin via a boronic acid group or another specific binding partner or anti…