Methods for determination of glycated haemoglobin

Abstract

The invention concerns a novel method for the determination of the ratio of glycated to non-glycated haemoglobin in a sample wherein (i) the sample is optionally haemolysed in order to release cell-bound haemoglobin, (ii) the sample is contacted with an excess of signal-generating molecules during which a fraction of thee signal-generating molecules binds to glycated haemoglobin in the sample, (iii) the fraction of signal-generating molecules that is not bound to glycated haemoglobin is separated from the sample, (iv) the signal-generating molecules are determined in the sample which contains signal-generating molecules bound to glycated haemoglobin as well as non-glycated haemoglobin as a measure for the glycated haemoglobin and the total amount of haemoglobin is determined, and (v) the ratio of glycated to non-glycated haemoglobin in the sample is determined from the values obtained according to step (iv). In addition the invention concerns an analytical test element which is suitable for determining the ratio of glycated to non-glycated haemoglobin in a sample by the new method according to the invention which contains next to and/or above one another a sample application zone a reagent zone in which non-immobilized signal-generating molecules are present and/or which contains the haemolysis reagents to release cell-bound haemoglobin, a separation zone for separating signal-generating molecules that are not bound to glycated haemoglobin and a detection zone, wherein The zones are located on or in one or several porous matrix materials and are in contact with one another enabling liquid transfer or can be brought into such a contact.

Dependencies are inferred from the claim text.