The present application provides a micro red blood cell collection device for detecting glycosylated hemoglobin. By using the device, the extraction of packed red blood cells can be realized on one device by providing structures such as a blood-absorbing pad and a porous adhesive layer. The present application provides a method for collecting micro red blood cells. In the method, by using the device as a collection device, the micro red blood cells can be collected directly from the blood sample, thereby solving the defect of complicated operations required for sampling in the prior art. The present application provides a method for detecting glycosylated hemoglobin. In the method, by using the device to collect packed red blood cells and further directly detect glycosylated hemoglobin, the technical problem of inconvenient operation in the detection of glycosylated hemoglobin caused by the combined use of multiple devices in the prior art is solved.

A method for determining the amount of glycated hemoglobin (HbA1c), in whichif requiredthe erythrocytes in a sample are hemolyzed, the haemoglobin that is then releasedif requiredis 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.

A system for determining a concentration of hemoglobin A1C includes a first electrochemical test strip, the first electrochemical test strip providing for an HbA1C concentration; and a second electrochemical test strip, the second electrochemical test strip providing for the total amount of hemoglobin.

Methods and kits-of-parts for determining the quantity of HbA1c relative to the concentration of haemoglobin in a blood sample comprising less than 200 l, the method including the steps of adding the fluorophore to the sample and measuring the fluorescence at one or more time points within the time interval, at which the change in fluorescence over time is >0, followed by measurements of haemoglobin by adding a haemoglobin-binding agent and measuring the change in transmission at approximately 570 nm and comparing the obtained results with an internal standard.

Hemoglobin, its variants, and glycated forms of each are determined individually in a multiplex assay that permits correction of the measured level of HbA1c to account for glycated variants and other factors related to the inclusion of the variants in the sample. New antibodies that are particularly well adapted to the multiplex assay are also provided.

This invention provides an amadoriase having improved specific activity on a glycated substrate, compared with conventional amadoriase. Provided is an amadoriase comprising a substitution of the amino acid at the position corresponding to position 64 of the amino acid sequence as shown in SEQ ID NO: 1 with an amino acid selected from the group consisting of glycine, serine, methionine, leucine, threonine, valine, and isoleucine, a method for measurement of HbA1c, and a reagent kit for measurement of HbA1c using such amadoriase. Such method and kit for measurement enable rapid, simple, and accurate quantification of HbA1c.

The method describes rapid screening of whole blood samples, pin prick and blood spot cards, subjected to MALDI-ToF Mass spectrometry. The spectra is generated and compared to those from normal healthy controls. Characteristic spectra are indicative of the presence of a hemoglobinopathy and the method can be used to screen/diagnose all sickle cell diseases, alpha and beta Thalassemias.

A method includes estimating a value of a parameter indicative of an age or lifespan of a population of red blood cells of a subject, estimating a value of average glucose (AG) of the subject based on (i) the value of the parameter and (ii) a value indicative of an amount of glycated hemoglobin (HbA1c) of the subject, and providing information for treatment or diagnosis of a hyperglycemia condition of the subject based on the estimated value of AG.

Sensors for target entities having functionalized thereon, at least one aptamer specific to the target entity, and methods of making and using the same are described for use in glycated protein monitoring and/or biomarkers.

The invention relates to a method for analysis by capillary electrophoresis of glycated haemoglobins comprising at least one globin chain comprising a glucose residue bound to the amino acid in the N-terminal position, contained in a biological sample, said method comprising using a buffer composition comprising at least one compound which is capable of specifically complexing glucose residues of one or several glycated haemoglobin(s) and of providing said glycated haemoglobin(s) with several negative electric charges at an alkaline pH. By way of example, this compound may be 3,4- or 3,5-dicarboxyphenylboronic acid, preferably 3,5-dicarboxyphenylboronic acid. Said method may in particular be used to separate and assay haemoglobin HbA.sub.1c present in a biological sample optionally comprising other haemoglobins, in particular other minor fractions. The invention also concerns buffer compositions for use in said analysis, as well as kits for the analysis and for the assay of glycated haemoglobins by capillary electrophoresis.