Downloads. Package insert Spanish Lot: – Expiry: 05/ Ed. 8; Package insert French Lot: – Expiry: 05/ Ed. 8; Package insert . Summary [1, 2]. Hemoglobin A1c (HbA1c) is a glycated hemoglobin which is formed by the non-enzymatic reaction of glucose with native hemoglobin. HbA1c FS*. Diagnostic reagent for quantitative in vitro determination of hemoglobin A1c (HbA1c) in whole blood on. DiaSys responsĀ® Order Information.

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Besides stabilisation of the protease the inventors of the present invention also set themselves the object of being able to unfold the haemoglobin contained in a sample, including HbA1c, as greatly as possible, and stabilise it in that unfolded form in order for example to permit digestion of the utmost efficiency of the haemoglobin by a protease and to put the haemoglobin into a measurable photometrically stable form.

In vivo, ex vivo and in vitro regenerated cartilage. The combination of a substance in accordance with formula IV with a further thio compound from the group of thioketones, thioethers or thioalcohols is particularly suitable as optimum stabilisation of the leuco dye over a long period of time up to 24 months can be ensured when using the respectively individual redox potentials and the different stability and reactivity of the specified thio compounds in aqueous solutions.

In the cases in which the stabilizer includes a zwitterionic detergent which has a haemolytic action or comprises one or more haemolytically acting zwitterionic detergents various variants are possible: A reagent kit for use in a method of determining the amount of glycated haemoglobin HbA1c in a sample, wherein the reagent kit includes at least the following solutions in separate containers: According to the invention it is therefore proposed, for optimisation of the actual HbA1c detection reaction, that the SH groups which disturb that reaction are blocked by the addition of an SH group-trapping agent like for example N-ethylmaleinimide NEM.

Table 2 C shows the AmE loss of the individual calibrators under different storage conditions. Further examples of leuco dyes suitable for the present invention are the diphenylamine derivatives described in EP, EP and EP In general the present invention however does not require any specificity of the protease in regard to differentiation between glycated and non-glycated haemoglobin.

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Examples of chelators for divalent metal ions, that are suitable in accordance with the present invention, are acetylacetone, hbq1c acid NTAethylenediamine, ethylenediamine tetraacetate EDTAN- 2-hydroxyethyl -ethylenediamine-N.

Changing from Glucose to HbA1c for Diabetes Diagnosis

At the present time 54 metalloprotease families are divided into 15 clans, wherein outstanding significance is attributed to the clan MA with 39 families. The addition of the SH group-trapping agent should accordingly occur at latest immediately prior to carrying out the HbA1c detection reaction. Examples of such thio compounds are thiodiglycol, thiomalic acid, thionicotinamide, thio-NAD and mixtures thereof without any limitation of the invention being intended thereby as a result of specifying those examples.

The above-mentioned thio compounds can be used either alone or in combination with the compounds referred to hereinbefore of general formula I. In addition for the major part leuco dyes have such high absorption maxima that optical influencing by interaction with constituents of the blood like for example bilirubin and haemoglobin can generally be disregarded. To resolve that problem the state of the art proposed for example for the protease thermolysin removing zinc from the theremolysin by chelators, in particular SH group-containing reagents, or by a simple excess of EDTA.

The released glycated haemoglobin is then brought into contact with a proteolytic agent to produce glycated haemoglobin degradation products.

Ultimately, determination of the HbA1c content is effected in consideration of the difference between the two measurements and by formation of the quotient from the contents of HbA1c and the previously determined total haemoglobin. Inherent colouring R2 at nm in mE separate batch. Haemolysis of the erythrocytes can basically be effected with all mechanical, chemical or osmotic haemolysis diays or methods, of which the man skilled in the art knows that they lead to complete haemolysis of the erythrocytes.

The method according to claim 1, wherein an operation for determining the total haemoglobin concentration is carried out during or between method steps a -c.


Medium for the specific detection of resistant microorganisms Next Patent: That is a bar to the use of the protease for liquidly stable reagents with a uniform quality requirement over prolonged periods of time. Preferably the zwitterionic detergent has exactly two functional groups of opposite charges so that the molecule overall is electrically neutral.


In that respect the following application formed the basis for measurement on the Hitachi After the addition of the haemolysis solution the pH-value of the haemolysate corresponds to that of the haemolysis solution.

Accordingly the protease thermolysin is markedly better protected against self-digestion in temperature-independent relationship in that composition, than in the other compositions. Ca 2 and chelator: In another embodiment the solution contains 0.

In an alternative embodiment the SH group-trapping agent, for example NEM, is contained in a reagent solution which is kept separately from the reagent solution and is added, in which there is a leuco dye stabilised with thioalcohols.

The method according to claim 1, wherein the stabiliser used is a mixture of two or more chemical compounds of the above-indicated kind. The peroxidase already introduced into the composition by way of the first reagent solution R1in the presence of the resulting hydrogen peroxide, causes oxidation of the leuco dye towards its coloured oxidation form.

Search Expert Search Quick Search. In the embodiments which are present in the form of copolymers they include, besides the units with the above-specified general formula IIthey include further methacrylate units which are esterified with aliphatic or aromatic residues. To ensure that that conversion does not already occur prior to implementation of the actual detection reaction it is advantageous if the leuco dye is stabilized in its colourless reduced form without the actual detection reaction being adversely influenced thereby.

In certain embodiments the concentration is in the range of 10 to 20 mol. Besides the above-described method the present invention also proposes reagent kits for use in a method of determining the amount of HbA1c in a sample, which are characterised in that they comprise at least two different solutions in separate containers, wherein the at least two different solutions are respectively of such a composition that the various aspects of the invention described in detail hereinafter are implemented.