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 respons® Order Information.

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In an dizsys of the present invention stabilisation of the leuco dye is effected in the method of determining the amount of HbA1c in a sample in that, in the method method steps a to c are performed, and quantification of the glycated haemoglobin degradation products is effected in method step c by oxidation thereof by means of FPOX or FAOX with the production of hydrogen peroxide and by determining the resulting amount of hydrogen peroxide, wherein the amount of hydrogen peroxide is quantified on the basis of the colour reaction of a leuco dye in the presence of a peroxidase, and wherein the leuco dye is produced in a solution which for stabilisation of the dye contains a compound of the general formula IV: After the addition of the haemolysis solution the pH-value of the haemolysate corresponds to that of the haemolysis solution.

The term phosphatidylcholine is used here to denote a compound of hbac general formula I: Preferably the aim of the method according to the invention and the reagents according to the invention is to permit total haemoglobin determination at the same time as determining the amount of Hba1x.

A plurality of thio compounds were checked in respect of their dye-stabilising action upon use in combination with TCEP. The method according to claim 1, wherein the stabiliser is used with a concentration in the range of 0. The first reagent solution R1 is then added to the haemolysate resulting therefrom, the result of this being that the FPOX contained in the first reagent solution already breaks down endogenous fructosyle peptides possibly present, but not the terminal fructosylated peptides which are relevant to HbA1c determination as they are not yet released.

Under the above-specified conditions the results shown in Table 3 were achieved. Uba1c principle however it is also possible to correspondingly use any other analysis method for quantifying the amount of hydrogen peroxide in a sample. Accordingly in certain embodiments of the invention the leuco dye is produced in a solution which for stabilisation of the dye contains at least one compound of the general formula I like for example TCEP and at least one thio compound like for example thiodiglycol.

In principle all diass acting means known to the man skilled in the art fall to be considered like for example proteases, wherein a means in accordance with the present invention has a proteolytic effect when it leads to cleaving of proteins by hydrolysis of the peptide bonds. Preceding efficient unfolding of haemoglobin and also stabilisation of that unfolded form are of essential significance for accurate measurement of Hb and HbA1c.

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The differing signal for Level 1 and Level 2 with different storage conditions is due to the different concentration of haemoglobin of the two calibrators. Aspect 2—Stabilisation of the Unfolded Hemoglobin Besides stabilisation of the protease the inventors of the present invention also yba1c 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.

TruCal HbA1c liquid – DiaSys Diagnostic Systems GmbH

In that case the respective HbA1c determination was measured and assessed. The method according to claim 1, wherein the stabiliser used is a mixture of two or more chemical compounds of the above-indicated kind.

In the embodiments in which quantitative determination of the HbA1c is ultimately effected on the basis of the hydrogen peroxide formed in the detection reaction at least one of the above-mentioned reagent solutions contains a peroxidase and at least another of the reagent solutions contains a leuco dye.

Stabilisation of the protease, shown in FIG. The molar ratio of chelator: 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: The present invention concerns a method of determining the amount of glycated haemoglobin HbA1c in a sample and a reagent kit which can be used in a method of determining the amount of glycated haemoglobin HbA1c in a sample.

In accordance with a first aspect the above-described object of the invention is attained in that there is proposed a method of determining the amount of HbA1c in a sample, in which—insofar as required—method steps a to c are performed.

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In the conventional methods of determining the amount of HbA1c unfolding is effected at a pH-value of about 5. The protease apo enzyme contained therein for example thermolysin apo enzyme is activated by the additional divalent metal ions for example zinc ions already contained in the composition by way of the haemolysis solution and cleaves inter alia N-terminal glycated peptide from the beta chain of the haemoglobin.

Inter alia the following metalloproteases belong to the clan MA: The inventors of the present application found that effective stabilisation of leuco dyes can be achieved by the addition of compounds of the general formula I without the actual detection reaction in the present case detection of hydrogen peroxide in the presence of the enzyme peroxidase being adversely effected or damaged thereby.

In the embodiments with multiply unsaturated fatty acid residues they are preferably doubly, trebly or quadruply unsaturated and in certain embodiments independently of the degree of saturation the fatty acid residues are selected from those with a chain length in the range of C8 to C22 or those with a chain length in the range of C16 to C22 for example 1, 2-dioleoyl-sn-glycerophosphocholine.

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In addition there is proposed a reagent kit for use in a method of determining the HbA1c in a sample, which is characterised in that the reagent kit includes at least two different solutions in separate containers, wherein the one solution has a pH-value in the range of 1 to 8 and contains the above-mentioned components i to iiiwherein the molar ratio of chelator: In an aspect of the present invention stabilisation of the leuco dye is effected in the method of determining the amount of HbA1c in a sample in that, in the method method steps a to c are performed, and quantification of the glycated haemoglobin degradation products is effected in method step c by oxidation thereof by means of FPOX or FAOX with the production of hydrogen peroxide and by determining the resulting amount of hydrogen peroxide, wherein the amount of hydrogen peroxide is quantified on the basis of the colour reaction of a leuco dye in the presence of a peroxidase, and wherein the leuco dye is produced in a solution which for stabilisation of the dye contains a compound of the general formula IV:.

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.

In that case the signal of HbA1c determination was measured over a period of minutes on the analyser and respectively related to the freshly ascertained HbA1c value. In many aspects of the present invention there is no need for the protease used to lead to given degradation products. In the embodiments in which haemolytically acting detergents are used they are preferably stored and used in the form of a haemolysis solution.

Search Expert Search Quick Search. Stabilisation of the Leuco Dye with Thio Compounds A plurality of thio ha1c were checked in respect of their dye-stabilising action.

A further object that the inventors of the present application set themselves is stabilisation of the leuco dye in the methods of determining the amount of HbA1c in a sample, in which such a leuco dye is used. Accordingly only one direct measurement after 2 to 15 minutes would also be possible. The amount of calcium or magnesium ions can also be freely selected in the above-mentioned ranges of concentration. Such SH group-containing compounds can however interfere with the actual HbA1c detection reaction and more specifically at the site at which FPOX or FAOX reacts the fructosylated amino acids or peptides forming hydrogen peroxide and the hydrogen peroxide resulting therefrom is quantified.