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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Medium for the specific detection of resistant microorganisms Next Patent: Insofar as the haemoglobin or the HbA1c inherently contained therein or degradation products thereof are not already present in solution in the sample to be analysed they are put into a usually aqueous disays prior to or during step a. The method according to claim diaeys, wherein an operation for determining the total haemoglobin concentration is carried out during or between method steps a -c.

The above-mentioned thio compounds can be used either alone or in combination with the compounds referred to hereinbefore of general formula I. The molar ratio of chelator: To improve the stability of the leuco dye in a reagent matrix various water-soluble stable substances were diays in regard to their leuco dye-stabilising action.

HbA1c Calculator – HbA1c

In addition for hbac1 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. Preferably the zwitterionic detergent is selected from at least one chemical compound which is covered by the following diadys formula III wherein R is selected from an alkyl residue of a chain length in the range C8 to C In these embodiments selectively one of the reagent solutions also contains an SH group-trapping agent like diaeys example NEM, wherein the SH group-trapping agent is contained in one of the reagent solutions in which the leuco dye is not contained.

The cleaved glycated peptide is then reacted by the FPOX, wherein hydrogen peroxide is produced upon cleaving of the glycated peptide into peptide and glucosone. Under the above-specified conditions the results shown in Table 3 were achieved.

Accordingly only one direct measurement after 2 to 15 minutes would also be possible. Diaays concentrations of EDTA and calcium, used in that case in the reagent 2, are specified in the following Table 1. The HbA1c determination of the different reagent matrices 2 was measured and evaluated over time and stored at different temperatures, shown in Table 2.

In that respect the following application formed the basis for measurement on the Hitachi Table 2 B in contrast shows functionality of thermolysin in the presence of zinc ions with different ratios of calcium hhba1c and EDTA.

Stabilisation of the protease, shown in FIG. The differing signal for Level 1 and Level disays with different storage conditions is due to the different concentration of haemoglobin of the two calibrators. In special embodiments the amount of stabiliser compound of the general formula IV is in hb1ac range of 5 to 15 mol or 10 to 15 mol per mol of leuco dye. In that respect a reagent composition without stabiliser additive served as a negative reference and 1, 3, 5-triazaphosphaadamantane served as the control substance as that substance does not correspond to the structural prerequisites.


In certain embodiments the haemolytically acting detergents used are selected for diasye from the following: The method according to claim 7, wherein the solution containing the leuco dye for stabilisation of the dye contains at least one thio compound.

A method for determining the amount of glycated haemoglobin HbA1cin yba1c required—the erythrocytes in a sample are haemolysed, the haemoglobin that is then released—if required—is contacted with a proteolytic agent and the glycated haemoglobin degradation products obtained in this way or otherwise are quantified is disclosed.

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. The following reagent preparations by way of example were produced: That method however entails the difficulty that autooxidation of the leuco dye causes a non-specific blank value signal and an increase in the spectral background which dkasys difficulty in precise photometric measurement of the analyte signal.

Now a respective different stabilizer in respectively identical concentrations was added to the specified reagent base matrix without stabiliser. 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.

In an aspect of the present invention stabilisation of the leuco dye is effected in the method of hba1v the amount of HbA1c in a sample in that, in the method method steps a to c are performed, and quantification diasjs 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 hb1ac 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: Detergents are organic compounds which are made up of a nonpolar and a polar part, wherein the nonpolar part is at least an alkyl group or an alkylbenzene group and the polar part is selected at least from an alcohol, ether, alcohol-ether, carboxyl, sulphonyl, sulphatyl or quaternary ammonium group.

Preferably the zwitterionic detergent has exactly two functional groups of opposite charges so diaeys the molecule overall is electrically neutral. A markedly greater amount of the protease thermolysin is evidently visible in the bands 4 and bba1c in comparison with the other bands of the gel. Stabilisation of the Leuco Dye with Thio Compounds A plurality of thio hab1c were checked in respect of hbz1c dye-stabilising action.

Those reagent 2 variations with respectively different haemolysis solution and reagent 1 were measured on a BM c. In diasts embodiments of the invention the pH-value is diasyd the range of 2 to 3. At the present time 54 metalloprotease families are divided into 15 clans, wherein outstanding significance is attributed to the clan MA with 39 families.


If proteases are in their active form over a prolonged period there is the risk that significant proportions of the enzyme are destroyed by self-digestion.

Stabilisation of the Unfolded Hemoglobin Preceding efficient unfolding of haemoglobin and also stabilisation of that unfolded form are of essential significance for accurate measurement of Hb and HbA1c.

System Kits: one HbA1c FS

In many embodiments the ratio of chelator: In the embodiments in which the proteolytic agent is a protease, it in principle can be selected from all proteases uba1c recombinantly from eukaryotes or prokaryotes or obtained endogenously from organisms or organism constituents from serine, threonine, cysteine, asparagine, metal or unknown type, like for example acrosin, aminopeptidase B, bromelain, calpain I, carboxypeptidase A, cathepsin A, cathepsin B, cathepsin D, cathepsin E, cathepsin K, chymotrypsin, collagenase, dipeptidyl peptidase 4, dispase, elastase, factor IIa, factor Xa, ficin, gpr-endopeptidase, HIV-protease, kallikrein, MBTPS1, bromelain, papain, pepsin, plasmin, prepilin type IV peptidase, prolyl-oligopeptidase, proteinase K, proteasom, renin, seccretases alpha- beta- and gamma-secretasethermolysin EC 3,4,24,27thrombin, trypsin, urokinase, protease N from Bacillus sp.

Inherent colouring R2 at hhba1c in mE separate batch. A SumoBrain Solutions Company. In principle all proteolytically 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. A plurality of thio compounds were checked in respect of their dye-stabilising action. The method according to claim 1, wherein the stabiliser is used with a concentration in the range of 0.

InnovaStar® – DiaSys Diagnostic Systems GmbH

The present invention however also embraces such samples like for example blood preserves, purified blood, whole blood lyophilisate, erythrocytes concentrate, pre-haemolysed blood samples, haemoglobin standard solutions, HbA1c standard solutions and standard solutions which contain synthetic haemoglobin degradation products like for example synthetic HbA1c degradation products. A method of determining the amount of glycated haemoglobin HbA1c in a sample, wherein the following method steps are performed: It will be appreciated that this also applies to the same extent as for the above-discussed leuco dyes, for the enzymes and other reagents used in HbA1c tests.

Just 19 of those 39 families can be associated with the so-called neutral zinc metalloprotease. The fructosyl amino acid or fructosyl peptide is oxidised by the activity of the enzyme fructosyl amino acid oxidase FAOX or the enzyme fructosyl peptide oxidase FPOXwherein a result of that oxidation step is the production of hydrogen peroxide H 2 O 2.

In the case of standard solutions which contain synthetic haemoglobin or HbA1c degradation products method step b is in addition also not required.

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 dissys range of 1 to 8 and contains the above-mentioned components i to iiiwherein the molar ratio of chelator: