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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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. The released glycated haemoglobin is then brought into contact with a proteolytic agent to produce glycated haemoglobin degradation products. The term phosphatidylcholine is used here to denote a compound of the general formula I: Those reagent 2 variations with respectively different haemolysis solution and reagent 1 were measured on a BM c.
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: 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.
In a special embodiment of the present invention the reagent kit comprises three reagent solutions having the following constituents: In most cases the sample will be a sample of fresh whole blood.
In detail the results of the following batches are shown in FIG.
In the embodiments in which haemolytically acting detergents are used they are preferably stored and used in the form of a haemolysis solution. Haemolysis of the erythrocytes can basically be effected with all mechanical, chemical or osmotic haemolysis means or methods, of which the man skilled in the art knows that they lead to complete haemolysis of the erythrocytes. In an embodiment the pH-value of the haemolysis solution is in the range of 2. A HbA1c calibration signals.
In a given method of quantifying hydrogen peroxide, a reduced leuco dye is oxidised with hydrogen peroxide.
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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.
Accordingly only one direct measurement after 2 to 15 minutes would also be possible. A comprehensive explicit representation of all conceivable embodiments is dispensed with here only for the sake of brevity and readability of the description. Table 2 B in contrast shows functionality of thermolysin in the presence of zinc ions with different ratios of calcium ions and EDTA. 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 causes difficulty in precise photometric measurement of the analyte signal.
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: A plurality of thio compounds were checked in respect of their dye-stabilising action.
one HbA1c FS – DiaSys Diagnostic Systems GmbH
The measurement intervals however are very heavily dependent on the respectively employed analyser, photometer and so forth. 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. In an embodiment the concentration of the stabiliser compound of the general formula IV is in the range of 2.
In principle however it is also possible to correspondingly use any other analysis method for quantifying the amount of hydrogen peroxide in a sample. Preferably the zwitterionic detergent is selected from at least one chemical compound which is covered by the following general formula III wherein R is selected from an alkyl residue of a chain length in the range C8 to C However, as was already mentioned hereinbefore, there is the risk that the haemoglobin is denatured, agglutinated and precipates, as can also be effected for example by adding trichloroacetic acid.
ENZYMATIC DETERMINATION OF HBA1C – DiaSys Diagnostic Systems GmbH
That is a bar to the use of the protease for liquidly stable viasys with hbac1 uniform quality requirement over prolonged periods of time. 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 fiasys 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:.
A comprehensive explicit representation of all conceivable combinations of features is dispensed with here only for the sake of brevity and readability of the dissys.
The addition of the SH group-trapping agent should accordingly occur at latest immediately prior to carrying out the HbA1c detection reaction. For the purposes of the original disclosure it is pointed out that all features as can hbs1c seen by a man skilled in the art from the present description, the drawings and the claims, even if they are described in specific terms only in connection with certain other features, can be combined both individually and also in any combinations with others of the features or groups of features disclosed here insofar as that has not been expressly excluded or technical aspects make such combinations impossible or dixsys.
In the enzymatic investigation—as moreover is also the case with all other HbA1c methods—the first step is to haemolytically rupture the erythrocytes in hna1c blood sample to release the HbA1c contained therein. In that case the respective HbA1c determination was measured and assessed. Medium for the specific detection of resistant microorganisms Next Patent: In certain embodiments the haemolytically acting detergents used are selected for example from the following: The results shown here impressively demonstrate the storage capability of an inactivated but structurally stabilised thermolysin in a liquid reagent matrix over various temperatures and time and the reactivatability thereof.
After the reaction is substantially concluded photometric determination of the total haemoglobin content of the pre-incubated haemolysate is effected.
In diawys embodiments the ratio is inn the range of 1: In accordance with the invention the above-described object is attained by various aspects which are described in detail hereinafter and which usually have the common denominator that they comprise a method of determining the amount of HbA1c in a sample, in which the following method steps are performed:.
Changing from Glucose to HbA1c for Diabetes Diagnosis
The inventors of the present application found that this specific amount of the respective divalent metal ions is sufficient to reoccupy the sites in the protein structure of the protease, that are required for activation of the protease, in spite of the simultaneously present significant amounts of chelator and calcium or magnesium ions. Preferably the zwitterionic detergent has exactly two functional groups of opposite charges so that the molecule overall is electrically neutral.
The following reagent preparations by way of example were produced: 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 djasys determining the amount of glycated haemoglobin HbA1c in a sample. In many embodiments of the invention however a protease is specifically used, whose proteolytic activity leads to the release of fructosyl valine histidine or fructosyl valine from the amino-terminal end of the beta chain of glycated haemoglobin.
Aspect 3—Stabilisation of the Leuco Dye 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 diaasys, in which such a leuco dye is used.
Accordingly the amount of hydrogen peroxide produced in this step is a measurement in respect of the amount of HbA1c in the sample.