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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Preferably the stabiliser is used with a concentration in the range of 0. In an embodiment the pH-value of the haemolysis solution is in the range of 2. The reagent kit according to claim 11, wherein the solution R2 for stabilising the leuco dye contains at least one thio compound, wherein the at least one thio compound is preferably selected from thiodiglycol, thiomalic acid, thionicotinamide, thio-NAD and mixtures thereof.
One means or method in accordance with the present invention is deemed to be haemolytically acting when it leads to dissolution of the erythrocytes by destruction of the cell membrane and transfer of the haemoglobin contained in the erythrocytes into the ambient medium.
Calibrators: TruCal HbA1c liquid
Examples of compounds of the general viasys IV are tris dixsys phosphatin TCEPbis p-sulphonatophenyl phenylphosphine dihydrate dipotassium salt, 1,3,5-triazaphosphine adamantane, tris 3-sulphonatophenyl phosphine hydrate sodium salt, tris 4,6-dimethylsulphonato-phenyl phosphine trisodium salt hydrate, tris hydroxymethyl phosphine, di-t-butyl 3-sulphonatopropyl phosphine, diphenyl m-sulphonatophenyl hha1c dihydrate sodium salt, and [2-dicyclohexylphosphino ethyl]-trimethyl ammonium chloride without the intention being that diasyss invention is to be carried out only with those compounds which are only listed by way of example.
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.
The above-mentioned thio compounds can be used either alone or in combination with the compounds referred to hereinbefore of general formula I.
The method according to claim 1, wherein the stabiliser used is a mixture of two or more chemical compounds of the above-indicated kind. 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:.
The method according to claim 1, wherein the at least one stabiliser is a phosphatidylcholine of the general formula I wherein R 1 and R 2 are selected from completely unsaturated or singly or multiply unsaturated straight-chain or branched-chain fatty acid residues of a chain length in the range of C8 to C The results shown in FIG.
Just 19 of those 39 families can be associated with the so-called neutral zinc metalloprotease.
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.
That is a bar to the use of the protease for liquidly stable reagents with a uniform quality requirement over prolonged periods of time. A comprehensive explicit representation of all conceivable combinations of features is dispensed with here only for the sake of brevity and readability of the description. The actual HbA1c determination operation can then be effected by photometric measurement for example very quickly for example 10 to 30 seconds, depending on the nature of the measuring instrument after addition of the second reagent solution R2that is to say immediately before the FPOX-induced reaction occurs, and once again at a later time for example 2 to 15 minutes, depending on the respective nature of the measuring instrument after the addition of R2, that is to say after conclusion of the hydrogen peroxide-induced oxidation of the leuco dye.
A SumoBrain Solutions Company.
Table 2 C shows the AmE loss of the individual calibrators under different storage conditions. An aliquot without stabiliser substance served in that case as a reference. A method of determining the amount of glycated haemoglobin HbA1c in a sample, wherein the following method steps are performed: In an embodiment the solution contains 0.
The released glycated haemoglobin is then brought into contact with a proteolytic agent to produce glycated haemoglobin degradation products. Synthesis of beta-lactam antibacterials using soluble side chain esters and enzyme acylase. In a special embodiment of the present invention the reagent kit comprises three reagent solutions having the following constituents: The metal ions can be used in the reagent solution employed in any suitable salt form as long as the selected salt form affords the required amount of dissolved metal ion in the batch like for example chlorides, nitrates, sulphates, formiates and acetates.
In most cases the sample will be a sample of fresh whole blood.
QDx Instacheck™ – DiaSys India
Stabilisation of the Leuco Dye with Phosphines To diasjs the stability of the leuco dye in a reagent matrix various water-soluble stable substances were checked in regard to their leuco dye-stabilising action. Aspect 2—Stabilisation of the Unfolded Hemoglobin 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 an embodiment of the present invention the various reagents used in HbA1c determination are brought together in the form of the following solutions which are provided in separate containers: In detail the results of the following batches are shown in FIG. Hb1c 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.
System Kits: one HbA1c FS
Accordingly only one direct measurement after 2 to 15 minutes would also be possible. 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 hbw1c oxidation form. In the conventional methods of determining the amount of HbA1c unfolding is effected at a pH-value of about 5.
A comprehensive explicit representation of all conceivable embodiments is dispensed with here only for the sake of brevity and readability of the disys.
It is further pointed out that it is self-evident to the man skilled in siasys art that the embodiments by way of example hereinafter only serve to set forth by way of example the possible embodiments of the present invention, that are set out as examples of the invention.
The following reagent preparations by way of example were produced: A HbA1c riasys signals. A method for determining the amount diaasys glycated haemoglobin HbA1cin which—if 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.
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 hbx1c C8 to C22 or those with a chain length in the range of C16 to C22 for example 1, 2-dioleoyl-sn-glycerophosphocholine.
InnovaStar® – DiaSys Diagnostic Systems GmbH
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 diasyx 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: Medium for the specific detection of resistant microorganisms Next Patent: In principle however diasyys is also possible to correspondingly use any other analysis method for quantifying the amount of hydrogen peroxide in a sample.
The measurement intervals however are very heavily dependent on the diasya employed analyser, photometer and so forth. A plurality of thio compounds were checked in respect of their dye-stabilising action upon use viasys combination with TCEP.
A greater reduction in the HbA1c value however has the disadvantage that the haemoglobin treated in that way hab1c severely denatured and agglutinated and precipitates in that form so that it is no longer available in a suitable form for digestion with a protease.